Efficacy of Arsenicum Alb 30c For Upregulating Immunological Markers Among Residents of Covid 19 Related Hot Spot Areas in Pathanamthitta Kerala

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EFFICACY OF ARSENICUM ALB 30C FOR UPREGULATING IMMUNOLOGICAL

MARKERS AMONG RESIDENTS OF COVID-19 RELATED HOT SPOT AREAS IN
PATHANAMTHITTA, KERALA
Preprint · July 2020

DOI: 10.13140/RG.2.2.26387.71200
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i
COVID-19 RESEARCH
HOMOEOPATHY
EFFICACY OF ARSENICUM ALB 30C FOR UPREGULATING
IMMUNOLOGICAL MARKERS AMONG RESIDENTS OF
COVID-19 RELATED HOT SPOT AREAS IN
PATHANAMTHITTA, KERALA
THOMAS M. V*
Research In Homoeopathy, Kerala
BIJUKUMAR D
Department of Homoeopathy, Kerala.
NIRMAL GHOSH O.S

Homoeopathic Medical Education, Kerala
MURALEEDHARAN K.C
National Homoeopathy Research Institute in Mental Health, Kerala
BIJU S.G
Homoeopathic Multi-Speciality Clinic, Kottayam, Kerala.
ii
Special Thanks to
Dr. Vijayambika M.N

Director, Department of Homoeopathy. Kerala
Dr. Jayanarayanan R
State Program Manager, National Ayush Mission. Kerala
Dr. Paul Muttathukunnel

Switzerland
iii
TABLE OF CONTENTS
Contents Page
No
Preface vii
Acknowledgements xi
Abbreviations xiv
Abstract 1
Chapter Topic
1.INTRODUCTION 2
Epidemics and Pandemics 3
Stress and Immunity 5
Objectives of the Study 6
2.REVIEW OF LITERATURE 10
Immune System 11
Cells of Cellular Immune System 12
T-Lymphocytes 13
CD3, CD4 and CD8 Cells 14
CD4:CD8 Ratio 14
Psychoneuroimmunology 15
Psychological Stress and Immunity 16
Homeopathy and Immunity 17
Hypotheses 18
3.METHODS 19
Phase-1 21
iv
Design 21
Population 21
Participants 21
Tools 24
Procedure for Data Collection 24
Statistical Analysis 25
Phase-2 25
Design 25
Population 26
Participants 26
Tools 29
Intervention Technique 29
Procedure for Data Collection 30
Instructions to Participants 31
Statistical Analysis 32
4.RESULTS 33
Results of Exploratory Phase-1 34
Classification of Participants 35
Analysis of IES-Score and Sex 38
Analysis of IES-Score and Age 39
Results of Experimental Study Phase-2 41
Pre-post Assessment of Absolute CD4 Count 44
Pre-post Assessment of Absolute CD8 Count: 46
Females
v
Males
Pre-post Assessment of Absolute CD4 Count:
Females
Males
Females
Males
Pre-post Assessment of Absolute Lymphocyte 62
Count
Count: Females
Count: Males
Pre-post Assessment of CD4:CD8 Ratio 67
Pre-post Assessment of CD4:CD8 Ratio: 68
Females
Pre-post Assessment of CD4:CD8 Ratio: Males 69
vi
Psychoneuroimmunology and Homoeopathy 71
Epidemic Prophylaxis 73
Hypothetical Proposition on Modus Operandi of
Arsenicum Album 30C 74
Homoeopathic Management of COVID-19 75
Pandemic
5.SUMMARY AND CONCLUSION 76
Major Findings 78
Implications 80
Limitations 80
Recommendations 80
Suggestions for Further Research 81
Conclusion 82
REFERENCES 83
APPENDICES 92
Appendix-1 Personal Data Schedule 93
Appendix-2 Informed Consent 94
Appendix-3 IES-R (Malayalam) 95
Appendix-4 HIB Schedule 99
ABOUT AUTHORS 102
vii
PREFACE
“When Pandora’s curiosity got the best of her, she opened the forbidden box,
unknowingly allowing hunger, pestilence, sickness, poverty, crime and vice to escape
into the world. Only one thing remained – hope. When Pandora opened the box
again, hope also entered into the world, with a lot of catching up to do”
-from the epilogue of Pandora’s Lab written by Paul A. Offit.
According to Greek mythology, Pandora is the first woman who was created by
Hephaestus by the order of Zeus. Pandora was created to combat the mortals, after Prometheus
blessed the humanity with stolen fire. She opened her jar (box) and all evils came out it
including pestilence. It was the bubonic plague ambiguously mentioned as pestilence. And
fortunately, she had unknowingly released one good thing named as HOPE.
We are in the midst of a battle with a pestilence, the COVID-19 Pandemic. With all
available weapons in hand, human race battling against the microscopic creatures who are
sometimes alive and sometimes dead. Beyond borders, beyond colour whether black or white,
without religion and caste, putting hands together and asking all the means to fight and conquer.
The science crew searching new ideas and medical world conducting possible clinical trials for
the prevention and management of COVID-19. But the reports from labs are hopeless and
seemed to be skewed by the pharma mafias as if money is the matter.
viii
The COVID-19 is a new pandemic. The causative organism is a virus belonging to
Coronaviridae family and named as SRS-CoV-2. The symptoms are resembling SARS with
high reproducibility and comparatively low mortality rate except risk factors such as chronic
lung diseases, liver diseases etc. Having, high transmission rate, the epidemic creates
considerable stress among individuals living in the hot spot areas and containment zones. It is
a global crisis which essentially creates multifaceted-stress among a very large population. It
causes both physical and psychological stress, financial crisis, reduces job opportunities, and
develops poverty. More than 5 lakhs deaths were reported globally, 24309 deaths in India and
more than 30 deaths in Kerala.
Homoeopathy is an alternative way to restore health in stressed situations like this.
Homoeopathy proved its worth as a prophylactic tool in many occasions, like Dengue Fever,
Chikungunya Fever, and Epidemic Cholera at Attappadi, Kerala. Research findings and certain
anecdotal evidences are in favour of homoeopathy for disease prevention at its prodromal stage.
Homoeopathy is best suited to secondary level of disease prevention, since the genus
epidemicus can be developed only after reporting a disease in a population.
It was hypothesised that, homoeopathic medicines maintain immunity in stressed
situations which helps in disease prevention. Not all the individuals get infected with the
disease, but those who are more susceptible or in other words less immune. The interventions
that are focussed to maintain good immunity to make them to stay away from infection. The
present study was conducted to find out whether homoeopathy is beneficial for maintaining the
immunity. The study was based on the theoretical framework of psychoneuroimmunology and
homoeopathy.
As a scientific research, especially in homoeopathy we have deployed our highest-level
of commitment. Discussed with the experts in the field of homeopathy, psychology,
ix
immunology, biotechnology and statistics. Collected data directly from participants with
utmost care and analysed unbiased. Now, the subjective distress, immunological markers and
Arsenicum album 30C are in your hands for reading and evaluation. You may find language
errors, but we tried our best to stand on scientific methods. We hope, the study will be a
milestone laid for the development of experimental research in homoeopathy.
And the HOPE came out of Pandora’s box, we hold it in our hearts...
Thomas M.V
Bijukumar D
Nirmal Ghosh O.S
Muraleedharan K.C
Biju S.G
17th July, 2020
x
ACKNOWLEDGEMENTS
Research during a pandemic is absolutely same as in a warfront. We the soldiers are stepping
forward to combat with a common enemy, the novel corona virus-SARS-CoV-2. It was
tiresome with sleepless nights, lock down days, stressful moments and finally we did it!
Need to say thanks to many...
We would like to extend our immense gratitude to
Dr. Manikandan, Professor, Department of Psychology, University of Calicut.
Dr. Jayadevi Varrier, Associate Professor, Department of Biotechnology, Kannur University.
Sri.N.Ramakrishnan, Department of Statistics, Government of Kerala.
Dr. Ragee Ramakrishnan, Shilpa Homoeopathic Specialty Clinic, Vadakara, Kozhikode.
Dr. Arun Krishnan K.P, Research In Homoeopathy, Kerala
Dr. A.T.Suresh, Research In Homoeopathy, Kerala
Dr. Rithesh B, Associate Professor, Government Homoeopathic Medical College, Kozhikode.
Dr.Dileepkumar K.B. Research In Homoeopathy, Kerala
Dr. Reghu, SVRM Homoeopathic Medical College, Trivandrum
Dr.Rejikumar, Medical Officer GHD Kodumon
Dr. Sheeba, Medical Officer GHD Naranganam
Dr.Preethi Aleyamma John, Medical Officer , GHH Kottanad
Dr.Hareesh, Medical Officer, National Ayush Mission
xi
Dr.Meera Mohan, Medical Officer, National Ayush Mission
Dr.Biji Daniel, GHD, Pandalam
Dr.Raji NHMD, Kadambanadu
Dr.John Jacob GHD Peringara
Dr. Mini M.R, GHD, Thottappuzhasseri
Dr.Padmaja, GHD, Kuttappuzha
Dr. Dr. Jyothilakshmi, NHMD Niranam,
Dr. Jisha V.S, GHD, Vadasserikkara
Dr. Shalima, GHD Puthusserimal
Dr.Karanan, NHMD, Ranni, Perunadu
Dr.Aswin Kumar, NHMD Ranni Angadi
Dr. Shajitha Beegum, NHMD Cherukol
Dr. Remya Deth, GHD, Pramadam
Dr. Shiji T.A, GHD Seethathodu
Dr. Lakshmi Darling, NHMD, Konni
Dr. Smitha, GHD, Kulanada
Dr. Sangeetha V.C, GHD, Chenneerkkara.
Dr. Seethal Naveen, GHD, Elanthoor
Dr. Reshmi, NHMD, Omalloor
Dr. Bernett Ipe, DHH, Kottanad
Dr. Radhakrishnan, GHD, Kallooppara
Dr. Sagitha Sathyan, GHD, Chungappara
Dr. Preethi Sam, NHMD, Kunnathanam.
Dr. Nivedha K.S. Research Officer, AYUSH , Trivandrum.
Sri. Nissar (Superintendent, DMO Office (Homoeo) Pathanamthitta)
xii
Sri. Rishad (Pharmacist, GHD Kulanada)
Sri. Rahim (Driver, DMO (Homoeo) Pathanamthitta)
Smt. Madhuri (SC Cordinator, Adoor)
Sri. Shaji (Muthoot Health Plus, Adoor)
Staff and technicians Muthoot Health Plus, Adoor
Team Research In Homoeopathy, Kerala
Team SAHYA, Kerala
Finally,
The participants who signed the Informed Consent and co-operated with us for the great event!
Thomas M.V
Bijukumar D
Nirmal Ghosh O.S
Muraleedharan K.C
Biju S.G
xiii
ABBREVIATIONS USED
SlNo Abbreviations Expansions
1 WHO World Health Organization
2 CD Communicable Diseases
3 NCD Non-Communicable Diseases
4 COVID-19 Corona Virus Disease-2019
5 NIH National Institutes of Health
6 ASD Acute Stress Disorder
7 PTSD Post-Traumatic Stress Disorder
8 PNI Psychoneuroimmunology
9 SARS-CoV-2 Severe Acute Respiratory Syndrome Corona Virsu-2
10 HLA Human Leukocyte Antigen
11 TCR T-Receptor Complex
12 MHC Major Histocompatibility Complex
13 CTL Cyto Toxic Cells
14 ANS Autonomic Nervous System
15 HPA Hypothalamus Pituitary Pathway
16 DHEA
17 PDS Personal Data Schedule
18 SQS Single Question Screening
19 IES-R Impact of Events Scale-Revised
xiv
20 ANOVA Analysis of Variants
21 SBP Systolic Blood Pressure
22 DBP Diastolic Bloop Pressure
23 PR Pulse Rate
24 BMI Body Mass Index
25 ALC Absolute Lymphocyte Count
26 AIDS Acquired Immuno Deficiency Syndrome
27 HIV Human Immuno Virus
28 CFLTC COVID-19 First Line Treatment Centre
29 CD3 Cell surface glycoprotein related to TCR
30 CD4 Cell surface glycoprotein related to MHC class II
31 CD8 Cell surface glycoprotein related to MHC class I
xv
LIST OF TABLES
SlNo Table No Title Page No
1 3.1 List of Taluks and Panchayaths selected for Data Collection 22
2 3.2 One Group Before After Design 26
3 3.3 Normal Mean Values of Immunological Markers (Indian 29
Population)
4 3.4 Details of Intervention Technique 30
5 3.5 Date and time of Collection of Blood Samples 31
6 4.1 Classification of Participants on Sex 35
7 4.2 Classification of Participants on Age Groups 36
8 4.3 Clinical Significance of IES-R Score among Participants 37
9 4.4 Mean IES-R Score of the Study Group 37
10 4.5 Comparison of IES-R Score on Sex: Results of Independent 38
‘t’ Test
11 4.6 IES-R Score, Mean, SD of Age Groups 39
12 4.7 Comparison of IES-R Score among Age Groups: Results of 40
ANOVA
13 4.8 Age, Sex, & Absolute CD4 Count of Participants at Entry 42
Point
14 4.9 Mean, & SD of Absolute CD4 of Males, Females and Group 43
15 4.10 Demographic Parameters of the Participants 43
xvi
16 4.11 Comparison of Pre & Post Assessment of Absolute CD4 45
Count: Results of Paired ‘t’ Test
Count among Females: Results of Paired ‘t’ Test
Count among Males: Results of Paired ‘t’ Test
Count: Results of Paired ‘t; Test
Count: Results of Paired ‘t’ Test
25 4.20 Comparison of Pre & Post Assessment of Absolute 62
Lymphocyte Count: Results of Paired ‘t’ Test
Lymphocyte Count among Females: Results of Paired ‘t’ Test
Lymphocyte Count among Males: Results of Paired ‘t’ Test
xvii
28 4.23 Comparison of Pre & Post Assessment of CD4:CD8 Ratio: 67
Results of Paired ‘t’ Test
29 4.24 Comparison of Pre & Post Assessment of CD4:CD8 Ratio 69
among Females: Results of Paired ‘t’ Test
30 4.25 Comparison of Pre & Post Assessment of CD4:CD8 Ratio 70
among Males: Results of Paired ‘t’ Test
xviii
LIST OF FIGURES
SlNo Figure No Title Page No
1 3.1 Brief Out Line of the Study 20
2 3.2 Flow Chart: Sample Selection 23
3 3.3 Flow Chart: Sample Selection 27
4 3.4 Research Team for Data Collection 28
5 4.1 Scores of IES-R among Males and Females: Bar Diagram 38
6 4.2 Number, IES-R Score & SD of Participants: Bar Diagram 40
7 4.3 Absolute CD4 Count of Participants: Bar Diagram 42
8 4.4 Immunological Markers on Entry Point: Scattered Graph 44
9 4.5 Pre/Post Assessment of Absolute CD4 Count: Line Graph 46
10 4.6 Pre/Post Assessment of Absolute CD4 Count among 47
Females: Line Graph
Males: Line Graph
12 4.8 Mean Values of CD4 Count- Pre-Test, Post-Test and 50
Indian Population: Bar Diagram
Females: Line Graph
xix
Males: Line Graph
Females: Line Graph
Males: Line Graph
21 4.17 Pre/Post Assessment of Absolute Lymphocyte Count: Line 63
Graph
22 4.18 Pre/Post Assessment of Absolute Lymphocyte Count 64
among Females: Line Graph
23 4.19 Pre/Post Assessment of Absolute Lymphocyte Count 65
among Males: Line Graph
24 4.20 Mean Values of Lymphocyte Count- Pre-Test, Post-Test 66
and Indian Population: Bar Diagram
25 4.21 Pre/Post Assessment of CD4:CD8 Ratio: Line Graph 68
26 4.22 Pre/Post Assessment of CD4:CD8 Ratio among Females: 69
Line Graph
27 4.23 Mean Values of CD4:CD8 Ratio- Pre-Test, Post-Test and 71
xx
LIST OF APPENDICES
Sl Appendix Name of Appendix Page No
No No
1 1 Personal Data Schedule 93
2 2 Informed Consent 94
3 3 Impact of Events Scale-Revised (Malayalam) 95
4 4 Homoeopathic Immune Booster Intervention Schedule 99
xxi
ABSTRACT
The COVID-19 is an epidemic illness caused by SARS-CoV-2 with high reproducibil-
ity rate. The infection was first reported at Wuhan provincial of China in 2019, January. The
disease transmitted very easily around the globe infecting about 50 lakhs individuals. More
than 5 lakhs deaths were reported globally. No specific vaccines or medicines are currently
available for the management of COVID-19. Homoeopathic medicines can be employed as
preventive medicines (Genus Epidemicus) and as an immune booster for those participants
who are under threat of an epidemic or a pandemic. In the current episode of COVID-19 pan-
demic, the homoeopathic medicine Arsenicum alb 30C is selected as the genus epidemicus
after an extensive review. It was hypothesised that, Arsenicum alb 30C will upregulate the
immune markers of the individuals. The immune profile was explained by the serum absolute
counts of CD4, CD3, CD8 and Lymphocyte.
The objective of the current study was to find out whether the homoeopathic medicine
Arsenicum alb 30C triggered the upregulation of CD4, CD3, CD8 and Lymphocyte profiles of
individuals affected with subjective distress due to COVID-19 pandemic. The COVID-19 was
declared as a pandemic, and hence it was considered as biological disaster. The study found
out that, the potentized homoeopathic medicine, Arsenicum album 30C is effective for upreg-
ulating the immunological markers such as absolute CD4 count, absolute CD8 count, absolute
CD3 count, absolute lymphocyte count and CD4:CD8 ratio among the residents of COVID-19
related hot spots. It also found that, COVID-19 pandemic has created different levels of sub-
jective distress as a result of post-traumatic stress disorder (PTSD) at residents of hot spot areas
in Kerala.
Page | 1
CHAPTER ONE
INTRODUCTION
Page | 2
Disease is the altered state of health, where health is a relative concept which denotes
a state of physical, mental and social well-being. The World Health Organization (WHO) de-
fined health as a state of complete physical, mental and social well-being and not merely ab-
(1)
sence of disease or infirmity . Health is maintained by multi-dimensional factors which is
very difficult to attain to the term that implies. Any change or alteration from the state of health,
is termed as disease. The disease is basically classified as communicable disease (CD) and non-
communicable disease (NCD). Epidemics are communicable diseases which are transmitted
by certain host agents.
The epidemics are generally considered to be an unexpected wide spread rise in disease
incidence at a given time (2). An epidemic is defined as the occurrence in a community or region
of cases of an illness, specific health related behaviour, or other health related events clearly in
excess of normal expectancy (1) A pandemic (pan-all; demos-people) is an epidemic of infec-
tious disease that is spreading through human populations across a large region; for instance, a
continent or even worldwide. A disease is not pandemic merely because it is widespread or
kills many people; it must also infectious (3). The National Institute of Health (NIH) of UK in
2009 suggested that a pandemic should meet the following criteria such as wide geographic
extension, disease movement, high attack rates and explosiveness, minimal population immun-
ity, novelty, infectiousness, contagiousness and severity (2).
The COVID-19 is an epidemic illness caused by SARS-CoV-2 with high reproducibil-
ity rate. The infection was first reported at Wuhan provincial of China in 2019, January. The
disease transmitted very easily around the globe infecting about 50 lakhs individuals. More
than 2.5 lakhs deaths were reported globally. The World Health Organization (WHO) declared
COVID-19 as a pandemic in March 11th, 2020. The pandemic very badly affected Indian sub-
continent and made serious injuries to the national development and health sector. The nation-
wide lockdown was called and currently running through its phase 4. Community spread is the
Page | 3
most important threat that we are supposed to face during this COVID-19 pandemic. Among
the Indian states, Kerala could manage the situation exceptionally better through lock down
and breaking the chain procedures. The quarantine and BREAK THE CHAIN procedures are
the only effective methods to reduce community spread. No vaccines or medicines are available
for specific COVID-19 treatment.
(4)
The reproducibility rate of COVID-19 is very high as 2.28 and a considerably less
(5)
mortality rate of 3.6 % . The infection becomes more fatal to those who are having major
systemic illnesses and low immune profiles. Since there are no specific interventions available
for COVID-19, the management is based on symptoms of the patient and preventive measures.
Intervention strategies aiming to upregulate the immune status of the general population and
those who are at risk are highly welcomed and need of the hour. Homoeopathy and homoeo-
pathic medicines serve the suffering humanity at this point. Homoeopathic medicines can be
employed as preventive medicines (Genus Epidemicus) and as an immune booster for those
participants who are under threat of an epidemic or a pandemic.
The epidemics are generally considered as biological related disasters (6). Disasters of-
ten associated with several impacts among the victims and witnesses. There will be psycholog-
ical, social, economic and physical impacts associated with disasters. The psychological im-
pacts are usually categorised as acute stress disorder (ASD) and post-traumatic stress disorder
(PTSD). The COVID-19 pandemic is a biological disaster which causes psychological distress
among the individuals. The affected individuals become distressed because of its mortality
among risk groups and the COVID-19 protocols to be obeyed during isolation or reverse quar-
antine. The unaffected individuals become distressed about chance of getting infection and the
COVID-19 protocols of lock down, quarantine and isolation. All these factors create subjective
distress among individuals and lowers the immunity status.
Page | 4
The psychological distress leading to disturbances in the immune functioning of human
body is explained on the basis of psychoneuroimmunology (PNI). Human studies in psycho-
neuroimmunology underscore the multiple ways in which the bidirectional influence of the
central nervous system and immune system impacts well-being (7). The Pathanamthitta district
was a high-risk area with several confirmed cases in the Ranni Taluk during the study period.
The individuals residing in the area might have subjective distress and thereby low immune
status. The interventions directed to upregulate the immune status may be beneficiary for the
individuals residing in the hot spot areas. The homoeopathic medicine Arsenicum album 30C
can be used for this purpose and the study is aimed to find out its efficacy to upregulate the
immune markers among the individuals with high subjective distress and low immune profile.
It was hypothesised that, Arsenicum alb 30C will upregulate the immune markers of the indi-
viduals. The immune profile was explained by the serum absolute counts of CD4, CD3, CD8
and Lymphocyte.
The genus epidemicus is a homoeopathic medicine selected on the basis of the working
case definition developed after studying the symptoms of the cases presented with the epidemic
illness. The selected medicine can be administered as a preventive medicine as it will upregu-
late the immunity of the individuals against the prevailing epidemic outbreak. In the current
episode of COVID-19 pandemic, the homoeopathic medicine Arsenicum alb 30C is selected
as the genus epidemicus after an extensive review.
The current study was conducted to find out whether the homoeopathic medicine Arse-
nicum alb 30C triggered the upregulation of CD4, CD3, CD8 and Lymphocyte profiles of in-
dividuals affected with subjective distress due to COVID-19 pandemic. The COVID-19 was
declared as a pandemic, and hence it was considered as biological disaster. The disasters are
capable of produce acute stress disorder among individuals who became victims and witnesses.
The affected individuals are isolated and suspected individuals are quarantined and a large
Page | 5
population are left as unaffected. They are chance to get infection whenever a community
spread is observed. So, the unaffected population may have severe acute stress which may
cause low immune status.
The COVID-19 infection causes subjective distress among people residing in hot spot
areas and the subjective distress causes decrease in the level of immunity which can be meas-
ured as lowered absolute counts in CD4, CD3, CD8 and lymphocytes. The homoeopathic med-
icines were given to those individuals who residing in hot spot areas, with high subjective
distress and low immune profiles and a study was conducted to investigate the efficacy of these
medicines for upregulating the immunity status of the individuals.
Objectives of the study
1. To find out whether any subjective distress present among residents of COVID-19
related hot spot areas in Pathanamthitta.
2. To find out the immune status of individuals residing at COVID-19 related hot spot
areas in Pathanamthitta.
3. To find out the efficacy of Arsenicum album 30C for upregulating the immunolog-
ical markers among residents of COVID-19 related hot spot areas in Pathanamthitta.
4. To find out the absolute CD4 count of the participants residing at COVID-19 related
hot spot areas in Pathanamthitta.
5. To find out the absolute CD3 count of the participants residing at COVID-19 re-
lated hot spot areas in Pathanamthitta.
6. To find out the absolute CD8 count of the participants residing at COVID-19 related
hot spot areas in Pathanamthitta.
7. To find out the absolute lymphocyte count of the participants residing at COVID-
19 related hot spot areas in Pathanamthitta.
Page | 6
8. To find out the CD4:CD8 ratio of the participants at COVID-19 related hot spot
9. To find out the efficacy of Arsenicum album 30C for upregulating absolute CD4
count of the participants residing at COVID-19 related hot spot areas in
Pathanamthitta.
Pathanamthitta.
Pathanamthitta.
12. To find out the efficacy of Arsenicum album 30C for upregulating absolute lym-
phocyte count of the participants residing at COVID-19 related hot spot areas in
Pathanamthitta
13. To find out the efficacy of Arsenicum album 30C for upregulating CD4:CD8 ratio
among the participants residing at COVID-19 related hot spot areas in
Pathanamthitta.
count among female participants residing at COVID-19 related hot spot areas in
Pathanamthitta.
Pathanamthitta.
Page | 7
Pathanamthitta.
phocyte count among female participants residing at COVID-19 related hot spot
among female participants residing at COVID-19 related hot spot areas in
Pathanamthitta.
count among male participants residing at COVID-19 related hot spot areas in
Pathanamthitta.
Pathanamthitta.
Pathanamthitta.
phocyte count among male participants residing at COVID-19 related hot spot areas
in Pathanamthitta.
among male participants residing at COVID-19 related hot spot areas in
Pathanamthitta.
Page | 8
Statement of the Problem
The present study is titled as “EFFICACY OF ARSENICUM ALBUM 30C FOR UPREG-
ULATING IMMUNOLOGICAL MARKERS AMONG RESIDENTS OF COVID-19
RELATED HOT SPOT AREAS IN PATHANAMTHITTA, KERALA”.
Operational Definitions
Efficacy: Efficacy is the preliminary trail to find out beneficiary actions of an intervention. It
is defined as the performance of an intervention under ideal and controlled circumstances (8).
Arsenicum album 30C: It is a homoeopathic medicine with 30th centesimal scale potency,
prepared according to the Homoeopathic Pharmacopeia of India (HPI).
Upregulation: It is the process of increase in the cell count of immunological markers to a
state of normal functioning of the immune system.
Immunological Markers: Immunological Markers are the dependent variables selected to
measure the immune status of an individual. The present study used absolute CD3 count, ab-
solute CD4 count, absolute CD8 count, absolute lymphocyte count and CD4:CD8 ratio as Im-
munological Markers.
COVID-19: It is a type of Severe Acute Respiratory Syndrome (SARS) caused by a novel
corona virus named as SARS-CoV-2.
COVID-19 related Hot Spot Areas: An area of actual or potential trouble due to COVID-19
pandemic.
Page | 9
CHAPTER TWO
REVIEW OF LITERATURE
Page | 10
The review of literature describes immune system, its classification, types-adaptive im-
munity in specific, psychoneuroimmunology, homoeopathy and immunity. The adaptive im-
mune system and its immunological markers are specifically included in the study.
Immune System
The immune system is a complex set of tissues with mobile elements, whose function
is to protect the organism from invasion by exogenous microscopic life forms or particles and
to rid the body of defective, damaged or malignantly transformed cells (9). It consists of intri-
cately linked network of cells, proteins and lymphoid organs that are strategically placed to
ensure maximal protection against infections (10). The mechanisms of immune system fall into
two broad categories which are Innate Immunity and Adaptive Immunity.
The Innate Immunity (also called natural or native immunity) refers to the mechanism
that are ready to react to infections even before they occur, that have evolved to specifically
recognize and combat microbes (11). The innate defence mechanisms against infections include
anatomical barrier (such as skin, sweat and mucous membranes), phagocytes (neutrophils,
monocytes and macrophages), dendritic cells, cytokines, compliment system, mast cells, baso-
phils, and natural killer (NK) cells (10).
The Adaptive Immunity (also called acquired or specific immunity) consists of mech-
anisms that are stimulated by microbes and are capable of recognizing microbial and non-mi-
(11)
crobial substances . The two major divisions of adaptive immunity are humoral immunity
involves the antibodies produced by B-lymphocytes; cellular immunity mediated by T-lym-
phocytes which produce cytokines and kill immune targets (10). The humoral immunity is mo-
bilized by B-lymphocytes which are specialized cells in the bone marrow. The B-lymphocytes
produce immunoglobulins (antibodies) which are soluble proteins. There are five classes of
antibodies such as IgG, IgA, IgM, IgE and IgD. The cellular immunity was mediated by T-
lymphocytes which arise in the bone marrow. T-lymphocytes can be segregated into two
Page | 11
subgroups on the basis of function and recognition of Human Leucocyte Antigen (HLA) mol-
ecules. These are designated as CD4+ and CD8+ T-cells according to the ‘cluster differentia-
tion’ antigen expressed on their cell surface.
The T-lymphocyte helper function is centre to all facets of immune responsiveness in-
cluding non-specific response. The T-helper cells remain in a “naïve” state until they encounter
antigen and appropriate cytokine co-stimulation which can facilitate B-cell activation and spe-
cific antibody production (9). Psychological stress has been linked empirically with dysregula-
tion of facets of the human immune system, yet these effects are not same in every situation or
population (12).
Cells of Cellular Immune System
Although T and B lymphocytes and their subsets are morphologically unimpressive and
appear quite similar to one another, they are actually remarkably heterogeneous and specialised
in molecular properties and functions. Among the major classes of lymphocytes B and T lym-
phocytes are cells of adaptive immunity and natural killer (NK) cells are cells of innate im-
munity. Several more classes of lymphocytes have been identified. Lymphocytes and other
cells involved in immune responses are not fixed in particular tissues but constantly circulate
among lymphoid and other tissues via blood and lymphatic circulation. This feature promotes
immune surveillance by allowing lymphocytes to home any site of infection. In lymphoid or-
gans, different classes of lymphocytes are anatomically segregated in such a way that they
interact with one another only when stimulated to do so by encounters with antigens and other
stimuli. Mature lymphocytes that have not encountered antigen are called naïve lymphocytes.
After they are activated by recognition of antigens and other signals lymphocytes differentiate
into effector cells which perform the function of eliminating microbes and memory cells, which
live in a state of heightened awareness and are able to react rapidly and strongly to combat the
microbe in case it returns.
Page | 12
Lymphocytes specific for large number of antigens exist before exposure to antigen,
and when an antigen enters it selectively activates the antigen specific cells. This fundamental
concept is called clonal selection. According to this hypothesis lymphocytes express specific
receptors for antigens and mature into functionally competent cells before exposure to antigen.
Lymphocytes of same antigen specificity are said to constitute a clone. All the members of one
clone express identical antigen receptors, which are different from receptors of all other clones
(11)
.
Antigen receptor diversity is generated by somatic recombination of the genes that en-
code receptor proteins. It is important to note that germ line antigen receptor genes are present
in all cells of the body but only T and B cells contain recombined (also called rearranged)anti-
gen receptor genes( the T- cell receptor[TCR] in T cells and immunoglobulin[Ig]in B
cells).Hence the presence of recombined TCR or Ig genes which can be demonstrated by mo-
lecular analysis is a marker of Tor B lineage cells. Furthermore, because each T or B cells and
its clonal progeny have a unique DNA rearrangement, it is possible to distinguish polyclonal
(non-neoplastic) lymphocytic proliferations from monoclonal (neoplastic) lymphoid tumours.
Thus, analysis of antigen receptor gene rearrangement is a valuable assay for detecting tumours
derived from lymphocytes (11).
T-Lymphocytes
There are three major populations of T cells which serve distinct functions. Helper T lympho-
cytes stimulate B lymphocytes to make antibodies and activate other leukocytes (e.g., phago-
cytes) to destroy microbes; cytotoxic T lymphocytes (CTLs)kill infected cells; and regulatory
T lymphocytes limit immune responses and prevent reactions against self-antigens.
T lymphocytes develop in the thymus from precursors that arise from hematopoietic
stem cells. Mature T cells are found in blood and they constitute about 60-70 % of lymphocytes,
Page | 13
and in T cell zone of peripheral lymphoid organs. Each T cell recognizes a specific antigen by
antigen specific TCR. This TCR consists of α and β polypeptide chains which recognizes pep-
tide antigens that are presented by MHC molecules on the surface of antigen –presenting cells.
CD3, CD4, CD8
Each TCR is noncovalently linked to six polypeptide chains which form the CD3 com-
plex and the ζ chain dimer. They are involved in the transduction of signals into the T cells that
are triggered by binding of antigen to TCR. Together with the TCR these proteins form the
TCR complex (11).
In addition to CD3 and ζ proteins , T cells express several other proteins that assist the
TCR complex in functional response .These includeCD4, CD8, CD 28 and integrins .Approx-
imately 60 % of mature T cells are CD4 + and 30 % are CD8+.Most CD4+ T cells function as
cytokine secreting helper cells that assist macrophages and B lymphocytes to combat infections
.Most CD8+ T cells function as cytotoxic ( killer) T lymphocytes( CTLs ) to destroy host cells
harbouring microbes.CD4 and CD8 serve as co-receptors in T cell activation. During antigen
activation CD4 molecules bind to class II MHC molecules and CD8 molecules bind to class I
MHC molecules and the CD4 and CD8 co receptor initiates signals that are necessary for acti-
vation of T cells. Integrins are adhesion molecules that promote the attachment of T cells to
APCs.
CD4 /CD8 Ratio
The normal CD4/CD8 ratio in healthy hosts is poorly defined. Ratios between 1.5 and
2.5 are generally considered normal; however, a wide heterogeneity exists because sex, age,
ethnicity, genetics, exposures and infections may all impact the ratio. Normal ratios can invert
through isolated apoptotic or targeted cell death of circulating CD4 cells, expansion of CD8
Page | 14
cells, or a combination of both phenomena. Low or inverted CD4/ CD8 ratio is an immune risk
phenotype and is associated with altered immune function, immune senescence and chronic
inflammation in both HIV –infected and uninfected populations (13).
The prevalence of an inverted CD4/CD8 ratio increases with age. An inverted ratio is
seen in 8% of 20-59 – year- olds and in16 % of 60-94- year – olds. Women across all age
groups are less likely to have an inverted ratio than their male counter parts Age and hormone
related atrophy of the thymus is theorized to explain the differences between populations .Hor-
monal influence on the ratio is supported by a correlation between low plasma oestradiol lev-
els, high circulating CD8 and low CD4/CD8 ratio in women with premature ovarian failure.
Psychoneuroimmunology
The Psychoneuroimmunology (PNI) is an emerging field which may serve as a platform
for multidisciplinary collaborations from the areas including psychology, neurobiology, immu-
(14)
nology, endocrinology, pharmacology and toxicology . It is the study of the interactions
between psychological phenomena, the nervous system, and the immune system including es-
pecially psychological effects such as stress on immune response (15). The central nervous sys-
tem, endocrine system and immune system are interconnected through different pathways.
Stressful life events and negative emotions may lead to disruption in the normal functioning of
the interactions between the three important systems. Stress can dysregulate the two types of
adaptive immunity; the humoral immunity and the cellular immunity.
The autonomic nervous system (ANS) and the hypothalamic-pituitary-adrenal axis
(HPA) are two major stress-signaling pathways that contribute to immune dysregulation. The
psychological stress may contribute an imbalance in the immune response among children (16-
17)
. Men with posttraumatic stress disorder (PTSD) were reported with low levels of CD4+,
CD8+, NK cell activity, total amounts of interferon-γ (IFN-γ) and IL-4 (18)
. Post-traumatic
stress disorder may be a risk factor for auto immune disorders among different classes of people
Page | 15
(19-20)
. All these studies reported that, the human immune system is disturbed by various psy-
chopathological conditions. The T-lymphocytes activates the immune response via production
of cytokines and stimulate B cells to produce antibodies and destroys the antigen producing
cells.
Psychological Stress and Immunity
The PNI research reports from animals revealed that, stress can disrupt normal immune
function. Psychosocial stress may impair immune functions and provoke the development of
pathologies among human beings too. Stress can dysregulate humoral and cellular immune
responses. Chronic stress and its correlates contribute to serious immune dysregulation and
thereby adverse health outcomes (21).
Stress is a psychological and physical strain or tension generated by physical, emo-
tional, social, economic, or occupational circumstances, events or experiences that are difficult
(15)
to manage and endure . Post-traumatic stress disorder (PTSD) and anxiety-like behaviours
also dysregulates immune functioning. PTSD is a psychological distress following exposure to
a traumatic or stressful event. Symptoms of psychological distress lasting for more than 1
month is characterised as PTSD. Physical or mental stress leads to neuroplasticity in the brain
and increases the risk of depression and anxiety. Stress exposure causes the dysfunction of
peripheral lymphocytes (22).
In stress-induced mood disorders, severe mitochondrial fission occurs in CD4+ cells,
which in turn leads to a variety of behavioural abnormalities including anxiety, depression and
(22)
social disorders . Following to stress exposure cortisol and catecholamines modulate im-
mune activity, whereas dehydroepiandrosterone (DHEA-secreted by adrenal cortex) may serve
to moderate these immunosuppressive effects.
Page | 16
Homoeopathy and Immunity
Homoeopathy is an alternative system of medicine using ultra-diluted doses of medic-
inal substances. It is based on the similia principle advocated by Hippocrates and scientifically
proved by Samuel Hahnemann. Homoeopathy is well-known in the field of disease prophy-
laxis. It was hypothesised that, the disease prevention in homoeopathy carried out by enhancing
immunity status of the individual. There were many studies reported with immunological stud-
ies with homoeopathy.
Ullman (23) reported that, the homoeopathic medicines made statistically significant pre-
test and post-test values of CD4 among the subjects with stage III AIDS. It also maintained the
values of CD8 count among these patients. Charan, Shinde, Manchanda, Khurana & Taneja (24)
revealed that, in HIV patients the homoeopathic medicines improved the CD4 count and
CD4/CD8 ratio. The homoeopathic drugs in various potencies can influence mice, bone mar-
row cells, macrophages and PMN cells (25). Homoeopathic medicines in very minute material
doses are capable of making biological changes among living organisms. The T-lymphocytes
especially CD4 and CD8 play major role in maintain the immune status of human beings. These
studies showed that, homoeopathic medicines can exert certain changes among immune mech-
anisms.
Bonamin et al., (26) conducted a study and analysed the immune modulation mechanism
of Thymulin 5CH in a granuloma experimental model. The study was conducted among mice
models and reported that, there were increase in the CD4+ and CD8+ T-lymphocytes in the
local lymph node. The study proved that; ultra-diluted substances produce immunomodulating
functions in living organisms.
The human immune functioning is a complex process consisting of various factors. The
mind-body interaction plays an important role in maintaining the immunity. Psychological
Page | 17
stress can dysregulate the immune status. The disaster like COVID-19 can inversely affect the
immune status of individuals. There were studies which help to increase immune profile
through homoeopathy.
Hypotheses
1. There will not be subjective distress among residents of COVID-19 related hot spot
2. There will not be difference in subjective distress among males and females.
3. There will not be difference in subjective distress among various age groups.
4. There will not be absolute CD4 count, absolute CD8 count, absolute CD3 count, abso-
lute lymphocyte count and CD4:CD8 ratio below normal among the residents of
COVID-19 hot spots areas in Pathanamthitta.
5. The homoeopathic medicine Arsenicum album 30C will not upregulate the immuno-
logical markers among residents of COVID-19 related hot spot areas in Pathanamthitta.
Page | 18
CHAPTER THREE
METHODS
Page | 19
The study was conducted in two phases. The phase-1 was an exploratory study done to
find out whether any subjective distress was present among the individuals residing in the hot
spot areas of Pathanamthitta district. The individuals with high levels of subjective distress
may have low immunity status which can increase the chance of getting COVID-19 infection.
The phase-1 of the study explored level of subjective distress among these individuals. Those
individuals residing in the hot spot areas with high subjective distress and low immunity are at
risk of infection. The phase-2 of the study was an experimental phase. It was done to find out
whether the homoeopathic medicine Arsenicum alb was effective for upregulating the immu-
nological markers among these individuals with high levels of subjective distress.
Figure No.3.1
BRIEF OUTLINE OF THE STUDY
Page | 20
PHASE-1
The exploratory part of the study was done to find out whether the residents in the
COVID-19 hotspots were suffering from any kind of stress related issues. It was reported that
disasters are usually associated with higher levels of psychological issues among the people
who involved in it.
Design
The study was conducted using descriptive design. The descriptive designs are usually
employed to study the characteristics of a population. The design was used in the current study
to explore whether there was any psychological distress were present among the residents of
hot spot areas.
Population
The population of the study was residents of COVID-19 hot spot areas in the
Pathanamthitta district of Kerala state. Ranni taluk was reported as high-risk area due to the
presence of COVID-19 infected persons. The population size was 12 lakhs according to the
2011 census.
Participants
The participants were residents of Pathanamthitta who are having subjective distress
resulting from the presence COVID-19 pandemic in the district. The sample size was deter-
mined not less than 385 individuals.
Page | 21
Table No. 3.1
List of Taluks and Panchayaths selected for Data Collection
Sl No Taluk Grama Panchayath

1 Adoor 1 GHD Pandalam
2 GHD Koduman
3 NHMD Kadambanad
2 Thiruvalla 4 GHD Peringara
5 GHD Thottappuzhasseri
6 GHD Kuttappuzha
7 NHMD Niranam
3 Ranni 8 GHD Vadasserikkara
9 GHD Puthusserimala
10 NHMD Perunadu
11 NHMD Ranni Angadi
12 NHMD Cherukol
4 Konni 13 GHD Pramadam
14 GHD Seethathodu
15 NHMD Konni
4 Kozhenchery 16 GHD Kulanada
17 GHD Naranganam
18 GHD Chenneerkkara
19 GHD Elanthoor
20 NHMD Omalloor
5 Mallappally 21 GHD Kottanadu
22 GHD Kallooppara
23 GHD Chungappara
24 NHMD Kunnanthanam
The research team collected data from 1151 participants from 24 Grama Panchayaths
using purposive sampling. The number of participants screened with Single Question Screen-
ing were 120. And from which 61 participants were diagnosed as having subjective distress.
Page | 22
Figure No.3.2
FLOW CHART: SAMPLE SELECTION
Inclusion Criteria:
1. Residents of Pathnamthitta District
2. Age above 20 years
3. Both sexes
Exclusion Criteria:
1. COVID-19 Isolated Patients
2. COVID-19 Related Quarantined Individuals
3. Psychiatric Patients
4. Individuals with Psychological Illnesses.
Page | 23
Tools
The tools used in the Phase-1 of the study are Personal Data Schedule, Single Question
Screening and Impact of Events Scale-Revised.
1. Personal Data Schedule (PDS): It is a format to collect the socio-demographic data
such as name, age, sex, domicile etc from the participants. These data are used for
descriptive analysis. A copy of Personal Data Schedule is attached as Appendix-1.
2. Single Question Screening (SQS): It is a screening question prepared by the author
to check whether the participants are suffering any kind of psychological distress.
The question directly asks the participants whether they had any stress after report-
ing the first case of COVID-19 in the district. If they had answered the question
‘yes’, then only they were taken for further assessment. A copy of the SQS is at-
tached along with Appendix-1.
3. Impact of Events Scale-Revised (IES-R) Malayalam Translation: It is a self-report
measure of current subjective distress in response to a specific traumatic event (27).
The Scale is having 22 items under 3 subscales such as intrusion, avoidance and
hyperarousal. The present study has used the Malayalam translation of the IES-R
which is not standardized. The test-retest reliability is (r = -0.89 to 0.94) and internal
consistency (Chronbach’s α) for each subscale (intrusion=0.87 to 0.97, avoidance=
0.87 to 0.97 and hyperarousal=0.79 to 0.91). A copy of the IES-R is attached as
Appendix 3.
Procedure for Data Collection
There were 6 taluks in the Pathanamthitta district including Mallappally, Thiruvalla,
Ranni, Kozhenchery, Adoor and Konni. The data were collected through Government Homoeo
Dispensaries and National Health Mission Homoeo dispensaries within the district. Such
Page | 24
twenty four dispensaries were randomly selected from the list and 50 participants from each
dispensary were selected for the study. The duty medical officer took the charge of collecting
the data. A total of 1151 participants were recruited from 24 dispensaries. Each participant was
screened using Single Question Screening and 120 participants were selected. After that, the
diagnostic tool, Impact of Events Scale-Revised (IES-R) was given to the 120 participants and
61 participants diagnosed as having IES-R score at or above 24 were recruited as the final
participants
Statistical Analysis
The Phase-1 of the study was an exploratory research and descriptive analysis was used.
The statistical tests used were frequencies, independent ‘t’ test and one-way ANOVA. The
number and percentage of male and female participants were calculated using frequency as-
sessment. The independent ‘t’ test was used to find out whether any difference in IES-R score
existed among males and females. The One-way ANOVA was used to determine the difference
in IES-R score among different age groups.
PHASE-2
The second phase of the study was an experimental research. It was conducted to find
out the efficacy of homoeopathic medicine Arsenicum album 30C for upregulating immune
markers among residents of COVID-19 related hotspots in Pathanamthitta district.
Design:
The study was conducted using a One Group Pre-test/Post-test Design. A pre-test ob-
servation was made before the intervention and post-test was done after the intervention (28).
Page | 25
Table No. 3.2
One Group Before After Design
Group Pre-test Intervention Post-test
Experimental W X Y
Group Immune Markers Arsenicum album 30C Immune Markers
Population
The population of the Phase-2 of the study was the residents of Pathanamthitta district
with COVID-19 related subjective distress. There were 61 participants diagnosed as having
subjective distress due to COVID-19 form 1151 individuals studied.
Participants
The individuals with low immunity profile was selected as the participants of the study.
The low immune profile was identified by those with absolute CD4 count below normal. The
sample size was 16 and the participants were selected using purposive sampling.
Page | 26
Figure No. 3.3
FLOW CHART: SAMPLE SELECTION
Inclusion Criteria:
1. Residing at Pathanamthitta District
2. Both males and females
3. Age above 40 years
4. Female participants with Absolute CD4 Count below 995
5. Male participants with Absolute CD4 Count below 852
Page | 27
Exclusion Criteria:
1. Individuals with Hypertension, Diabetes Mellitus, Cardio-Vascular Diseases,
Chronic Respiratory Diseases, Chronic Liver Diseases, Malignancy, Psychiatric Ill-
ness, Immuno Deficiency due to others diseases.
2. Patients with chronic medication.
3. Individuals under quarantine and isolation.
Figure No. 3.4
Research Team for Data Collection
Page | 28
Tools:
The tools used for data collection in this phase were IES-R and Immunological Markers
including Absolute Lymphocyte Count, Absolute CD3 Count, Absolute CD4 Count and Ab-
solute CD8 Count. The base line for CD4 count was fixed at 995 (29). The IES-R was used for
diagnosing the subjective distress experienced by the residents living at hot spot areas.
1. Immunological Markers: The immunological markers used in the study are absolute
CD4 count, absolute CD8 count, absolute CD3 count, absolute lymphocyte count
and CD4:CD8 ratio. The normal values of the immunological markers are given in
the Table No.3.3
Table No.3.3
Normal Mean Values of Immunological Markers (Indian Population)
SL No Parameters Indian Population Male Female

Mean Mean Mean
1 ALC 2114 (38) 2051(38) 2201(38)
2 CD3 1692 (29) 1769 (29) 1625 (29)
3 CD4 919 (29) 852 (29) 995 (29)
4 CD8 552(38) 568(38) 530(38)
5 CD4:CD8 1.7(38) 1.55(38) 1.92(38)
Intervention Technique:
The homoeopathic medicine Arsenicum album 30C was used as the intervention for
upregulating the immunological markers among individuals with low immune profile as a re-
sult of COVID-19 related subjective distress. The Arsenicum alb 30C is the homoeopathic
medicine prescribed by the Ministry of AYUSH, Government of India. It was hypothesised
that, homoeopathic prophylaxis takes place by upregulating the immunity of the individuals.
Page | 29
Table No.3.4
Details of Intervention Technique
Name of Medicine ARSENICUM ALBUM
Potency 30C
Dosage 1-0-0 for 3 days
Name of Manufacturer Kerala State Homoeopathic Co-Operative
Pharmacy Ltd
Date of Manufacture March 2020
Expiry Date February 2022
Batch No TID 38/1082
Procedure for Data Collection
From the Phase-1 of the study, 61 participants were identified with subjective distress
(IES-R Score above 24). Among these 61 participants, 49 participants were selected as having
age above 40 years. Twenty participants were given consent for the study. The informed con-
sents were signed and collected from them. The aims and objectives of the study were explained
to the participants by the medical officers. The initial blood samples (for pre-test) were col-
lected from them on 4th May, 2020. The blood samples were analysed at Muthoot Health Plus,
Adoor. The homoeopathic medicine Arsenicum alb30C was given to participants on 14th 15th
and 16th May 2020. The final blood samples were taken on 19th May, 2020. The participants
were advised not to take any medicines and therapeutic interventions of any mean without
consulting the medical officer unless in emergency. The pre-test and post-test values were
taken and analysed.
Page | 30
Table No. 3.5
The Date and Time of Collection of Blood Samples
Partici- Pre-Test Post-Test

pants Date Time Date Time
1 04.052020 02.46PM 19.05.2020 03.22PM
2 04.05.2020 02.46PM 19.05.2020 03.21PM
3 O4.05.2020 02.52PM 19.05.2020 03.16PM
4 04.05.2020 02.53PM 19.05.2020 03.18PM
5 04.05.2020 02.44PM 19.05.2020 03.17PM
6 04.05.2020 02.38PM 19.05.2020 03.24PM
7 04.05.2020 02.42PM 19.05.2020 03.21PM
8 04.05.2020 02.43PM 19.05.2020 03.18PM
9 04.05.2020 02.54PM 19.05.2020 03.19PM
10 04.05.2020 02.52PM 19.05.2020 03.19PM
11 04.05.2020 02.53PM 19.05.2020 03.15PM
12 04.05.2020 02.43PM 19.05.2020 03.14PM
13 04.05.2020 02.45PM 19.05.2020 03.21PM
14 04.05.2020 02.42PM 19.05.2020 03.20PM
15 04.05.2020 02.41PM 19.05.2020 03.23PM
16 04.05.2020 02.51PM 19.05.2020 03.16PM
Instructions Given to the Participants
There were 16 participants in the experimental group after entire screening. The fol-
lowing instructions were given to the participants before the oral administration of Arsenicum
album 30C.
1. Stay home, do not go out unless it is inevitable.
2. Eat good diet including vegetables.
3. Sleep 6-8 hours in a day.
4. Do not take any medicine or therapeutic interventions without informing the medi-
cal officer in charge.
5. Inform any discomfort felt while taking Arsenicum album 30C.
Page | 31
Statistical Analysis:
The pre-test values of absolute CD4 count, absolute CD3 count, absolute CD8 count,
absolute lymphocyte count and CD4:CD8 ratio were compared with post-test values. Paired ‘t’
test was used to for statistical analysis. The effects size was analysed using Cohen;s d effect
size method.
Page | 32
CHAPTER FOUR
RESULTS & DISCUSSION
Page | 33
The aim of the study was to find out the efficacy of homoeopathic medicine Arsenicum
alb 30C for upregulating the immunological profile among the residents of COVID-19 related
hot spot areas in Pathanamthitta district of Kerala. The study was performed through two
phases as an exploratory phase (Phase-1) and an experimental phase (Phase-2). The exploratory
study was conducted among the individuals living in the hot spot areas of Pathanamthitta. The
major objective of the study was to find out whether there exist any COVID-19 related subjec-
tive distress among the residents of hot spot areas in Pathanamthitta.
The statistical procedures used in the study were independent ‘t’ test, paired ‘t’ test,
analysis of variance (ANOVA), Cohen’s d for effect size. The independent ‘t’ test was used to
identify whether any difference in IES-R score exist between male and female individuals in
the study. The ANOVA was used to check whether any difference in the IES-R score exist
between various age groups of the participants. The paired ‘t’ test was used to find out the pre-
post difference in the immunological markers observed after the intervention. Cohen’s d test
was used to identify the effect size made in the post test after the intervention.
RESULTS OF THE EXPLORATORY STUDY (PHASE-1)
The exploratory study was done among the residents of COVID-19 related hot spots of
Pathanamthitta district of Kerala state. This phase of the study aimed to find out whether any
subjective distress exists among these people due to the outbreak of COVID-19 pandemic. The
population size of the study was 1200000 within the six taluks of the district. The sample size
obtained was 385 (confidence level as 95%). Getting a clear picture of the situation, 1151 in-
dividuals were recruited to the initial screening from the 24 grama panchayaths. These individ-
uals were administered with a Single Question Screening and 120 individuals were identified
with perceptive distress resulted from the presence of COVID-19 outbreak at their locations.
Page | 34
Again, these 120 individuals were administered with IES-R questionnaire and 61(5.29%) par-
ticipants were identified as having subjective distress due to COVID-19 pandemic.
Classification of Participants
The participants of the study were classified according to sex and age. There were 17
(27.9%) males and 44 (72.1%) females took part in the study. It showed that a greater number
of female participants are subjectively distressed than male participants during the COVID-19
pandemic situation.
Table No. 4.1
Classification of Participants based on Sex
Sl No Socio-Demographic Varia- Group N Percentage

ble
1 Sex Male 17 27.9
Female 44 72.1
(30)
Animani, Elbert, Olema & Hecker reported that war-related trauma and posttrau-
matic stress disorder are more affected in women than men among civilians. Olff (31) found that
women have two to three times higher risk of developing post-traumatic stress disorder com-
pared to men. The lifetime prevalence of PTSD is about 10-12% in women and 5-6% in men.
The present study also confirmed that, women civilians are more affected with PTSD than men.
According to the age, the participants were classified into five groups. The first group
consists of age ranging from 20years to 30 years, the second group consists of age ranging from
31 years to 40 years, third group consists of age ranging from 41 years to 50 years, fourth group
consists of age ranging from 51 to 60 years of age and the fifth group consists of age ranging
from 61 years to 70 years of age. The number of participants in the first group was 3 (4.9%),
Page | 35
in the second group was 16 (26.5%), in the third group was 25 (41%), in the fourth was 10
(16.4%) and in the fifth group was 7 (11.5%).
Table No. 4.2
Classification of Participants on Age Groups
Sl No Socio-Demographic Varia- Group N Percentage

ble
1 Age 20-30 years 3 4.9
31-40 years 16 26.2
41-50 years 25 41
51-60 years 10 16.4
61-70 years 7 11.5
(32)
Reynolds, Pietrzak, Mackenzie, Chou & Sareen reported after a nation wise study
in US that, younger adults (20 -34 years) and middle aged (35-64 years) are more stressed than
older adults (60 years above) due to war. Younger and middle adults had significantly greater
symptom counts than older adults. The present study also showed that, the participants from
younger (20-40 years) and middle aged (41-60 years) are more vulnerable to stress situations
in life. Hence subjective distress produced by the presence of COVID-19 pandemic may give
rise to low immunological functioning especially middle aged and older groups. Younger age
group may have higher level of distress, but they might be healthier than the other two groups.
The clinical significance, number of participants and frequency of the IES-R score of
the participants is given in the Table No. 4.3. There are 19 participants having IES-R score
ranging from 24 to 32. These participants are probability of diagnosing PTSD. Another group
of 12 participants are having IES-R score ranging from 33 to 36 which indicates that, they have
PTSD. There are large group with 30 participants having IES-R score ranging from 37 to 88
are having PTSD which can suppress their immune system (18, 27).
Page | 36
Table No. 4. 3
Clinical Significance of IES-R among the Participants
SlNo IES-R Score N Frequency Clinical Importance

(%)
1 24 to 32 19 31.1 Probable Diagnosis of PTSD
2 33 to 36 12 19.7 PTSD is Clinical Concern
3 37 to 88 30 49.2 PTSD with suppression of
Immune Function
The Table No.4.4 shows the descriptive statistics of the IES-R Scores of the group. The
minimum score of the group was 24 and maximum score was 77. The mean score of the group
was 39.21 and the standard deviation was 11.72.
Table No. 4.4
Mean IES-R Score of the Study Group
IES-R SCORE N Minimum Maximum Mean SD

61 24 77 39.21 11.72
The group mean of the IES-R score lies in between the range of 37 to 88 which indicates
that, the group has high level of subjective distress. Such a subjective distress is resulting from
high level of PTSD which is enough to affect the normal immune functioning.
Page | 37
Analysis of IES-R Score and Sex
The IES-R score of the participants are analysed on the basis of sex and age. The Table
No. 4.5 Shows that, the mean IES-R score of males was 36.41 and standard deviation was 9.67
and that of females was 40.29 and 12.35 respectively.
Table No.4.5
Comparison of IES-R Score on Sex: Results of Independent ‘t’ Test
Varia- Group N Mean SD t-Value

ble
Sex Male 17 36.41 9.67 -1.163ns
Female 44 40.29 12.35
ns-not significant
The t-value of the comparison was -1.163 which is not significant at any levels. The
analysis indicates that, there is no significant difference on IES-R score existing between male
and female participants. There is no group difference observed on the level of IES-R score.
The Figure No.4.1 represents the IES-R score of males and females in the group.
Figure 4.1
Scores of IES-R among Males and Females: Bar Diagram
41 40.29
40
39
IES-R SCORE
38
37 36.41
36
35
34
Male Female
SEX
Page | 38
Females are at higher risk than females for developing post-traumatic stress disorder
(33)
symptoms (PTSS) following an exposure to trauma Women reported higher levels of all
symptoms and the strongest effect sizes were found symptoms of re-experiencing and anxious
and dysphoric arousal. Among individuals with considerable levels of posttraumatic stress
symptoms (PTSS) women reported higher levels of physiological cue activity and exaggerated
startle symptoms (34). These studies reported that, women participants had higher levels of stress
compared to men. The present study reports that, the mean IES-R score of female participants
is 40.29 and male participants is 36.41 which shows that, female participants had higher levels
of subjective distress compared to male participants, but the difference is not statistically sig-
nificant.
Analysis of IES-R Score with Age
The groups of the participants were 20-30 years, 31-40 years, 41-50 years, 51-60 years
and 61-70 years. The study reports that, there were no significant difference among the levels
of IES-R scores among these participants.
Table No. 4.6
IES-R Score, Mean, SD of Age Groups
Sl No Variable Group N Mean SD

1 IES-R Score 20-30 years 3 36.66 10.21
31-40 years 16 39.00 16.80
41-50 years 25 38.16 8.26
51-60 years 10 44.50 12.26
61-70 years 7 37.00 8.52
From the table no 3.6, it is evident that, the mean IES-R score of the 51-60 years group
has highest level and the 20-30 years group has the lowest level. The age risk for COVID-19
is above 60 years and the immunity are compromised with increasing age.
Page | 39
Figure No.4.2
Number, IES-R Score and SD of Participants: Bar Diagram
NUMBER MEAN SD
44.5
38.16
36.66
39
37
25
VALUE
16.8
12.26
10.21
16
8.52
8.26
10
7
3
20-30 31-40 41-50 51-60 61-70

YEARS YEARS YEARS YEARS YEARS
AGE GROUPS
According to the developmental life span, the age ranges from 40 years to 60 is defined
as the middle age adults. The middle age adults have the highest level of IES-R score, which
indicates that they are having highly stressed traumatic conditions.
The age of the participants in the study is above 20 years. The participants were classi-
fied into 5 groups. The comparison of these groups was done using one-way ANOVA. The
analysis of the IES-R score on age is given in the Table No.4.7.
Table No.4.7
Comparison of IES-R Score among Age Groups: Results of ANOVA
Sl Variable Sum of Squares Mean of Squares F-ratio

No Between Within Between Within
Groups Groups Groups Groups
1 IES-R Score 361.7 7886.23 90.42 140.83 0.642ns
Page | 40
The exploratory study (Phase-1) interviews 1151 participants from 24 Grama Pancha-
yaths through 24 homoeopathic dispensaries. Among which 120 participants said to have dis-
tress and 61 participants were diagnosed as having subjective distress. There were 17 male and
44 female participants in the final samples. The exploratory study found that, 61(5.29%) par-
ticipants interviewed showed subjective distress resulting from COVID-19 pandemic. There
are 19 (31.1%) participants with probable diagnosis for PTSD and 12 (19.7%) participants with
PTSD and 30 (49.2%) participants with PTSD capable of suppressing their immunity.
RESULTS OF EXPERIMENTAL STUDY (PHASE-2)
The aim of experimental study (Phase-2) was to find out the efficacy of the homoeo-
pathic medicine Arsenicum album 30C for upregulating the immunological markers among the
residents of COVID-19 related subjective distress. The sample size of the study was16 includ-
ing 5 males and 11 females. The participants were selected using purposive sampling from the
individuals who showed subjective distress in the Phase-1 of the study.
The immunological markers such as absolute lymphocyte count, absolute CD4 count,
absolute CD3 count and absolute CD8 count were analysed among the 16 participants before
intervention. The participants recruited to the experimental study was based on the absolute
CD4 count. The baseline score for CD4 for males was 852 and females was 995. The table no
3.7 shows the absolute CD4 count of the participants in the experimental study.
Page | 41
Table No. 4.8
Age, Sex & Absolute CD4 Count of Participants at Entry Point
Participant Number Sex Age Absolute CD4

1 F 61 565.00
2 F 42 695.00
3 F 44 273.00
4 F 44 486.00
5 F 52 519.00
6 F 43 783.00
7 F 46 566.00
8 F 60 221.00
9 F 49 686.00
10 F 60 687.00
11 M 55 507.00
12 M 42 446.00
13 M 46 470.00
14 M 49 342.00
15 M 47 678.00
16 F 54 968.00
The figure no 3.3 represents the absolute CD4 of the participants in the experimental
study. The highest absolute CD4 count in the group is 968 and lowest absolute CD4 count in
the group is 221.
Figure No.4.3
Absolute CD4 Count of Participants: Bar Diagram
1100 968
Absolute CD4 Count (cells/µL)
1000
900 783
800 695 686 687 678
700 565 566
600 486 519 507
446 470
500
400 342
273
300 221
200
100
0
F F F F F F F F F F M M M M M F
Participants
F F F F F F F F F F M M M M M F
Page | 42
The mean absolute CD4 count of the group is 555.75 and SD is 192.52. There is 11
female participants with CD4 count below 995 and 5 male participants with CD4 below 852.
The mean CD4 count for male is 586.27 and SD is 215.25 that of female is 488.6 and 122.33
respectively.
Table No.4.9
Mean & SD of Absolute CD4 Count of Males, Females and Group
Sl No Independent Variable N Mean SD

1 Male 5 586.27 215.25
2 Female 11 488.6 122.33
3 Group 16 555.75 192.52
The Table No. 4.10 shows the base line characteristics of the group at entry point. The
base line characteristics recorded at the entry point are systolic blood pressure (SBP), diastolic
blood pressure (DBP), pulse rate (PR), height in cms, body weight in kgs, and body mass index
(BMI).
Table No.4.10
Demographic Parameters of the Participants
SL No Variables N Minimum Maximum Mean

1 Age in years 16 42.00 61.00 49.62
2 Systolic BP 16 110.00 140.00 123.12
3 Diastolic BP 16 70.00 92.00 81.75
4 Pulse Rate 16 62.00 86.00 72.56
5 Height in cms 16 153.00 179.00 164.56
6 Weight in kgs 16 58.00 77.00 66.37
7 Body Mass Index (BMI) 16 21.80 29.00 24.57
The Figure No. 4.4 represents the scattered graphical representation of immunological
markers of the participants. The absolute lymphocyte count dots are represented by the brown
Page | 43
dots which lies in the top of the graph. The yellow dots represent the absolute CD8 count which
lies in the bottom of the graph.
Figure No. 4.4
Immunological Markers on Entry Point: Scattered Graph
2500
T-Lymphocyte Count
2000
(Cells/µL)
1500 CD4
1000 CD8
500 CD3
ALC
0
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16
Participants
The final sample size was 16 which includes 11 females and 5 males. The group mean
of CD4 count is 555.75 and SD is 192.52. The group mean is below the 995 which is the Indian
(29)
norm for females. Thakkar suggested that, the absolute CD4 reference mean for Indian
population are 852 for males and 995 for females. The present study has a mean for males as
586.27 and for females as 488.6. Hence, it is clear that the participants in the study are having
absolute CD4 count below normal and are having low immune profile.
Pre-Post Assessment of Absolute CD4 Count
The absolute CD4 count is an important indicator of the immune status of an individual.
The normal range varies with sex, ethnicity and various other factors. The aim of the study was
to find out whether the homoeopathic medicine Arsenicum album 30C is capable of maintain-
ing the normal range of the T-cells (CD4, CD3, CD8) which are responsible for maintaining
the immune status of the participants.
Page | 44
The results of the pre/post assessment are discussed mainly on three headings in each
section. The peripheral lymphocyte count varies with sex of the participant and there is separate
mean has been estimated for males and females in Indian subjects. Hence, the discussion starts
with the details of the group results, followed by discussion of female participants and then
male participants.
The Table No.4.11 shows the results of the pre and post assessments of absolute CD4
count. The pre/post assessment was done using the paired ‘t’ test.
Table No. 4.11
Comparison of Pre and Post Assessment of Absolute CD4 Count: Results of Paired ‘t’
Test
Condition Mean N SD t-Value Effect Size
(Cohen’s – d)
Post-Test 869.68 16 226.61 5.698*** 1.49
Pre-Test 555.75 16 192.52
***p<0.000
The mean CD4 count of the pre-test is 555.75 and SD is 192.52 and that of post-test is
869.68 and 226.61 respectively. The t-value is 5.698 which is significant at 0.000 levels. The
Cohen’s d effect size was, d=1.49 which is large effect.
Page | 45
Figure No. 4.5
Pre/Post Assessment of Absolute CD4 Count: Line Graph
1300
Absolute CD4 Count (Cells/µL)
1200
1100
1000
900
800
700
600
500
400
300
200
100
0
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16
Participants
Pre Test Post Test
The Figure No.4.5 shows the difference in the absolute CD4 count obtained by partici-
pants in the pre and post conditions. It is evident that each participant has benefitted by the oral
administration of Arsenicum alb 30C by increase in the peripheral absolute CD4 count. In the
figure, the orange line represents the post-test values and blue line represents the pre-test val-
ues.
Pre-Post Assessment of Absolute CD4 Count among Female Participants
The absolute CD4 count among females vary from males and the analysis was done
separately among males and females too.
Table No. 4.12
Pre/Post Assessment of Absolute CD4 Count among Female Participants: Results of
Paired ‘t’ Test
Group Mean N SD t-Value Effect Size

(Cohen’s –
d)
Post-Test 958.27 11 192.14 5.073*** 1.88
Pre-Test 586.27 11 215.25
***p<0.000
Page | 46
The mean CD4 count of female participants in the pre-test condition is 586.27 and SD
is 215.25. The mean CD4 count in the post test condition is 958.27 and SD is 192.14. The t-
value of the paired ‘t’ test is 5.073 which is significant at 0.000 levels. The Cohen’s d effect
size is, d=1.88 which is large effect.
Figure No. 4.6
Pre/Post Assessment of Absolute CD4 Count among Female Participants: Line Graph
1300
1200
1100
1000
900
800
700
600
500
400
300
200
100
0
1 2 3 4 5 6 7 8 9 10 11
Female Participants
Pre Test Post Test
The Figure No.4.6 shows the values of the absolute CD4 count among the female par-
ticipants in pre and post conditions. The blue line represents the pre-test values and the orange
line represents the post-test values. The graph clearly shows that, the absolute CD4 count in-
creased significantly in the post-test conditions.
Pre-Post Assessment of Absolute CD4 Count among Male Participants
The absolute CD4 count among male participants was also analysed. The Table No.4.13
shows the mean values and standard deviation of male participants in the pre and post-test
conditions. The mean absolute CD4 count of the male participants in the pre-test is 674.8 and
SD is 176.69 and that of post-test is 488.6 and 122.33 respectively. The t-value of the compar-
ison is 6.140 which is significant at 0.000 levels. The Cohen’s d effect size is d=1.22 which is
large effect.
Page | 47
Table No. 4.13
Pre/Post Assessment of Absolute CD4 Count among Male Participants: Results of
Paired ‘t’ Test.

(Cohen’s –
d)
Post-Test 674.8 5 176.69 6.140*** 1.22
Pre-Test 488.6 5 122.33
***p<0.000
The Figure No.3.4 shows the graphic representation of the pre and post assessment of
the male participants after the intervention. The absolute CD4 count of all the male participants
improved significantly.
Figure No. 4.7
Pre/Post Assessment of Absolute CD4 Count among Male Participants: Line Graph
2500
2000
1500
1000
500
0
1 2 3 4 5
Male Participants
Pre Test Post Test
Page | 48
The CD4+ T Lymphocytes play a central regulatory role in the immune response. Its
diminution can cause compromises in the defence mechanisms of human body due to defective
immune function. The number of CD4+ T cells circulation provides important information
(29)
about the immune competence of an individual The immunophenotyping of CD4+T cells
helps for monitoring several diseases like HIV infection, and diagnosis of immunodeficiency
(35)
disorders . Physical or mental stress lead to neuroplasticity in the brain. Stress exposure
causes the dysfunction of peripheral T lymphocytes (22). The COVID-19 pandemic is a biolog-
ical disaster which causes subjective distress among individuals who lives in the hot spot areas.
The subjective distress might have caused defects in the immune system which is evident
through the diminished values of CD4 and CD8 lymphocytes.
The mean CD4 count of the group was 555.75 cells/µL which is very low when com-
pared with the Indian standards which is estimated as 919 (±312) cells/µL. It was assumed that,
the homoeopathic medicine Arsenicum album 30C is capable of maintaining the peripheral T-
lymphocyte values such as CD4, CD3 and CD8. The upregulation of the T-lymphocytes en-
hances the immune status of the individuals. The Figure No. 4.8 shows that, the Arsenicum alb
30 C has made significant statistical difference among the pre and post assessments of the CD4
count. The absolute CD4 count has been increased to 869.68 cells/µL. The effect size of the
improvement in the absolute CD4 count is large (Cohen’s d=1.49). In other words, the homoe-
opathic medicine Arsenicum album 30C is effective for upregulating the absolute CD4 count
among residents of COVID-19 related hot spots.
Page | 49
Figure No. 4.8
Mean Values of CD4 Count - Pre-Test, Post-Test and Indian Population:
Bar Diagram
COMPARISON OF ABSOLUTE CD4 COUNT OF PRE -

TEST&POST-TEST VALUES WITH NORMAL
Mean Absolute CD4 Count
POPULATION MEANS
869.68
919
555.75
PRE TEST POST TEST POPULATION
Homoeopathic medicines are used in many medical conditions associated with immu-
nological imbalance. Ullman (23) reported that, the homoeopathic medicines made statistically
significant pre-test and post-test values of CD4 among the subjects with stage III AIDS. It also
maintained the values of CD8 count among these patients. Charan, Shinde, Manchanda,
Khurana & Taneja (24) revealed that, in HIV patients the homoeopathic medicines improved the
CD4 count and CD4/CD8 ratio. The homoeopathic drugs in various potencies can influence
(25)
mice, bone marrow cells, macrophages and PMN cells . Homoeopathic medicines in very
minute material doses are capable of making biological changes among living organisms. The
T-lymphocytes especially CD4 and CD8 play major role in maintain the immune status of hu-
man beings. These studies showed that, homoeopathic medicines can exert certain changes
among immune mechanisms.
The present study shows that, Arsenicum album 30C potency has made immunomodu-
latory actions among human participants. It was found that, the COVID-19 pandemic has cre-
ated high level of subjective distress among the residents of hot spot areas. The high level of
Page | 50
subjective distress causes alterations in the immune status. It was proved that, homoeopathic
medicine selected on the basis of ‘symptom-similarity’ can be used as a prophylactic medicine
(genus epidemicus) for further spreading (secondary level) of an epidemic disease. The genus
epidemicus prevents further spreading of the disease by maintaining the immunity of the indi-
viduals in a population. In a way, the genus epidemicus acts as an immune booster and main-
tain the immune status capable of preventing the incidence of the epidemic in the population
at risk.
Pre-Post Assessment of Absolute CD8 Count
The absolute CD8 count is another variable examined in the study. The CD8 lympho-
cytes are one among the major cells of the peripheral T-lymphocytes. The number of circulating
CD8 cells is crucial for diagnosis and prognosis of many illnesses.
Table No. 4.14
Comparison of Pre and Post Assessment of Absolute CD8 Count: Results of Paired
‘t’ Test

(Cohen’s – d)
Post-Test 608.62 16 198.47 5.206*** 1.04
Pre-Test 426.56 16 145.40
***p<0.000
The Table No. 4.14 shows the results obtained after paired ‘t’ test. The mean absolute
CD8 count of the group in the pre-test is 426.4 and standard deviation is 145. The post-test
values of mean absolute CD8 count and standard deviation are 608.56 and 198.47 respectively.
The t-value of the comparison is 5.206 which is significant at 0.000 levels. The Cohen’s d
effect size is 1.04 which is large effect size.
Page | 51
Figure No. 4.9
1200
1100
1000
900
800
700
600
500
400
300
200
100
0
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16
Participants
Pre Test Post Test
The Figure No.4.9 shows the graphical representation of the pre/post assessment of the
absolute CD8 count of the group. The blue line represents the pre-test values and orange line
represents the post-test values. All the participants have improved except the case number 10.
Pre-Post Assessment of Absolute CD8 Count among Females
The normal range of CD8 T-lymphocytes exhibit sex differences. The normal range
of CD8 lymphocytes varies with that of males. The normal range is slightly higher among fe-
males. The pre-post assessment has been done separately for females and males.
Table No. 4.15
Comparison of Pre and Post Assessment of Absolute CD8 Count among Female Partici-
pants: Results of Paired ‘t’ Test

(Cohen’s – d)
Post-Test 606.00 11 181.30 4.166*** 1.24
Pre-Test 406.09 11 135.42
***p<0.000
Page | 52
The Table No. 4.15 shows the results of the paired ‘t’ test of the female participants in
the group. The mean absolute CD8 count and standard deviations of the pre-test are 406.09 and
606.00 respectively. The post-test values of mean absolute CD8 is 606.00 and standard devia-
tion is 181.30. The t-value of the comparison is 4.166 which is significant at 0.000 levels. The
Cohen’s d effect size is 1.24 which is large.
Figure No. 4.10
Pre/Post Assessment of Absolute CD8 Count among Feale Participants: Line Graph
1200
1100
Absolute CD8 Count
1000
900
800
700
600
500
400
300
200
100
0
1 2 3 4 5 6 7 8 9 10 11
Female Participants
Pre Test Post Test
The Figure No. 4.10 shows the graphical representation of the pre-post assessment of
the absolute CD8 cells of the female participants in the study. The blue line represnts the pre-
test values and the orange line represnts the post-test values.
Pre-Post Assessment of Absolute CD8 Count among Males
The pre-post assessment of absolute CD8 count has been conducted among male par-
ticipants to find out whether there is any difference in the mean values. The comparison was
done using paired ‘t’ test. The effect size of the difference was also calculated using Cohen’s
d effect size.
Page | 53
Table No. 4.16
Comparison of Pre and Post Assessment of Absolute CD8 Count among Male Partici-
pants: Results of Paired ‘t’ Test.

(Cohen’s –
d)
Post-Test 614.40 5 255.87 3.749* 0.65
Pre-Test 471.60 5 172.46
*p<0.05 level
The Table No. 4.16 shows the results of the paired ‘t’ test among male participants. The
mean absolute CD8 count of male participants in the pre-test condition is 471.60 and standard
deviation is 172.46. The absolute CD8 count in the post-test is 614.40 and standard deviation
is 255.87. The t-value of the comparison is 3.749 which is significant at 0.05 level. The Cohen’s
d effect size is 0.65 which is moderate.
Figure No. 4.11
1000
900
800
700
600
500
400
300
200
100
0
1 2 3 4 5
Male Participants
Pre Test Post Test
Page | 54
The Figure No.4.11 shows the graphical representation of the male participants. The
blue line represents the values of absolute CD8 count in the pre-test and orange line represents
the values in the post-test condition. The graph clearly reveals changes made in the study.
The CD8+ Cytotoxic T-lymphocytes (CTLs) play a central role in the adaptive immune
functioning of the body. These cells function in response to intracellular infections, in which
their role is to kill infected cells (36). The CD8+ T cells are thought to be important for control-
ling primary viremia in case of HIV infection. Hence, the number of CD8+ T lymphocytes in
the circulating blood is important for maintaining immune status of an individual. The absolute
CD8 count may alter with sex and age. It was reported that, females are somewhat stronger
immune responses than males (37)
Bonamin et al., (26) conducted a study analysed the immune modulation mechanism of
Thymulin 5CH in a granuloma experimental model. The study was conducted among mice
models and reported that, there were increase in the CD4+ and CD8+ T-lymphocytes in the
local lymph node. The study proved that; ultra-diluted substances produce immunomodulating
functions in living organisms.
The CD8+ T-lymphocyte count is diminished among the residents of COVI-19 related
hot spots areas. This condition may give rise to lowered immunity among these individuals and
opens the chance of getting various infections. The mean initial absolute CD8 count of the
(38)
participants is 426.65 cells/µL which below the normal value as 552 cells/µL . After the
intervention with Arsenicum alb 30C the mean absolute CD8 count has increased to 608.62
cells/µL.
Page | 55
Figure No. 4.12
Mean Values of CD8 Count -Pre-Test, Post-Test and Indian Population: Bar Di-
agram
COMPARISON OF MEAN ABSOLUTE CD8 COUNT OF PRE -

TEST&POST-TEST VALUES WITH NORMAL POPULATION MEAN
Mean Absolute CD8 Count (Cells/µL)
608.62
552
426.56
The CD8+ of male and female participants also done separately. The absolute CD8+T-
lymphocyte count significantly increased among female and male participants. The mean ab-
solute CD8 count of female participants was 406.09 cells/µL initially, which increased to
606.00 cells/µL. The mean absolute count of male participants was 471.6 cells/µL initially
which raised to 614.4 cells/µL. The effect size of the improvement is large (Cohen’s d=1.04).
From the results it is quite evident that, the CD8+ T-lymphocytes which are very essential for
maintaining the adaptive immunity of an individual has significantly increased in absolute
count after the oral administration of the homoeopathic medicine Arsenicum album 30C.
Pre-post Assessment of Absolute CD3 Count
The CD3 are cells associated with the activation of T cell effector functions. The abso-
lute CD3 count within the normal range is essential for these activities. The table No.4.18
shows the results of the paired ‘t’ test of the comparison of the pre and post assessment. The
Page | 56
mean absolute CD3 count and standard deviation of the group in the pre-test condition are
1016.43 and 300.28 respectively. In the post-test the mean absolute CD3 count is 1535.25 and
standard deviation is 334.63. The t-value of the comparison is 5.987 which is significant at
0.000 levels. The Cohen’s d effect size is 1.63 which is large effect.
Table No.4.17
Comparison of Pre and Post Assessment of Absolute CD3 Count: Results of the Paired
‘t’ Test.
Condition Mean N SD t-Value Effect Size

(Cohen’s – d)
Post-Test 1535.25 16 334.63 5.987*** 1.63
Pre-Test 1016.43 16 300.28
***p<0.000
The Figure No.4.13 shows the graphical representation of the pre/post assessment of
the participants. The blue line represents the values of the absolute CD3 count in the pre-test
and the orange line represents the values in the post-test.
Figure No. 4.13
2500
2250
2000
1750
1500
1250
1000
750
500
250
0
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16
Participants
Pre Test Post Test
Page | 57
Pre-Post Assessment of Absolute CD3 Count among Females
Since there are sex differences in the values of absolute CD3 count, the pre-post assess-
ment has conducted among females and males separately. The Table No.4.18 shows the results
of the paired ‘t’ test of the comparison between pre and post conditions. The mean absolute
CD3 count of female participants in the pre-test condition is 1028.27 and standard deviation is
338.27. The mean absolute CD3 count and standard deviation in the post-test is 1627.18 and
295.89 respectively. The t-value of the comparison is 5.127 which is significant at 0.000 levels.
The Cohen’s d effect size is 1.88, which is large.
Table No.4.18
Comparison of Pre and Post Assessment of Absolute CD3 Count among Female Partici-
pants: Results of the Paired ‘t’ Test

(Cohen’s –
d)
Post-Test 1627.18 11 295.89 5.127*** 1.88
Pre-Test 1028.27 11 338.75
***p<0.000
The Figure No.4.14 shows the graphical representation of the pre-post comparison of
female participants in the study. The blue line represents the values of the participants in the
pre-test and orange line represents the values of the participants in the post-test.
Page | 58
Figure No. 4.14
Pre/Post Assessment of Absolute CD3 Count among Female Participants: Line Graph
2500
2000
1500
1000
500
0
1 2 3 4 5 6 7 8 9 10 11
Female Participants
Pre Test Post Test
Pre-Post Assessment of Absolute CD3 Count among Males
The comparison of absolute CD3 count in the pre and post conditions of male partici-
pants were done using paired ‘t’ test. The Table No. 4.19 shows the results of the paired ‘t’
test. The mean absolute CD3 count of male participants in the pre-test is 990.40 and the stand-
ard deviation is 223.66. In the post-test condition, the mean absolute CD3 count is 1333.00 and
standard deviation is 355.88. The t-value of the comparison is 5.577 which is significant at
0.000 levels. The Cohen’s d effect size of the comparison is 1.15 which is large effect.
Page | 59
Table No. 4.19
Comparison of Pre and Post Assessment of Absolute CD4 Count among Male Partici-
pants: Results of Paired ‘t’ Test

(Cohen’s – d)
Post-Test 1333.00 5 355.88 5.577*** 1.15
Pre-Test 990.40 5 223.66
***p<0.000
The Figure No.4.15 shows the pre-post assessment of the absolute CD3 count of male
participants after the intervention. The blue line represents the values of absolute CD3 count
before the intervention and orange line represents the values after intervention.
Figure No. 4.15
1800
1600
1400
1200
1000
800
600
400
200
0
1 2 3 4 5
Male Participants
Pre Test Post Test
The CD3 lymphocytes are a protein complex and T-Cell co receptor essential for T-
Cell Receptor (TCR) activation. The CD3ζ chain is an integral part of the signaling pathway
Page | 60
involved in TCR signaling and its downregulation has been reported with impairment of im-
(39)
mune responses including reduced cell proliferation and cytokine production . Reduced
number of CD3 cells in the peripheral blood may cause declined activation of T-Cell Receptor
and thereby reduction in CD4 and CD8 cells.
The mean absolute CD3 count of the participants in the pre-test is 1016.43 cells/µL and
the post-test is 1535.25 cells/µL. The normal mean of the Indian population is 1692 (±548)
cell/µL (Thakar, 2011). The effect size of the improvement is large (Cohen’s d =1.63). So, it
is very clear that the mean absolute CD3 count is improved significantly from pre-test condition
to post-test condition.
Figure No. 4.16
Mean Values of CD3 Count- Pre-Test, Post-Test and Indian Population: Bar Di-
agram
COMPARISON OF MEAN ABSOLUTE CD3 COUNT OF PRE -

TEST&POST-TEST VALUES WITH NORMAL POPULATION MEAN
Mean Absolute CD3 Count (Cells/µL)
1535.25
1692
1016.43
The Figure No.3.7 represents the difference in mean absolute CD3 count produced after
the oral administration of Arsenicum album 30C. The blue coloured bar represents the pre-test
Page | 61
value, orange colour represents the post-test value of mean absolute CD3 count. The green bar
is the normal population mean of the India.
Pre-Post Assessment of Absolute Lymphocyte Count
The T-lymphocytes are integral part of the adaptive immune system of the body. The t-
(11)
lymphocytes are responsible for the cellular immunity . The absolute lymphocyte count of
the peripheral blood circulation is an important indicator of adaptive immune status of the in-
dividual.
The Table No. 4.20 shows the results of the paired ‘t’ test conducted on the pre-test and
post-test scores of absolute lymphocyte count. The mean absolute lymphocyte count of the
participants in the pre-test is 1411.25 and standard deviation is 382.25. In the post-test the mean
absolute lymphocyte count is 2242.29 and standard deviation is 454.29. The t-value of the
comparison is 6.544 which is significant at 0.000 levels. The Cohen’s d effect size of the com-
parison is 1.98 which is large effect.
Table No. 4.20
Comparison of Pre and Post Assessment of Absolute Lymphocyte Count: Results of
Paired ‘t’ Test.

(Cohen’s – d)
Post-Test 2242.81 16 454.29 6.544 1.98
Pre-Test 1411.25 16 382.25
***p<0.000
The Figure No.4.17 shows the graphical representation of pre-post assessment of abso-
lute lymphocyte count. The blue line represents the values of absolute lymphocyte count in the
pre-test condition and orange line represents the values in the post-test.
Page | 62
Figure No. 4.17
Pre/Post Assessment of Absolute Lymphocyte Count: Line Graph
4000
Absolute Lymphocyte Count
3500
3000
2500
(Cells/µL)
2000
1500
1000
500
0
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16
Participants
Pre Test Post Test
Pre-Post Assessment of Absolute Lymphocyte Count among Female Participants
The normal reference range of the peripheral lymphocyte count is slightly higher among
males compared to females. The Table No.4.21 shows the results of the comparison of pre and
post-tests of absolute lymphocytes among the female participants. The mean absolute lympho-
cyte count of the pre-test condition is 1410.27 and the standard deviation is 448.11. The mean
absolute lymphocyte count and standard deviation of the post-test is 2354.27 and 442.91 re-
spectively. The t-value of the comparison is 5.539 which is significant at 0.000 levels. The
Cohen’s d effect size is 2.11 which is large effect.
Table No. 4.21
Comparison of Pre and Post Assessment of Absolute Lymphocyte Count among Female
Participants: Results of Paired ‘t’ Test

(Cohen’s – d)
Post-Test 2354.27 11 442.91 5.539*** 2.11
Pre-Test 1410.27 11 448.11
***p<0.000
Page | 63
The Figure No. 4.18 shows the graphical representation of the comparison. The blue
line shows the values of absolute lymphocyte count of the female participants in the pre-test
condition. The orange line shows the values in the post-test condition.
Figure No. 4.18
Pre/Post Assessment of Absolute Lymphocyte Count among Female Participants: Line
Graph
4000
Absolute Lymphocyte Count (Cells/µL)
3500
3000
2500
2000
1500
1000
500
0
1 2 3 4 5 6 7 8 9 10 11
Participants
Pre Test Post Test
Pre-Post Assessment of Absolute Lymphocyte Count among Male Participants

The Table No.4.22 shows the results of paired ‘t’ test done to evaluate the pre-post
comparison of the mean absolute lymphocyte count among the participants. The mean absolute
lymphocyte count of the pre-test is 1413.10 and the standard deviation is 214.29. In the post-
test the mean absolute count is 1997.60 and the standard deviation is 417.35. The t-value of the
comparison is 5.378 which is significant at 0.000 levels. The Cohen’s d effect size is 1.76
which is large effect.
Page | 64
Table No.4.22
Comparison of Pre and Post Assessment of Absolute Lymphocyte Count among Male
Participants

(Cohen’s – d)
Post-Test 1997.60 5 417.35 5.381** 1.76
Pre-Test 1413.40 5 214.29
**p<0.01
The Figure No.4.19 shows the graphical representation of the pre-post comparison of
the absolute lymphocyte count of male participants. The blue line represents the values of the
absolute lymphocyte count of the male participants in the pre-test and the orange line represents
the absolute lymphocyte count in the post-test.
Figure No. 4.19
Pre/Post Assessment of Absolute Lymphocyte Count among Males: Line Graph
2500
Absolute Lymphocyte Count
2000
1500
(Cells/µL)
1000
500
0
1 2 3 4 5
Male Participants
Pre Test Post Test
The lymphocytes are a class of white blood cells that consists of small and large lym-
phocytes. The small lymphocytes bear variable cell-surface receptors for antigen and are re-
sponsible for adaptive immune responses. There are two main classes of small lymphocytes-
B-lymphocyte (B-cells) and T lymphocytes (T-cells)(40). The T lymphocytes can be segregated
Page | 65
into two subgroups on the basis of the function and recognition of HLA molecules. These are
designated CD4+ and CD8+ cells. The absolute lymphocyte count is the number of lympho-
cytes among the total white blood cells or it is the relative number of lymphocytes among the
total leukocyte count. The absolute lymphocyte count (ALC) provides an idea about the im-
mune status of an individual.
The interventions directed to upregulate the immunological markers are having key
importance while battling with deadly epidemics. The T lymphocytes are the frontline fighters
who acts at the earliest. Reduced lymphocyte count in the peripheral blood cause low immune
functioning of the body. The homoeopathic medicine Arsenicum album 30C was given to par-
ticipants with low immune profile, like reduced absolute lymphocyte count.
Figure No. 4.20
Mean Values Absolute Lymphocyte Count- of Pre-Test, Post-Test and Indian
Population: Bar Diagram
COMPARISON OF MEAN ABSOLUTE LYMPHOCYTE COUNT OF

PRE-TEST&POST-TEST VALUES WITH NORMAL POPULATION
MEAN
Mean Absolute Lymphocyte Count
2242.81
2114
1411.25
The Figure No. 4.20 shows the graphical representation of the mean absolute lympho-
cyte count of the participants in the pre-test, post-test and the normal Indian population mean.
The mean absolute lymphocyte in the pre-test is 1411.25 cells/µL and that in the post-test is
2242.81 cells/µL. The normal Indian mean is 2114 cells/µL. It shows that, the low absolute
Page | 66
lymphocyte count has been improved significantly after homoeopathic intervention with Arse-
nicum album 30C. The effect size of the improvement is large (Cohen’s d=1.98).
A conducted a review on the efficacy of homoeopathic treatment on AIDS or HIV +
patients. Two RCTs were reviewed and one study reported with positive findings. The study
reported that, there were physical, immunologic, neurological, metabolic and quality of life
benefits, including improvement in lymphocyte count and functions (23). The present study also
confirmed that, absolute lymphocyte count is significantly increased after homoeopathic inter-
vention. Significant difference is also found among male and female participants too.
Pre-Post Assessment of CD4:CD8 Ratio
The CD4:CD8 ratio is an important indicator of the immune status of the body. It is a
prognostic marker in many disease conditions. The Table No. 4.23 shows the results of the
paired ‘t’ test carried out on CD4:CD8 ratio of the participants. The mean CD4:CD8 ratio in
the pre-test is 1.355 and the standard deviation is 0.3968. In the post-test, the mean CD4:CD8
ratio is 1.5075 and standard deviation is 0.44649 respectively. The t-value of the comparison
is 3.039 which is significant at 0.01 level. The Cohen’s d effect size of the comparison is 0.36
which is small effect.
Table No.4.23
Comparison of Pre and Post Assessment of CD4:CD8 Ratio: Results of Paired ‘t’ Test

(Cohen’s – d)
Post-Test 1.5075 16 0.44649 3.039 0.36
Pre-Test 1.3550 16 0.39680
**p<0.01
Page | 67
The Figure No.4.20 explains the graphical representation of the pre-post assessment of
CD4:CD8 ratio of the participants. The blue line represents the CD4:CD8 ratio in the pre-test
and the orange line represents CD4:CD8 ratio in the post test.
Figure No. 4.21
Pre/Post Assessment of CD4:CD8 Ratio: Line Graph
2.5
2
CD4:CD8 Ratio
1.5
0.5
0
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16
Participants
Pre Test Post Test
Pre-Post Assessment of CD4:CD8 Ratio of Female Participants
The CD4:CD8 ratio varies with several factors sex, age, ethnicity and habits. The ratio
is slightly higher among females (38). The Table No. 4.24 shows the results of the paired t’ test.
The mean CD4:CD8 ratio of female participants in the pre-test is 1.4564 and the standard de-
viation is 0.33774. The values in the post-test are 1.6391 and 0.39412 respectively. The t-value
of the comparison is 2.577 which is significant 0.05 level. The Cohen’s d effect size is 0.49
which is small effect.
Table No. 4.24
Page | 68
Comparison of Pre and Post Assessment of CD4:CD8 Ratio among Females: Results of
Paired ‘t’ Test

(Cohen’s – d)
Post-Test 1.6391 11 0.39412 2.577 0.49
Pre-Test 1.4564 11 0.33774
*p<0.05
The Figure No 4.22 shows the graphical representation of the pre-post comparison of
CD4:CD8 ratio of female participants. The blue line represents the values of CD4:CD8 ratio
of female participants in the pre-test and the orange line represents the values in the post-test.
Figure No. 4.22
Pre/Post Assessment of CD4/CD8 Ratio among Female Participants: Line Graph
2.5
2
CD4:CD8 Ratio
1.5
0.5
0
1 2 3 4 5 6 7 8 9 10 11
Female Participants
Pre Test Post Test
Pre-Post Assessment of CD4:CD8 Ratio of Male Participants
The Table No.4.25 shows the results of paired ‘t’ test of males. The mean CD4:CD8
ratio of male participants in the pre-test is 1.144 and the standard deviation is 0.47003. The
values of mean and standard deviation in the post-test are 1.218 and 0.45483 respectively. The
t-value of the comparison is 2.381 which is not significant.
Page | 69
Table No. 4.25
Comparison of Pre and Post Assessment of CD4:CD8 Ratio among Males: Results of
Paired ‘t’ Test
Group Mean N SD t-Value
Post-Test 1.218 5 0.45483 2.381ns

Pre-Test 1.144 5 0.47003
ns-not significant
The CD4 and CD8 ration is an important biomarker for disease progression. It is a more
accurate indicator about the overall immune function. The normal CD4:CD8 ratio between 1.5
to 2.5 is considered as normal (13). Among Indian population the normal ratio is considered as
(38)
1.7 . In patients with HIV infection persistent CD4:CD8 inversion can involve incomplete
CD4 count recovery or persistently high CD8 count. The present study has analyzed the
CD4:CD8 ratio among the participants after homoeopathic intervention. The CD4:CD8 ratio
of female and male participants in the pre-test and post-test conditions are also studied.
The study found that, the oral administration homoeopathic medicine Arsenicum alb
30C has significantly improved the mean CD4:CD8 ratio of the participants in the pre-test and
post-test conditions. The Figure No.4.23 shows the graphical representation of the mean values
of pre-test, post-test and the population normal. The mean CD4:CD8 ratio in the pre-test is 1.35
which is lower than the population mean 1.7. After the intervention the mean value has in-
creased to 1.5 in the post-test. Both the absolute CD4 count and absolute CD8 count improved
after intervention, and that is why the ratio increased. The effect size of the improvement is
small (Cohen’s d=0.36).
Page | 70
Table No. 4.23
Mean Values of Pre-Test, Post-Test and Indian Population: Bar Diagram
COMPARISON OF CD4:CD8 RATIO OF PRE-TEST&POST-TEST

VALUES WITH NORMAL POPULATION MEAN
1.7
1.5
1.35
CD4:CD8 Ratio
The CD4:CD8 ratio differ among females and males. The ratio is 1.14 in males and
1.63 among females before intervention and the ratio increased to 1.21 and 1.63 among males
and females respectively. The improvement of CD4:CD8 ratio is significant among female
participants (p<0.05) and no statistically significant improvement has observed among males,
but an improvement in values observed.
Psychoneuroimmunology and Homeopathy
The present study was conducted strictly on the theoretical aspects two scientific disci-
pline; psychoneuroimmunology (PNI) and homoeopathy. The exploratory phase (Phase-1) of
the study was psychoneuroimmunological aspect, while the experimental phase (Phase-2) was
based on homoeopathy. The aim of the study was to find out the efficacy of the homoeopathic
medicine Arsenicum album 30C for upregulating the immunological markers of residents at
COVID-19 related hot spots in Pathanamthitta. To get an answer to the problem, it was essen-
tial to know two points. (1) Whether subjective distress of any level was developed among
Page | 71
residents of COVID-19 related hot spots areas, (2) Whether low immune markers were associ-
ated with these distressed residents of COVID-19 related hot spots.
The pandemics are generally considered as biological disasters which causes psycho-
logical stress among the affected individuals. The COVID-19 as a pandemic created psycho-
logical stress among 5.29% population studied. Sixty-one participants among 1151 interviewed
(27)
were reported with subjective distress where PTSD as a clinical concern . The subjective
distress was diagnosed using Impact of Events Scale-Revised (IES-R) Malayalam translation.
Among the 61 participants 20 participants were recruited after several screening procedures.
The immunological markers such as absolute CD4 count, absolute CD3 count, absolute CD8
count, absolute lymphocyte count and CD4:CD8 ratio were analysed using Flowcytometry.
Sixteen (80%) individuals were identified as having low immune markers below the normal
Indian population mean.
The Phase-1 of the study revealed that, the COVID-19 pandemic has developed sub-
jective distress among 5.2% individuals of 1151 interviewed. It was also found that, low im-
mune status was identified among individuals having high subjective distress. The COVID-19
developed subjective distress and thereby lowered immunity among the residents of hot spot
areas. The individuals with low immune profile may have high risk of getting diseases. The
interventions to improve the immune profile of the individuals may help to prevent infecting
diseases. It was hypothesised that, homoeopathic medicine Arsenicum album30C is beneficial
for improving the immune profile. The Phase-2 of the study was aimed to find out the efficacy
of Arsenicum album 30C.
Epidemic Prophylaxis
Homoeopathic medicines are ultra-high diluted (potentized) drugs for the treatment of
diseases. The disease producing ability of these potentized drugs are used for disease curing.
Page | 72
The symptoms of an individual are given priority for medicine selection. When a communica-
ble disease (epidemic) appears in a community, it shows mostly common symptom picture
among different individuals. In such cases, a single homoeopathic medicine can be selected on
the basis of the common symptom picture for preventing further spreading of the disease which
is known as Genus Epidemicus (GE). The GE is a homoeopathic medicine developed after
repertorization of the homoeopathic working case definition constructed from a defined popu-
(41) (41)
lation for secondary level prevention of a communicable disease . The HATS Method
can be employed for scientific development of GE.
The COVID-19 is a highly potent communicable disease with reproducibility rate as
2.28 (4). The prevention of COVID-19 is currently taking place through the ‘BREAKING THE
CHAIN’ campaign. The important activities of BREAKING THE CHAIN are frequent hand
washing, using face masks and social distancing. No preventive vaccinations or medicines in
modern medicine is available till the date for prevention of COVID-19 pandemic. But in ho-
moeopathy, medicines are available as GE for prevention of communicable diseases. For
COVID-19 pandemic, the homoepathic medicine Arsenicum album 30C has been identified as
GE by the AYUSH Ministry and was advised for widespread usage. The present study as a
preliminary step, using a Quasi Experimental design undoubtedly proved that, Arsenicum al-
bum 30C is capable of upregulating the immunological markers. The oral administration of
Arsenicum album 30C will be helpful for all individuals for maintaining adaptive immunity
against communicable diseases, especially in the present COVID-19 scenario in the state.
Hypothetical Proposition on Modus Operandi of Arsenicum album 30C.
The modus operandi of homoeopathic medicine is not completely revealed. The action
of Arsenicum album 30C is also not different. An extensive review on the subject explains a
Page | 73
hypothesis. Arsenicum album. is a well-established drug for clinical management of diseases
with presenting symptoms similar to COVID-19. As2O3 is widely used in modern medicine as
well as nanomedicine trials for improving immunity and reduce inflammation caused by im-
munocompromised diseases (42-52). In homoeopathic pharmacopeia of India, the preparation of
Arsenicum album. is reported and approved by CDSCO. Arsenicum album 30C is considered
as an established drug derived from mineral sources which can deliver therapeutic action at
nanomaterial doses (52-57).
More importantly As2O3 and its various formulations have a significant role in PML
isoforms and these PML gene regulations have crucial role in generating antiviral defense
(54)
mechanism . In the context of COVID-19 pandemic outbreak, As2O3 based homoeopathic
prophylaxis will help the human body to experience an immunological learning from artificial
immune challenge raised through Arsenicum album. Glycerin present in Arsenicum album. el-
evates the blood plasma osmolality thereby extracting water from tissues into interstitial fluid
and plasma, which in turn helps the associated As2 O3 to perforate through the cell membranes.
Thus, the Arsenicum album. entered into the cellular environment will create an immunological
stress(57-61). The body will auto activate the defensive mechanism to fight this immunocompro-
mised situation and these quantum biological variations will manifest similar symptom picture
of Arsenicum album. As per homoeopathic prophylaxis we use Arsenicum album. compound
due to its similarity with symptoms manifested in COVID-19 infected patients. This shows that
the person subjected to homoeopathic prophylaxis will develop an immune memory which can
defend against the SARS-CoV-2 virus.
Homoeopathic Management of COVID-19 Pandemic.
Since SARS-CoV-2 is a novel corona virus its epidemiology is not yet completely un-
derstood and viral sensitivity to various drugs are under trials. The present study as a
Page | 74
preliminary medicine trial has found Arsenicun album 30C upregulated the T lymphocytes such
CD4+, CD8+ and CD4:CD8 ratio. The Arsenicum album in its crude form Arsenic Trioxide
which is a poisonous substance, when converted to 30C potency, is a highly potent medicinal
substance capable of curing several diseases. Being an ultra-diluted form, no adverse reactions
of Arsenicun album 30C has been reported at any time in the medical history.
The prevention of communicable diseases is based on the status of the adaptive immun-
ity of a population. If an individual is having proper immunity against a particular disease,
he/she will be left unaffected while the others are affected. The infection is based on the sus-
ceptibility of an individual. All individuals in a population not gets infection, and all infected
individuals are becoming critically ill. Only the susceptible individuals are getting infection
and becoming critically ill. The susceptibility is negatively correlated to immune status of an
individual. When the immune status is high, the susceptibility to getting infection is low.
The management of COVID-19 pandemic, Arsenicum album 30C as a GE in particular
and other individualized and complimentary medicines in general are upregulating and main-
taining the immune status of the individuals. The efficacy of Arsenicum alb 30C for upregulat-
ing the immune markers has been scientifically tested in the study. So, it can be used as a
prophylactic medicine against COVID-19 pandemic and also as curative aspect along with
other complimentary and follow-up medicines. In the present scenario, inclusion of homoeo-
pathic medicine in the main stream COVID-19 management will be more fruitful for prevent-
ing further spread and for effective management of the cases.
Page | 75
CHAPTER FIVE
SUMMARY & CONCLUSION
Page | 76
The study was conducted to find out the efficacy of homoeopathic medicines for up-
regulating the immune status of the individuals residing at COVID-19 related hot spot areas.
The COVID-19 is a rapidly spreading pandemic with high mortality among risk persons. Ho-
moeopathic medicines are generally used for preventing epidemic diseases in the state. The
homoeopathic medicine Arsenicum album 30C was declared by the Central Ayush Ministry
for preventing COVID-19 pandemic. It was reported that, the medicine can be given for in-
creasing the immune status of the individuals. The present study was conducted to find out
whether Arsenicum album 30C increases the immunological markers.
The study was conducted at Pathanamthitta district of Kerala state from March to May,
2020. The Ranni Taluk of Pathanathitta district was reported with COVID-19 after Thrissur
district. The Ranni taluk was declared as hot spot later and lock down was ordered. Considering
as a biological disaster, COVID-19 pandemic exerts psychological stress among the residents
of Pathanamthitta. Keeping this in mind, the psychological stress develops low immunity
among the people of Pathanamthitta. Initially the aim of the study was to find out two facts:
whether any stress was developed due to COVID-19 among the people, and whether any de-
crease in immune status was created with them. If so, the next step was how Arsenicum album
30C respond to the lowered immune status.
The entire study was carried through two phases; an exploratory study (Phase-1) and
an experimental study (Phase-2). There were two objectives in the exploratory study; to find
out the subjective distress and to find out the immune profile of the residents of COVID-19
related hot spot areas. There were 61 participants identified as having subjective distress from
1151 participants interviewed. The major objective of the experimental study was to find out
the efficacy of Arsenicum album 30C for upregulating the immunological markers. The par-
ticipants of this phase of the study was recruited from the 61 individuals identified as having
subjective distress. Thus 16 participants identified as having low immune profile such as CD4,
Page | 77
CD3, CD8, CD4:CD8 ratio and absolute lymphocyte count. The Arsenicum album 30C was
given to the participants and post-test was taken after 5 days. The post-test revealed that, there
were significant pre-post difference reported among all the immunological markers.
Major Findings
1. There are 61 (5.2%) participants are diagnosed with subjective distress among 1151
interviewed.
2. There are 19 (31.1%) participants are having probable diagnosis of PTSD, 12
(19.7%) participants are having PTSD of clinical concern and 30 (49.2%) partici-
pants having PTSD which is capable of suppression of their immune function.
3. The greater number of women participants (40.29%) affected with subjective dis-
tress due to COVID-19 pandemic.
4. The greater number of participants affected with subjective distress belong to the
middle-aged participants.
5. The mean IES-R score of the experimental group is 39.21 which is high enough to
suppress their immune function.
6. Arsenicum album 30C is effective for upregulating absolute CD4 count among par-
ticipants residing in COVID-19 related hot-spot areas.
9. Arsenicum album 30C is effective for upregulating absolute lymphocyte count
among participants residing in COVID-19 related hot-spot areas.
10. Arsenicum album 30C is effective for upregulating CD4:CD8 ratio among partici-
pants residing in COVID-19 related hot-spot areas.
Page | 78
11. Arsenicum album 30C is effective for upregulating absolute CD4 count among fe-
male participants residing in COVID-19 related hot-spot areas.
among female participants residing in COVID-19 related hot-spot areas.
15. Arsenicum album 30C is effective for upregulating CD4: CD8 ratio among female
participants residing in COVID-19 related hot-spot areas.
16. Arsenicum album 30C is effective for upregulating absolute CD4 count among
among male participants residing in COVID-19 related hot-spot areas.
Page | 79
Implications
The COVID-19 was declared as a pandemic illness which is considered as a
biological disaster. The disasters cause physical, psychological, social and eco-
nomic impacts upon the individuals who encounter it as victims or witnesses. It
causes subjective distress which can alter the immune functioning of an individual.
Low immunity resulting from subjective distress PTSD related to COVID-19 make
the individuals more susceptible to catch the infection more easily. So, interventions
that helps to maintain the immune status of the individuals will be beneficial to
prevent further spreading of the disease.
The study concluded that, the homoeopathic medicine Arsenicum album 30 C
is found effective for upregulating the immune markers and there by maintaining
the immunity of individuals with COVID-19 related subjective distress. The Arse-
nicum album 30C is an ultra-high diluted preparation and hence adverse effects not
observed.
Limitations
1. The prevalence of the COVID-19 related subjective distress was not studied due
to lock down restrictions.
2. The experimental phase was conducted using one group before/after design.
3. The immunological assessment took much time as about one week.
Recommendations
1. The oral administration of homoeopathic medicine, ARSENICUM ALBUM
30 C should be advised as a preventive medicine and as an immune booster in
the containment zones on war foot basis in Kerala state.
Page | 80
30 C should be advised as a preventive medicine and as an immune booster
among the population affected with super spread in Kerala state.
30 C should be advised as a preventive medicine and as an immune booster
among the population suspecting community spread in Kerala state.
4. The oral administration of homoeopathic medicine, ARSENICUM ALBUM 30
C should be advised as a preventive medicine and as an immune booster among
the general population of Kerala state.
5. The oral administration of homoeopathic medicine, ARSENICUM ALBUM 30
C should be prescribed to all individuals under quarantine and isolation.
6. The homoeopathic doctors should be allowed to treat COVID-19 patients at
Covid-19 First Line Treatment Centres (CFLTC) with homoeopathic medi-
cines.
7. A multi-system approach (Modern Medicine and Homoeopathy) should be de-
veloped for managing COVID-19 pandemic in the state. Many other states in
the country is already working on it.
8. The homoeopathic doctors should be given proper training for COVID-19 man-
agement and are allowed to work in all the primary, secondary and tertiary lev-
els of disease prevention.
Suggestions for Further Research

1. The study should be replicated using RCT with larger sample size.
2. The study should be replicated with cytokines as dependent variables.
3. Fundamental researches should be carried out on the mechanism of action of
Arsenicum album 30C as an immune booster.
Page | 81
CONCLUSION
The major objective of the study was to find out the efficacy of Arsenicum album 30C
for upregulating the immunological markers among residents of COVID-19 related hot spots
in Pathanamthiatta district of Kerala state. The study found out that, the potentized homoeo-
pathic medicine, Arsenicum album 30C is effective for upregulating the immunological mark-
ers such as absolute CD4 count, absolute CD8 count, absolute CD3 count, absolute lymphocyte
count and CD4:CD8 ratio among the residents of COVID-19 related hot spots. It also found
that, COVID-19 pandemic has created different levels of subjective distress as a result of post-
traumatic stress disorder (PTSD) at residents of hot spot areas in Kerala. The study recom-
mends that, the homoeopathic medicine, Arsenicum album 30C can be used as a preventive
and as an immune booster against COVID-19 prophylaxis in the state. It can be also employed
as a medicine in the COVID-19 First Line Treatment Centres (CFLTC) in the state.
FUNDING
This work has been funded by School of Artistic Homoeopathy for Youngsters and Adults –
SAHYA, a learning platform for qualified homoeopaths focusing on clinical practice and clin-
ical research and along with Dr. Paul Muttaththukunnel. Dr Paul is serving SAHYA as a patron
since January 2019. He is a practicing Homoeopath in Switzerland who is generous in all re-
search activities pertaining to Homoeopathy all over the world.
Conflicts of interests
The authors decaled that they have no conflicts of interests.
Page | 82
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Page | 91
APPENDICES
Page | 92
PERSONAL DTA SCHEDULE
Enroll No………………………… Appendix. 1
Enrol No Date
Date of Birth
Name
Age Sex
Address Mobile
Taluk Rural/ Urban
APL/BPL RESIDENT/NRK
Occupation
Habits Smoking/Drinking/Chewing/Substance
Abuse
Marital Status Single/Married / Divorced/Married-Single
Educational Status Illiterate/SSLC/PDC/Degree/PG/PhD
Blood Group A+/B+/AB+/O+/A-/B-/AB-/O-
Vaccinations BCG/MR/MMR/TT/POLIO
NCD
SINGLE QUESTION SREENING (SQS)

COVID-19 അസുഖം റിപ്പോർട്ട് ചെയ്തതിനു പ്േഷം അചത അലല
നിങ്ങൾ സമ്മർദ്ദത്തിലോപ് ോ?
Page | 93
INFORMED CONSENT
Appendix-2
സമ്മത പത്തം
(INFORMED CONSENT)
ച ോപ്റോ വൈറസ് പ് ോഗത്തിന്ചറ (COVID-19)

പ്രതിപ് ോധപ്രൈർത്തനങ്ങളുമോയി ബന്ധചപട്ട്, സംസ്ഥോന പ് ോമിപ്യോപതി
ൈ ുപ് രത്തനംതിട്ട (ജിലലോ), നോഷ ൽ പ് ോമിപ്യോപതി റിസർച്
ഇൻസ്റ്റിറ്റൂട്ട് ഇൻ ചമന്റൽ ച ൽത്ത്, (പ് ോട്ടയം), പ് ോമിപ്യോപതി
ചമഡിക്കൽ എഡയൂപ്ക്കഷൻ, പ് ള ആയുഷ് ൈ ുപ് , റിസർച് ഇൻ
പ് ോമിപ്യോപതി, പ് ളം എന്നീ സംഘടന ളുചട സ ോയപ്ത്തോചട
പ്രതിപ് ോധ പ്േഷി ൂട്ടുന്നതിന് രത്തനംതിട്ട ജിലലയിചല ജനങ്ങൾക്ക്
പ് ോമിപ്യോപതി മ ുന്നു ൾ നൽ ുന്നതിന്ചറ ഭോഗമോയി നടത്തുന്ന
സർപ്ൈയിലും, തുടർ രഠനങ്ങളിലും രചെടുക്കുന്നതിന് സമ്മതമോച ന്ന്
അറിയിക്കുന്നു. ഈ രഠനചത്തപറ്റി ൈയക്തമോയി ഞോൻ പ്െോദിച്ചു
മനസിലോക്കിയിട്ടുണ്ട്.
പ്രര് ....................................................................................................................................
ൈയസ്സ് ......................................... .................................രു /സ്പ്തീ /പ്ടോൻസ്ചജണ്ടർ
ഒപു ................................................................... ..
സ്ഥലം ...................................................................
തീയ്യതി...........................................................
ചമോവബൽ നമ്പർ.......................................................................
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IMPACT OF EVENTS SCALE
Enroll No…………….. Appendix-3

Imapct of Events Scale-R (Malayalam)
നിർദേശങ്ങൾ
ജീവിതത്തിൽ ചിലദപോഴ ോഴെ ഉണ്ടോകുന്ന സമ്മർേങ്ങളുഴെ ഭോഗമോയി
ആളുകളിൽ അനുഭവഴപെുന്ന വിഷമതകളോണ് തോഴ ഴകോെുത്തിരിെുന്നത്. ഇതിഴല
ഓദരോ ത്പസ്തോവനയും വോയിച്ചു, ക ിഞ്ഞ ഏഴ് േിവസങ്ങളിൽ നിങ്ങൾ
…………………തീയതിയിൽ റിദപോർട്ട് ഴചയ്ത …………………………………………………………..ബന്ധഴപട്ട്
എത്തമോത്തം വിഷമതകൾ അനുഭവിച്ചുഴവന്നു ദരഖഴപെുത്തുക.
ദപര്…………………………………………………………………………….. വയസ്……………സ്ത്തീ/ പു/ ത്െോൻസ്

ജൻഡർ
ഴമോബബൽ നമ്പർ…………………………………………………………………………………………………….
നമ്പർ പ്രസ്തോൈന ൾ തീച ൈളച സോമോനയം ുറച്ച ൈളച

ഇലല ുറച്ചു (2) അധി ം അധി ം
(0) (1) (3) (4)
1 പ്ന ിട്ട ദു ിതചത്ത ുറിച്ചുള്ള
ചെറിയ ഓർമ്മ ൾ പ്രോലും
ൈിഷമിപിക്കോറുണ്ട് 0 1 2 3 4
Any reminder brought back feelings
about it
2 എനിക്ക് ഉറങ്ങുൈോൻ
ബുദ്ധിമുട്ടു
അനുഭൈചപടോറുണ്ട് 0 1 2 3 4
I had trouble staying asleep
3 െില ോ യങ്ങൾ
ദു ിതചത്തക്കുറിച്ചു എചന്ന
ഓർമ്മിപിച്ചു 0 1 2 3 4
ച ോപ്ണ്ടയി ുന്നു
Other things kept making me think
about it
4 എനിക്ക് അസവസ്ഥതയും
പ്ദഷയൈും പ്തോന്നി
I felt irritable and angry 0 1 2 3 4
5 ആ ദു ിതങ്ങചള ുറിച്ച്
ആപ്ലോെിക്കുപ്മ്പോപ് ോ,
ഓർമ്മിക്കുപ്മ്പോപ് ോ മനസ്സ് 0 1 2 3 4
അസവസ്ഥമോ ോതി ിക്കുൈോൻ
സവയം പ്േദ്ധിച്ചി ുന്നു
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I avoided letting myself get upset
when thought about it or was re-
minded of it.
6 പ്ന ിട്ട ദു ിതങ്ങചള ുറിച്ച്
ൈിെോ ിച്ചിചലലെിലും അത്
മനസിപ്ലക്ക് ൈന്നു 0 1 2 3 4
I thought about it when I didn’t mean
to
7 ദു ിതങ്ങൾ
സംഭൈിച്ചിട്ടിചലലന്നും, അത്
യോഥോർഥയമചലലന്നും പ്തോന്നി 0 1 2 3 4
I felt as if it hadn’t happened or
wasn’t real
8 ദു ിതങ്ങചളക്കുറിച്ചുള്ള
ഓർമ്മ ളിൽ നിന്നും ഞോൻ
അ ലം രോലിച്ചു 0 1 2 3 4
I stayed away from reminders of it
9 ദു ന്തചത്ത ുറിച്ചുള്ള
െിപ്തങ്ങൾ മനസിപ്ലക്ക്
ടന്നു ൈന്നുച ോപ്ണ്ടയി ുന്നു 0 1 2 3 4
Pictures about it peeped into my
mind
10 എനിക്ക് ചൈപ്രോളൈും
ചഞട്ടലും അനുഭൈചപട്ടു
I was jumpy and easily startled 0 1 2 3 4
11 ഞോൻ ദു ിതങ്ങചളപറ്റി
െിന്തിക്കോതി ിക്കോൻ
പ്േമിച്ചു 0 1 2 3 4
I tried not to think about it
12 ഇപ്പോ ും
ദു ിതങ്ങചളക്കുറിച്ചു
ുചറപ്യചറ ൈിഷമത ൾ 0 1 2 3 4
എന്നിലുചണ്ടന്നു
അറിയോമോയി ുന്നിട്ടും,
ഞോൻ ആ പ്രശ്നങ്ങചള
പ്േദ്ധിക്കോറിലല
I was aware that, I still had a lot of
feelings about it, but I didn’t deal
with them.
13 ദു ിതങ്ങചളക്കുറിച്ചുള്ള
എന്ചറ ആൈലോതി ൾ ഒ ു
ത ം മ ൈിപോയി 0 1 2 3 4
My feelings about it were kind of
numb
Page | 96
14 ഞോൻ ിഞ്ഞുപ്രോയ
ദു ിതങ്ങളുചട ോലത്തു
ജീൈിക്കുന്നതു പ്രോചലയും ആ 0 1 2 3 4
പ്രശ്നങ്ങൾ
അനുഭൈിക്കുന്നത്
പ്രോചലയും പ്തോന്നോറുണ്ട്
I found myself acting or feeling like I
was back at that time
15 എനിക്ക് ഉറക്കം ിട്ടുന്നതിന്
ബുദ്ധിമുട്ട് ഉണ്ടോയി ുന്നു
I had trouble falling asleep 0 1 2 3 4
16 എനിക്ക് ദു ന്തചത്ത രറ്റി

േക്തമോയ വൈ ോ ി
പ്രശ്നങ്ങളുണ്ടോയി ുന്നു 0 1 2 3 4
I had waves of strong feelings about it
ഓർമ്മ ചള എന്നിൽ നിന്നും
തുടച്ചു നീക്കോൻ പ്േമിച്ചി ുന്നു 0 1 2 3 4
I tried to remove it from my memory
18 എനിക്ക് ഏ ോപ്ഗതപ്യോചട
ഇ ിക്കുൈോൻ പ്രയോസം
പ്തോന്നിയി ുന്നു 0 1 2 3 4
I had trouble concentrating
ഓർമ ൾ അമിതമോയ
ൈിയർപ്, േവോസം മുട്ടൽ, 0 1 2 3 4
ഓക്കോനം, ൃദയമിടിപ്
എന്നീ അസവസ്ഥത ൾ
ഉണ്ടോക്കിയി ുന്നു
Reminders of it caused me to have
physical reactions, such as sweating,
trouble breathing, nausea, or a pound-
ing heart.
20 ഞോൻ ദു ന്തചത്തരറ്റി
സവപ്നം ോ ോറുണ്ട്
I had dreams about it 0 1 2 3 4
21 ഞോൻ ോ യങ്ങചള സപ്േദ്ധൈും

സു ക്ഷിതമോയും
നി ീക്ഷിക്കുന്നുചണ്ടന്നു 0 1 2 3 4
എനിക്ക് പ്തോന്നോറുണ്ട്
I felt watchful and on-guard.
Page | 97
22 ദു ന്തചത്ത രറ്റി
സംസോ ിക്കോതി ിക്കുൈോൻ
ഞോൻ പ്േമിച്ചി ുന്നു 0 1 2 3 4
I tried not to talk about it
Page | 98
HOMOEOPATHIC IMMUNE BOOSTER
INTERVENTION SCHEDULE
EX CN
(Appendix 4)
Enroll No: Date
Name
Age Sex
Address
Mobile
PRE-TEST
Date Time
Blood Pressure Pulse Rate
Height in cms Weight in kgs
BMI IES-R Score
CD4 Count CD8 Count
TC WBC DC WBC
Name of Medicine
Potency
Dosage
Name of Manufacturer
Date of Manufacture
Expiry Date
Batch No
Page | 99
Date Day Dosage Remarks
Morning Noon Night
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
Page | 100
POST-TEST
Date Time
Blood Pressure Pulse Rate
Height in cms Weight in kgs
BMI IES-R Score
CD4 Count CD8 Count
TC WBC DC WBC
Name of Medical Officer Signature with Date
Name of Investigator Signature with Date
Page | 101
ABOUT THE AUTHORS
Thomas M.V.
*Principal Investigator & Corresponding Author
Graduated in homoeopathic medicine from Government Homoeopathic Medical Col-

lege, Kozhikode in the year 1998. Post-Graduation in Clinical Psychology from School of Be-
havioural Sciences, Kannur University in 2012. Worked as research officer for a research pro-
ject carried out by Kerala Police. Published and presented research papers in various seminars
and journals. Conducted a study titled “Development of Homoeopathic Genus Epidemicus for
Secondary Level Prevention of Dengue Virus at Kannur, Kerala” in the year 2018 at Kannur
district Kerala. Conducted a community-based intervention project titled “as “Post- Disaster
Crisis Management through Homoepathy (PDCMH) at Pozhuthana, Grama Panchayath,
Wayanad district Kerala in July, 2018. Submitted PhD Thesis on management of dyslexia
among children at School of Behavioural Sciences, Kannur University, Kerala in 2020. In the
present study, developed research proposal including design, sampling, analysis and report
writing.
Currently working as homoeopathic physician and consultant psychologist at CRAY-

ONS Centre for Learning, Vadakara, Kozhikode. Also volunteering with research activities of
Research In Homoeopathy, Kerala.
Address for Correspondence

NOTRE REVE,
NUT STREET P.O, VADAKARA, KOZHIKODE, (DIST) KERALA, INDIA
Pin 673 104
e-mail: rageethomas@yahoo.com
mobile: +919447540351
Page | 102
Bijukumar D
Currently working in Govt of Kerala AYUSH department and presently holding the post of
District Medical Officer (Homoeopathy) Pathanamthitta District. He entered in Homoeopathy
Department Govt of Kerala 2004 as a Chief Medical Officer. In 2014, promoted as District
Medical Officer. He initiated many innovative action plans in the field of Homoeopathy. He
contributed a lot for the upliftment of the project "JANANI" Infertility treatment project which
is one of the prestigious activities of Homoeopathy department. He is presently holding the
charge of State Nodal officer of JANANI project. JANANI centre at Kannur is now declared
as India's first centre for excellence in the field of Homoeopathy. During his tenure as DMO at
Kannur, Government of Kerala started first IP Bedded hospital in a tribal area, At Aralam
farm, Kannur and associated with Dengue study at Kannur. During the COVID-19 pandemic
Pathanamthitta district done a commendable and role model work in prevention activity. Ho-
moeopathy Immunity Booster Medicine was distributed to 97 % of population in
Pathanamthitta district.
Dr.Bijukumar is also a well reputed cultural personality in Indian film industry. He received
India's national film award three times and won more than 30 International film awards.
Page | 103
Oriparambil Sivaraman Nirmal Ghosh
Head of Research in Homoeopathy and working as Scientist- D in Advanced Research Labor-

atory, Homoeopathic Medical Education, Department of AYUSH, Government of Kerala. Dr.
Ghosh received his Bachelors in Physics in 2006 from the University of Calicut, India and
obtained his Masters in Physics in 2008 from Annamalai University, India. He received his
M.Tech. in Nanoscience and Technology in 2012 from Pondicherry University. During 2012 to
2016, he did his Ph.D. in Nanoscience and Technology at Centre for Nanoscience and Tech-
nology in Pondicherry University under the supervision of Dr.Annamraju Kasi Viswanath and
continued there for his short post doctoral research work till 2017. He played a critical role in
establishing Nanophotonics and Nanoelectronics Research Laboratory at Centre for Nanosci-
ence and Technology. During his doctoral and post doctoral period he worked in the major
areas in Nanotechnology including, development of multifunctional nanohybrid materials for
nanomedicine and multiple electron transfer catalysis. His major expertise is in design, synthe-
sis and characterization of nanomaterials, surface interface engineering, bandgap engineering
and fabrication of dimensionally modulated nanohybrids for various applications like nano-
medicine, environmental remediation, nanophotonics, nanoelectronics, nanomagnetism and
smart nanomaterials for energy conversion and storage.
He is involved in various projects focusing on characterization, development and scientific
validation of AYUSH systems of medicines in collaboration with national and international
research institutes and organizations. His current interest is in understanding the nanodimen-
sional properties of materialistic constituents present in Ayurveda, Siddha, Unani and Homoe-
opathy Medicines by exploring its structure-property relationships, physicochemical properties
and its association with quantum biological interactions in biological systems.
Page | 104
K.C.Muraleedharan
Graduated in homoeopathy BHMS from Mahatma Gandhi University, Kerala, MD(Homoeo)

(MUHS, Maharashtra). Joined in service of Central Council for Research in Homoeopathy on
12.11.1995 as Research Assistant (H) at CRIH, Kottayam, Kerala. Worked under different pro-
jects like Behavioral disorders, Mental retardation, psychosomatic disorders and HIV/AIDS
etc. Worked in Multicentre Trial of Homoeopathic medicines in HIV Infection and Investiga-
tor of the Fundamental Research Study at RRI, Navi Mumbai in collaboration with BARC.
Introduction to HIV/AIDS Research/ Introduction to Training Methodology CARAT (Cell for
AIDS Research Action & Training), Dept. of Medical and Psychiatric social work, Tata Insti-
tute of Social Sciences. Mumbai 23rd to 30th December 2002. One-month training programme
“Einstein AITRP-India training for AIDS Researchers” at Nair Hospital, Mumbai organized
by Dept. of Microbiology in collaboration with Albert Einstein College of Medicine, New
York, USA. 7th January 2008 to 1st February 2008. Completed 3 days Middle Tier training
Programme for AYUSH Officers at IIM (Ahmadabad) from 22nd to 24 April 2011. Undergone
training for Anu Rheography and Medical analyzer at Bhabha Atomic Research Centre
(BARC)
Page | 105
Biju S.G
S.G.Biju is an ardent, seasoned and passionate Homoeopath. He is practicing this genre of

medical science since 1992. He has done DHMS from HMC, Kottayam, and Graded BHMS
from GHMC, Kozhikode and MD (Hom) from Mumbai University. He is an Assistant Profes-
sor in department of repertory in WMH Medical College, Kanyakumari Tamil Nadu. His main
area of interest and speciality is Hepatitis-B. He cured almost 5000 patients who were diag-
nosed Hepatitis-B positive shows his result oriented approach Autoimmune disease, & Meta-
bolic disorders, Developmental abnormalities in children, foetal anomalies ADHD are his other
areas of interest. His accolades include Dr.Samuel Hahnemann National Award 2003, N.K
Jayaram State Award 2007, & Best guest lecturer award in the year 2009. He is the Best Private
Practitioner Award winner of Government of Kerala for the year 2017.
He presented papers in various national and International Seminars. 'Homeopathic treatment

protocol for Hepatitis-B ' in Dubai, Homoeopathic management of Cancer at Kula Lumpur
Malaysia/Singapore and Sri Lanka were appreciated by one and all. He is a Trainer, Mentor
and beyond all a Philanthropist. He adopted 165 HIV affected children since 2005, Accommo-
dated 103 junior doctors for training in his hospital where many of them are practicing inde-
pendently as successful Homoeopaths. He always support and foster the young buds in Ho-
moeopathy to take the best out of them. He has published various articles in leading interna-
tional and national Homoeopathic Journals like Homoeopathic heritage. His Maiden book “The
Symphony of Homoeopathy” was one of the best sellers from B Jain Publishers India. Within
32 days first edition is sold out. Second & 3rd editions of Symphony of Homoeopathy are also
a best seller till date. This book is an avid contribution to Homoeopathy through his 25 years
of experience, knowledge and wisdom.
Page | 106
Page | 107
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Efficacy of Arsenicum Alb 30c For Upregulating Immunological Markers Among Residents of Covid 19 Related Hot Spot Areas in Pathanamthitta Kerala

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EFFICACY OF ARSENICUM ALB 30C FOR UPREGULATING IMMUNOLOGICAL

Preprint · July 2020

Thomas Marangattil Varghese O. Sivaraman Nirmal Ghosh

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RESEARCH PROTOCOL FOR GENUS EPIDEMICUS STUDY. View project

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EFFICACY OF ARSENICUM ALB 30C FOR UPREGULATING

IMMUNOLOGICAL MARKERS AMONG RESIDENTS OF

COVID-19 RELATED HOT SPOT AREAS IN

NIRMAL GHOSH O.S

Dr. Vijayambika M.N

Dr. Paul Muttathukunnel

Epidemics and Pandemics 3

Stress and Immunity 5

Objectives of the Study 6

Cells of Cellular Immune System 12

CD3, CD4 and CD8 Cells 14

Psychological Stress and Immunity 16

Homeopathy and Immunity 17

Procedure for Data Collection 24

Procedure for Data Collection 30

Results of Exploratory Phase-1 34

Analysis of IES-Score and Sex 38

Analysis of IES-Score and Age 39

Results of Experimental Study Phase-2 41

Pre-post Assessment of Absolute CD4 Count 44

Pre-post Assessment of Absolute CD8 Count: 46

Pre-post Assessment of Absolute CD8 Count 51

Pre-post Assessment of Absolute CD4 Count:

Pre-post Assessment of Absolute CD4 Count: 52

Pre-post Assessment of Absolute CD3 Count 57

Pre-post Assessment of Absolute CD3 Count: 58

Pre-post Assessment of Absolute CD3 Count: 59

Pre-post Assessment of Absolute Lymphocyte 62

Pre-post Assessment of Absolute Lymphocyte 63

Pre-post Assessment of Absolute Lymphocyte 64

Pre-post Assessment of CD4:CD8 Ratio 67

Pre-post Assessment of CD4:CD8 Ratio: 68

Pre-post Assessment of CD4:CD8 Ratio: Males 69

Hypothetical Proposition on Modus Operandi of

Arsenicum Album 30C 74

Homoeopathic Management of COVID-19 75

5.SUMMARY AND CONCLUSION 76

Suggestions for Further Research 81

Appendix-1 Personal Data Schedule 93

Appendix-2 Informed Consent 94

Appendix-3 IES-R (Malayalam) 95

Appendix-4 HIB Schedule 99

ABOUT AUTHORS 102

seemed to be skewed by the pharma mafias as if money is the matter.

more than 30 deaths in Kerala.

Homoeopathy is an alternative way to restore health in stressed situations like this.

epidemicus can be developed only after reporting a disease in a population.

It was hypothesised that, homoeopathic medicines maintain immunity in stressed

As a scientific research, especially in homoeopathy we have deployed our highest-level

of commitment. Discussed with the experts in the field of homeopathy, psychology,

milestone laid for the development of experimental research in homoeopathy.

17th July, 2020

Need to say thanks to many...

We would like to extend our immense gratitude to

Dr. Manikandan, Professor, Department of Psychology, University of Calicut.