SYNOPSIS OF THE DISSERTATION SUBMITTED FOR THE DEGREE OF M.S.

(AYU)
IN
SHALAKYA TANTRA
YEAR 2022-2025
TO
M.U.H.S. NASHIK
TITLE

“A Randomized Controlled Clinical Study Of Efficacy Of Jambvadi Taila

Karnapoorna In Karna Srava With Special Reference To Chronic
Suppurative Otitis Media”

Title Of Synopsis For M.S. (Ayu)

In
Dept. Of
Shalakya Tantra

P.G. Scholar
Vd. Ratandeep Patel
Admission Date:- 14/02/2022
Reg. No. 58239

H.O.D GUIDE

Dr. Khan Nisar Ali Dr. Khan Nisar Ali

M.S. (Shalakya Tantra) M.S. (Shalakya Tantra)

DEAN
Dr. Y.R. PATIL
M.D.,Ph.D (Swasthvrutta)

Research Place
Government Ayurvedic College and Hospital,Nanded
2022-2025
MAHARASTRA UNIVERSITY OF HEALTH SCIENCE,NASHIK
 Check list
(For submission of proposal to the University)
Academic
1. 2022-2025
Year
2. Subject SHALAKYA TANTRA
3. Name of the
Dr. Ratandeep Patel
student
Mob no- 9425483546
Email-ratandeeppatel786@gmail.com

4. Eligibility Yes/No Yes

5. Name of
Dr. Khan Nisar Ali
Guide and
Associate Professor
Designation
Dept. of Shalakyatantra
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of Guide
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MUHS/D-3/PG/18/4/2022
mention
Dt. 23/04/2022
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7. Guide having Yes
approved 05 32 years
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teaching.
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topic by P.G.
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Signature

Dean
Seal of college Govt. Ayurved College, Nanded
 Appendix 'A'
Name of college Government Ayurved College, Nanded
Department Shalakyatantra
Name of guide Dr. Khan Nisar Ali
Through Proper Channel only
TO,
The Registrar,
M.U.H.S. Nashik- 422004
Sub: Submission of Title & Synopsis Dissertation
Respected Sir/Madam,

I Dr. Ratandeep Patel registered for M.S. (Ayurveda Dhanvantari),

Shalakyatantra in the 2022-2025 batch under the guidance of Dr. Khan Nisar Ali,
M.D. (Shalakyatantra, ), Associate Professor, Dept. of Shalakyatantra, G.A.C. & H,
Nanded. I am due to appear for course M.S.(Ayurveda Dhanvantari) Shalakyatantra,
preliminary exam in SEP-2021.
I am submitting herewith Title & Synopsis of Dissertation as mentioned below &
as suggested by my aforesaid Guide.
Kindly accept and register my title of synopsis.
" A Randomized Controlled Clinical Study of Efficacy of Jambvadi Taila
Karnapoorna in Karna Srava with special reference to chronic
Suppurative otitis Media."
P. G. Scholar

Dr. Ratandeep Patel

The guide is recognized as P.G. Teacher by the university vide letter no.
MUHS/D3/PG/18/4/2022 Dt.23/04/2022

HOD GUIDE
Dr. Khan Nisar Ali Dr. Khan Nisar Ali
M.S.(Shalakya Tantra) M.S.(Shalakya Tantra)
Dean
Dr. Y. R. Patil
M.D., Ph.D. (Swasthvrutta)
 Appendix 'B'
REPORT OF ETHICS COMMITTEE
Department Shalakyatantra
Candidate admitted year 2022-2025

Course and Subject M.S.(Ayu.), Shalakyatantra

College Name & Address Government Ayurved College, Vazirabad, Nanded-
431601
Reference No. Date:

To,

Dr. Ratandeep Patel.

Shalakyatantra Department,
Government Ayurved College,
Vazirabad, Nanded- 431601
Sub:- " A Randomized Controlled Clinical Study of Efficacy of Jambvadi Taila
Karnapoorna in Karna Srava with special reference to chronic
Suppurative otitis Media."
Ref:
Dear Student,
The above mentioned research proposal of Title &Synopsis of Dissertation was
discussed in the Ethics Committee meeting held on at our college.
It is declared that-
1. The said title of synopsis is not repeated.
2. You are registered under Dr. Khan Nisar Ali who is university Recognized P.G.
teacher Vide University letter no. MUHS/D3/PG/18/4/2022 Dt.23/04/2022 For
guidance & supervision during the course of studies
3. Ethics committee has unanimously approved your title & synopsis of dissertation.
4. The title recommended for study by the student from date

Chairperson,
Institutional Ethics Committee
Government Ayurved College, Nanded
 CERTIFICATE

This is to certify that the present synopsis on the topic " A Randomized Controlled
Clinical Study of Efficacy of Jambvadi Taila Karnapoorna in Karna Srava with
special reference to chronic Suppurative otitis Media." By Vd. Ratandeep Patel
has been prepared under my guidance.

I also declare that the work on the mentioned topic will be carried under my
direct supervision.

HOD GUIDE

Dr. Khan Nisar Ali Dr. Khan Nisar Ali

M.S.(Shalakya Tantra) M.S.(Shalakya Tantra)

Date:-
Place:- Government Ayurvedic College and Hospital, Nanded
1. TITLE:

“A Randomized Controlled Clinical Study of Efficacy of Jambvadi Taila

Karnapoorna in Karna Srava with special reference to chronic Suppurative otitis
Media”
2. INTRODUCTION:
Chronic suppurative otitis media (CSOM) is, for the purposes of this document,
defined as a chronic inflammation of the middle ear and mastoid cavity, which
presents with recurrent ear discharges or otorrhoea through a tympanic perforation.
The disease usually begins in childhood as a spontaneous tympanic perforation due to
an acute infection of the middle ear, known as acute otitis media (AOM), or as a sequel
of less severe forms of otitis media (e.g. secretory OM). The infection may occur
during the first 6 years of a child’s life, with a peak around 2 years. The point in time
when AOM becomes CSOM is still controversial. Generally, patients with tympanic
perforations which continue to discharge mucoid material for periods of from 6 weeks
to 3 months, despite medical treatment, are recognized as CSOM cases. The WHO
definition requires only 2 weeks of otorrhoea, but otolaryngologists tend to adopt a
longer duration, e.g. more than 3 months of active disease.

‘Karna Sarav’ is a disease mentioned by Acharya Sushruta in the chapter named

Karnaroga Vigyaniya under twenty eight karnarogas. Acharya Charka included
Karna Sarav as a Puti pooya srava under Pitta karna roga. Acharya Vagbhatta has
described as a ‘Karna Sarav’.

Chronic Supportive Otitis Media is an important cause of preventable hearing loss,

particularly in developing world. It is a reason of serious concern, particularly in
Children, because it may have long term effects on early communication,
language development, auditory processing, psychological, cognitive, development,
educational progress and achievement. Risk factor include age ( < 5 years old ), male
sex, ethnicity (White ), low birth weight (< 2.5 kg ), premature birth ( < 37 weeks
gestation ), season of Birth (spring / summer), lack of breast feeding, lower
socioeconomic groups and Poverty. These factors lead to the increased prevalence of
‘Karna Sarav’ which is 6% in India among the children.

Acharya Govindnath Sen ( in Bhaisjya Ratnavali ) has advocated use of Jambvadi

Tail Karnapooran for treatment of Puya Karna Sarav

1
 3. NEED FOR STUDY:
Chronic Suppurative Otitis Media is characterized by recurrent purulent
discharge, hearing loss, perforation of tympanic membrane and oedematous middle
ear mucosa. Recurrences are fairly common in spite of repeated antibiotics, steroids
and surgeries. Causative factor of Tubotympanic type of otitis media lies in nasal
cavity, paranasal sinuses, nasopharynx or pharynx. Therefore present study has been
planned to evaluate the etiology of the disease, course of the disease and management
with the help of some herbal drugs with hope that these will prove to be more
efficacious and least toxic.
So keeping this in mind, based upon the etiopathogenesis of Karna Roga
The drug formulation ‘Jambvadi Taila Karnapooran which is described in classical
text Bhaisjaya Ratnavali for chikitsa of Karna Roga have been selected for present
study. Karnapooran with Jambyadi Taila will be beneficial for eradication of
tympanic cavity’s disease.

A large number of Chronic Suppurative Otitis Media patients with purulent

Discharge, earache, itching come to O.P.D of our institution. These symptoms
are neglected by patients causing many complications. To deal with such morbid
conditions, this topic is selected for study.
JAMBVADI TAIL has kasaya rasa so it has sthambhan and vranropan properties
hence it can be use in Karna Sarav roga

2
4. Research questions
3.1Primary research question:
Is Jambvadi Taila
Karnapoorna is effective in treatment of Karna Srava with special reference to
chronic Suppurative otitis Media?

4.. Hypothesis
Primary Hypothesis
Null Hypothesis (Ho)
Jambyadi Taila Karnapooran (4-6 drops BD) for Pratahkala and Sayamkala for 15 days
have no role in the management of Chronic Suppurative Otitis Media.
Alternate Hypothesis (H1):
Jambyadi Taila Karnapooran (4-6 drops BD) for Pratahkala and Sayamkala for 15 days
is effective in the management of Chronic Suppurative Otitis Media.
4 .2. Other Hypothesis:
Independent Variable- Chronic Suppurative Otitis Media.
Dependent Variable – Otorrhoea
-Earache
-Hearing impairment .

Review of literature
5.1 Recent Work
1) 10 / 9 / 2017 Article in lnternatlonal Journal of Ayurveda Pharmaceutical
Chemistry
- Abha Singh and Aru n Kumar – The role of Karnadhupan in the
management of Chronic Suppurative Otitis Media ( Karnasrava) – A
case study.
2) August 2017 Article in Journal of Ayurveda and Integrated Medical Sciences –
Anamika, Vined Jadhav and M . R. Sajjanshetti! – Ayurvedic approach to the
management of Kamasrava with special reference to Chronic Suppurative Otitis
Media – Critical review.
3) 31/7/2017 Article in World Journal of Pharmaceutical and Medical Research –
Dr. Manish Katare - Priyanguadi Taila in the management of Karnasrava
with special reference to Chronic Suppurative Otitis Media.

3
 4) 5 / 1 / 2015 Article in Journal of Internationa l Archives of Integrated Medicine
A review on Otitis Media (karnapaka ): Ayurvedic aspects and treatment –
Nisha and Lokesh.
5) Bengalore - 2011 - Dr. Shashikala D.K. – Comparitive study on the efficacy of
Vacha Lashunadi Taila Karnapichu and Nimb patraadi dhoopan in the
management of Kama srava.
6) Bengalore – 2008 – Satish Shankar B. – Management of karnasrava with
sthanic guggulu dhoopana and rasnadi guggu!u. A comparative study.
7) Shimala – 2005-Monika – Role of Ayurvedic drugs in management of Karna
srava with special reference to Chronic Suppurative Otitis Media.
8) Jamnagar – 2005 – Javale Anant: - A clinical study on the efficacy of Arka taila
in the management of Karna – strava special reference to otomycosis.
9) Bangalore- 2001- Nagendra Kumar – Evaluat ion of Koma Poomnkriya in the
management of karna strava with special reference to Samudraphena churna
and Kshar taila
10) Trivendrum – 1998 – Kishor K – Management of Karna Sarav with special
reference to a combination .
11) Bengalor e – 1996 – S.P. Suresh - Role of kamapoomn in the management of
karnasrava with special reference to kshara – A clinical study.
12) Hyderabad University - 1990 - Narayan Rao Y.V . - Management of
karna strava with the Kama Prakshalan with Vidang Kwath.
13) Jamnagar-1987 – Patel G.M . - Role of Jati taila and Sarivadivati in Kamastrva.
14) Hyderabad Universit y – 1987 – Manikya Rao-Management of Karna Sarav
with Jatyadi Taila Karnapooran.
15) Jamnagar -1979 – Navadia SP – Kama Strava – Prayogat ma k Adhyayan.
16) GAC, Nanded Vd. Pandit Pooja- 2017-2020- Clinical study of efficacy of
Jambvadi taila Karnapuran and anutaila Nasya in Karna Sarav with special reference to
chronic suppurative otitis media.

References:
1) Dr. Kaviraj Amb ikadat ta Sha st ri – Sushruta Samhita Uttartantra –
Chaukhambha Sanskrit Sansthan.

2) Dr.Bramhanand Tripathl – Charak Samhita Uttaradlw – Chaukhambha Surbha

rati Prakashan.

3) Dr. Ganesh Krlshna Garde-Sarth Va gbhatt a – Utt arst han - Anmol

Prakashan, Pune

4) P. L. Dhingra – Disease of Ear, No se, and Throat and Head and Neck Surgery-
Elesivier.

5) Dr. lndradev Tripathi, Dr.Dayashankar Tripathi – Yogratnakar – Karnaroga

-Chaukhambha Krishnadas Academy, 4 Varanasi.
6) Kaviraj Atridev Gupta – Ashtanghridayam Vidyotini teeka – Chaukhaimbha
Prakashan Varanasi.

7) Yadavji Trikamaji1 Aacharya - Sushruta Samhita Dalhan Teeka - Krishnadas

Academy, Varanasi.

8) Shree Bramhashankar Mishra – Bhavaprakasha – Vidyotinee Teeka –

Chaukhambha Sanskrit Sansthan, Varanasi..

9) Shalakya Tantra ( Nimitantra ) – Dr. Ramesh Dwivedi - Chaukhambha Bharati

Prakashan.

10) Dravyaguna Vidnyan – Aacharya Priyawat Sharma -Chaukhambha Bharati

Academy.

11) Bhaishajya Ratnawali – Dr. Kaviraj Ambikadatta Shastri.

12) Short textbook of E. N.T. – Dr. Bhargava – Usha Publications.

13) Researches in Ayurveda 2005-Vd. M .S. Baghel – Mridu Ayurvedic Pub and
Sales.

14) Shiro - Karna - Nasa - Mukharoga Vidnyan - Dr. Narayan J. Vidhvansa -

Aanand Prakashan Amravati.

15) Website: www.sciencedirect.com lnternational Journal of Paediatric

Otorhinolaryngology, Elsevier Science Ireland limited – Chronic Suppurative
Otitis Media prevalence and practices among rural South Indian Children dated
25th May 1999. Page number 217, Visited on 1/2/2018.

5
Literary Review:
Karna Sarav is a disease mentioned by Acharya Sushruta in Uttartantra in the
chapter ‘Karnagata Roga Vidnyaniyam’ among 28 Karnagata Roga in Adhyay no. 20
Karna Sarav Samprapti:
Pathophysiology of Karna Sarav explained by Aacharya Sushruta, Karnagata kapha get
vitiated and liquefied by teja guna of pitta dosha . This kapha gets started discharging
with or without pain produces Karna Sarav. [ll
According to Aacharya Dalhan, in Karna Sarav, the discharge is purulent ,
thick with recurrent episodes.
According to Aacharya Yogratnakar, any abscess (karnavidr:adhi) in the ear or
pouring water (ambupooran) in the ear leads to Karna Sarav.

Pootikarno Chikitsa:

Shirovirechana, Dhupana, Karnapooran, Pramarjan, Karnadhavan this is a

common treatment of Karna Sarav.

Chronic Suppurative Otitis Media:

It is a very common condition in our country. It may remain a benign condition
or at times may lead to fatal intracranial complications.

Aetiology:
1) Age – It occurs at all ages.

2) Sex-Both the sexes are equally affected.

3) Predisposing Factor-
a) Acute Otitis Media which fails to clear may persist as Chronic Otitis Media, happens
When
• Upper respiratory tract infections.

• Resistance of body is low,

6
 4) Causative organisms Streptococci, pneumococci, staphylococci, Bacillus
fragilis and Bacillus coli.

Symptoms:
1 ) Otorrhoea

2) Hearing impairment

3) Earache

Signs :

1) Tympanic membrane perforation.

2) Tenderness – on the mastoid antrum .

Treatment of Benign perforations

A) Active stage with otorrhoea..
Conservative treatment –

1) Removal of septic foci like adenoids and tonsils and treatment of

sinusitis and deviated nasal septum should be carried out.

2) Aural toilet – Cleaning should be done with a dry clean swab stick or
suction.

3) Antibiotic ear drops – If discharge is there.

Surgical treatment-
1) Polyps and granulations should be removed.

2) Tympanoplasty- Reconstruction of ear drum and ossicular chain.

7
 5. Objectives
6.1 Primary Objectives:

• To find the treatment which is effective, easy to perform and readily available
for Karna Sarav.
6.2 Secondary Objectives:
• To assess efficacy of Jambvadi Tal Karnapooran. It’s local effect along with
effect of pacifying nasopharyngeal doshadushti in Karna Sarav.
• To prevent recurrences of Karna Sarav.

8
 Methodology

A. Study type – Prospective, Open labelled, Randomized, Controlled, Clinical study.

B. Study Duration- 15 days of treatment to each patient with follow up on 7 th, 15th, 30th
day. During two years of post-graduation course
C. Study design – Prospective, Open labelled, Randomized, Controlled, Clinical study

Initial assessement and selection of patients

Informed consent of patients

Randomized Group allocation by

Experimental group Control group

Anutaila Nasya (6-8 drops) Anutaila Nasya (6-8 drops)
1st to 7th day (O.D) 1st to 7th day (O.D)
Jambwadi Taila Karnapooran Chloromphenicol + Polymyxin B
(4-6 drops BD) Sulphate ear drop (3 drops TDS)
st th
1 to 15 day 1st to 15th day

Assessment on 0, 7 & 15th day Assessment on 0, 7 & 15th day

Follow up on 30th day Follow up on 30th day

Collection, classification and presentation of Data

Statistical analysis

Conclusion
9
 Method:

1) Trial group - Selected patient will be examined and observations will

be recorded.
► Poorva Karma : Sthanik abhyango with Tila taila and Nadi sweda will be given.
All the discharge and debris will be removed from the ear by dry mopping with absorbent
cotton buds before Karnapooran.

► Pradhan Karma : Nasya: Anutaila’s 6-8 drops, in each nasa (nostrils) will be
instilled.

► Karnapooran :Jambvadi Taila’s 4-6 drops in karna (auditory meatus) will be

instilled. Ear will be cleaned after 100 matra approximately for 1-2 minute.

► Paschat Karma: Luke warm water Gandusha will be given.

2) Control group - Instillation of Chloromphenicol + Polymyxin B Sullphate ear

drop (3 drops TDS) Anutaila nasya(6-8) drops as described above.

7.2 Study setting (Location):

O.P.D and IPD of Shalakya Tantra Department of our institute.

7.3 Study population:

Patients of Pootikarma coming across O.P.D.of Shalakya Tantra Department of Our

institute, selected as per criteria.

7.4 Sample size:

A. Sample size: Total sample size for the present study will be 30 in each
group.

B. Sample Size calculation

10
 1. Sample size is calculated by the formula and the preva1lence rate of the
disease.
2. International Journal of Paediatric Otorhinolaryngo1logy has published Prevalence
among rural South Indian children of Chronic Suppurative Otitis Media is 6% subjects
in India dated 25th May 1999.

C. Sample size Calculation

Sample size calculation formula- Danniel 1999,

𝑧 2 𝑥𝑝𝑥(1−𝑝)
𝑛=
𝑑2
(1.96)2 ×0.06×(1−0.06)
𝑛= (0.1)2
3.841×0.06×0.94
𝑛=
0.01
𝑛 = 21.65

Where,
n = Sample size,
z = Level of significance (1.96),
p = Prevalence rate (6%),
d = Allowable error (0.1),
Hence sample size 30 will be taken for the study.
7.5. Sampling Technique
Simple, Randomized sampling technique. (Lottery Method)
Selection of patients according to selection criteria and randomly allocating
group by lottery method.

7.6. Methods of Selection of study subjects

A. Inclusion criteria:

• Patients suffering from Karna Sarav that is Tubotympanic type of Chronic

Suppurative Otitis Media without complications.

• Patient of age group of above 7 years are taken under trial, irrespective of sex,
caste, religion, socio- economic and educational status.

• Patients willing for treatment.

11
B. Exclusion criteria:

1. Local

• Acute Otitis Media.

• Attica-antral type of Chronic Suppurative Otitis Media.

• Posterio-superior marginal /attic perforation of tympanic membrane.
• Patients with Cholesteatoma.
• Patients with signs of mastoiditis
• History of middle ear or mastoid surgery
• Patients with congenital deformities.
• Malignancy/ aural polyp.
• Blockage due to stenosis of external auditory canal.

2. systemic
• Chronic alcoholic patients
• Patients with psychosomatic disorder.
• Patients with acute systemic or infectious diseases.
• Patients with cardiac, renal or hepatic impairment .
• Patients not willing for treatment.

C withdrawal criteria
• Occurrence of serious adverse events .

• Occurrence of any other systemic diseases or complications.

• The protocol has been violated or patient becomes uncooperative.

The patient is not willing to continue the trial or to follow the assessment
Schedule.
• Occurrence of any illness which may interrupt the efficacy of drug .

12
13
14
15
7.7 Operational Definitions

► Sthanic Abhyanga- External massage w1th koshna Tila taila over forehead,
face, cheek & neck.

► Sthanic Swedana
Swedana with the help of Nadi sweda ya.ntra on all over the face, cheek, neck &
by Protecting the eyes for 5 minutes

► Karnapooran – Pouring liquid forms of medicine ln Karna (auditory meatus) and

is kept for some time.

► Nasya – It is a therapy in which the various forms medicines can be

Administered through the Nasa (nostrils).

► Kharapaka: In Snehapaka vidhi, if kalka gets Hard after evaporating water, that
Paka is called Kharapaka .

► Pure Tone Audiometry : It is the key hearing test used to identify hearing
Threshold levels of an individual, enabling determination of the degrees type
and con figuration of a hearing loss.

Gradation of subjective parameters:

Grade Earache
1 No earache

2 Occasiona1

3 Intermittent and not incapacitating normal activity.

1. Hearing impairment

16
 2. Hearing impairment
Grade Hearing rmpairment

0 No Hearing rmpairment

1 Mild 20-40db

2 Moderate 40-60db

3 Profound> 60 dB

Gradation of Objective parameter

Nature of ear discharge
Grade Nature of ear discharge
0 No discharge

1 Mucoid discharge
2 Mucopurulent discharge.
3 Purulent discharge

Amount of discharge
Grade Amount of discharge
0 Absent

1 Mild – Present in medial half of external meatus.

2 Mild – Present in medial half of external meatus.

3 Moderate filled external meatus

4 . Severe – Pouring out of external meatus.

17
3 Perforation (central) grading
Grade Central perforation
0 No Perforation
1 Small central.
2 Kidney shape
3 Total perforation.

4 Inflammation
Grade Middle ear
0 Pale, pink, moist middle ear mucosa, no otitis externa.
1 Redness in middle ear mucosa, oedemetous tympanic membrane
without otitis externa
2 Redness in middle ear mucosa, oedemetous tympanic membrane
with otitis externa

18
Investigations
1) C.B.C
2) B.S.L.(R)
3) Urine routine and microscopic.
Local
1) External ear, nasal cavity and pharynx By Bull’s lamp and Head mirror.
2) Oto- Endoscopy
3) Tunning Fork test.
4) Pure tone Audiometry.

7.8 Methods of Measurement

 History Taking
 Local Examination
 Laboratory Findings
 Pure Tone Audiometry

7.9 Study Instruments ( Data collection tools)- Case Record form

1) Torch
2) Bull’s lamp and Head mirror
3) Aural Speculum
4) Otoscopic/ Otoendoscope
5) Tunning Fork
6) Jobson Horne’s Probe

19
7.10 Method of Data Collection relevant to objectives:
Treatment will be given for 15 days and follow up of patients will be taken for
one month and observations will be recorded in tabular form.

Sign and Symptoms 1st day 7th 15th 30th

Nature of Discharge
Earache
Hearing impairment
Perforation
Inflammation
Amount of discharge

7.11 Data Management and collection:

 Collected data will be summarized in the forms of master charts.
 Further classification and presentation of data will be done in the form of Tables
and graphs.
 Finally data will be analysed statistically to draw conclusions.

7.12 Data analysis plan and methods

A. Data analysis plan
Statistical analysis:
(1) 𝝌𝟐 test for qualitative data at the base line.
(2) Wilcoxon test will be applied for qualitative data to access efficacy of
treatment in each group.
(3) Mann Whiteys test will be applied qualitative data to compare both groups.
(4) 𝝌𝟐 test will be applied to compare overall effect of treatment in both groups.
(5) Level of significance will be kept p = 0.05.

20
 B. Overall effect of Therapy(Overall assessment criteria):
After the end of the study, by using subjective and objective parameters
assessment will be done. Significance of improvement will be classified as
following:
i. Cured – Total improvement in all criteria.
ii.Moderate improvement- partial improvement in all or some objectives
and subjective criteria.
iii. No improvement- no improvement in any objective or subjective
criteria.
Efficacy of The Treatment Score Total Assessment
Excellent 0 75-100% Relief in sign and symptoms
Moderate 1-5 50-75% Relief in sign and symptoms
Mild 6-10 25-50% Relief in sign and symptoms
Ineffective 11-17 0-25% Relief in sign and symptoms

21
22
23
Anutaila:

Rasa- Maximum ingredients have Madhura, Katu and Tikta

rasa which are Kaphashamak, pittashamak and
vatashamak i.e. overall tridoshghna.

Vipak - It is Madhura and Katu maximum Dravyas.

Virya - Maximum ingredients possess ushna virya which is

vatashamak.

Doshaghnata - Vatakaphashamak

Guna - Laghu, Ruksha.

B) Control group

Chloromphenicol (0.4%) + Polymyxin B Sulphate-5000 IU/ml ear drop

and Anutaila.

C) Preparation of Drug:

Preparation of research drug Jambvadi Taila will be prepared

according to reference of Yogratnakor. All the drugs will be taken in
equal amount, except Tila taila and Shuddha Vatsanabh will be taken 1/4
th and 1/16 th respectively.

Taila will be prepared by Snehapaka vidhi where the paka will be

Kharapaka. Anutaila will be purchased from local market.

D) Drug Standardization:

Authentication and standardization of drug will be done in drug

testing laboratory of our institute's pharmacy and outside Authorized
laboratory.

7.14. Randomization/Allocation concealment:

 Selected 60 patients will be randomly distributed into two equal

groups each comprising 30 patients.
 Groups will be named as Group A and Group B.

Group A will be Trial Group while Group B will be control Group.

24
25
8. References:

1) शिरोऽशिघातादथवा निमज्जतो जले प्रपाकादथवाऽपप पवद्रधेेः ।

स्त्रवेत्तु पूयं श्रवणोऽनिलावत
ृ ेः स कणणसंस्त्राव इनत प्रकीनतणतेः
Dr. Kaviraj Ambikadatta Shastri - Sushruta Samhita Uttartantra Chaukhambha
Sanskrit Sansthan, Varanasi, Reprint 2017, Page number 117, Verse Sushruta
Uttartantra 20/15.

2) जम्ब्वाददतैल तरुणं समांिं कपपत्थकापाणसफलञ्च साद्रण म ् ।

क्षुत्वा रसं तं मधुिा पवशमश्रं स्त्रावापहं तं प्रवदन्तत तज््ाेः
एतैेः ित
ृ ं निम्बबकरञ्जतैलं ससार्णपं स्त्रावहरं प्रददष्टम ् ॥३६॥
Prof. Siddhinandan Mishra- Bhaisajaya ratnawoli Karnrogadhikar
Chaukhambha Sanskrit Sansthan, Varanasi, Page number- 974
3) न्स्त्थते कफे स्त्रोतशस पपत्तिेजसा पवल्लायमािे िस
ू प्र
ं तापवाि

अवेदिो वाऽपप अथवा सवेदिो पि स्त्रवेत पूनतण च पूनतणकणणकेः ॥

Dr. Kaviraj Ambikadatta Shastri - Sushruta Samhita Uttartantra Chaukhambha

Sanskrit Sansthan, Varanasi, Reprint 2017, Page number 121, Verse Sushruta
Uttartantra 20/15.

4) "िादf} अनतरुकेः कणणमलस्त्य िोर्ेः स्त्रावेः तिुश्रवणं य वातात ्

िौफेः सरागों दरणं पवदाहेः सपूपवणस्त्रवणं च पपत्तात ् ॥

Dr.Bramhanand Tripathi - Charak Samhita Uttaradho-Chaukhambha

Surbharati Prakashan, Varanasi, Reprint 2006 Page Number 891, Verse –
Charak Chikitsasthan 26/127.

5) "कफो पवदग्धेः पपत्तेि सरुजं िीरुजं त्वपप

धि पूनतण बहू क्लेदं कुरुते पुनतकणणकम ् ॥

Dr. Ganesh Krishna Garde-Sarth Vagbhatta-Uttarsthan-Anmol Prakashan,

Pune, Reprint 2010, Page number 461 Verse - Vagbhatta Uttarsthan 17/12.

6) Website: www.sciencedirect.com V. Rupa, A Jacob, A Joseph-

International Journal of Paediatric Otorhinolaryngology. Elsevier Science
Ireland limited - Chronic Suppurative Otitis Media prevalence and
practices among rural South Indian Children dated 25 May 1999. - Page
no. 217 Visited on 1/2/2018.

26
 7) P.L. Dhingra Disease of Ear, Nose, and Throat and Head and Neck
Surgery - Elesivier-7th Edition Page number 74.

8) निगडुण िजानतरपविङ रसोिरम्बिा

कापाणसशिग्रस
ु रु स आद्रं ककारवेल्ल्येः।

एर्ां रसे नतलिवं सपवर्

सुकणणबधधयणिादशमवेदिपूवय
ण ुक्त ॥ 16

Dr.Indradev Tripathi, Dr.Dayashankar Tripathi Yogratnakar Karnaroga -

Chaukhambha Krishnadas Academy, Varanasi, Reprint 2007, Page number
733. Verse 52.

9) "जीवतती जलदे वदारुजलदत्वक सेव्यगोपीदहमम ्।

दावत्वगमधुकल्पवागुरुवरापुण्ड्रा बबल्वोत्पलम ् ॥

धावतया सुरशिेः न्स्त्थरै कुशमहर पर रुदटरे णुका

ककज्जल्कं कमलाद्धं ितगुणं ददव्येम्बिशस क्वाथयेत ् ॥

तैलास दिगुणं पररिेष्य तेि तैल पचेत च सशललेि दिणव वाराि ्।

पाs] क्षक्षपेश्च दिमे सममं अजदग्ु धं तस्त्य॑ महागण

ु ं उिन्तत अणत
ू ैलं एतत ्।।।

Kaviraj Atridev Gupta Ashtanghridayam Vidyotini teeka Chaukhambha

Prakashan Vaaranasi, Reprint 2008, Page number 176, Ashtnghriday
Surtasthan Verse 20/38.
10) घि निरततर वारं वारशमत्यथण ।

अतये घिशमती पूयस्त्थ पविेर्णमाहू

Yadavji Trikamaji Aacharya - Sushrut Samhita Dalhan Teeka-Krishnadas:

Academy, Varanasi, Reprint 1998, Page number 644, Verse Sushruta
Uttartantra 20/15.

11) अथ पुनतेः कणणपवद्रधध पाकात ् वा अम्बबूपूरण

पूयम ् स्त्रयनत वा पूनतण स ्ेय पनू तकणणकेः ॥

Dr. Indradev Tripathi, Dr. Dayashankar Tripathi-Yogratnakar - Karnaroga -

Chaukhambha Krishnadas Academy, Varanasi, Reprint 2007, Page number
729.

27
12) शिरोपवरे चि चैव धूपि पूरण तथा

प्रमाजणिं धाविं च वीक्ष्य वीक्ष्यावचारयेत

Dr. Kaviraj Ambikadatta Shastri -Sushruta Samhita Uttaradha -

Chaukhambhal Sanskrit Sansthan, Varanasi, Reprint 2017, Page number
131, Verse-Sushruta Uttartantra 21/40.

13) "धारयेतपूरणम अगे अमूलम पवमदण यि ।

रूजेः स्त्वातेः मादण वम यावत मारा ितमवेदिे॥'

Dr. Ganesh Krishna Garde-Sarth Vagbhatta-Sutrasthan - Anmol Prakashan,

Pune, Reprint 2010, Page number 104, Verse - Vagbhatta Sutrasthon 22/32.

14) "और्धम ् और्ध शसध्दो वा स्त्िेहो िाशसकभ्या दीयते इनत िस्त्यम ्

Dr. Kaviraj Ambikadatta Shastri - Sushruta Samhita Part 1 - Sanskrit

Sansthan, Varanasi, Reprint 2015, Page number 221, Verse-Sushruta
Chikitsasthan 40/21.

15) Shree Bramhashankar Mishra Bhavaprakasha Vidyotinee Teeka -

Chaukhambha Sanskrit Sansthan, Varanasi, Reprint 2004, Page number
344, Guduchyadi varga, Verse 113.

16) Shree Bramhashankar Mishra Bhavaprakasha Vidyotinee Teeka -

Chaukhambha Sanskrit Sansthan, Varanasi, Reprint 2004, Page number
491, Pushpa varga, Verse 28.

17) Shree Bramhashankar Mishra - Bhavaprakasha - Vidyotinee Teeka -

Chaukhambha Sanskrit Sansthan, Varanasi, Reprint 2004, Page number
303, Guduchyadi varga, Verse 72.

18) Shree Bramhashankar Mishra Bhavaprakasha Vidyotinee Teeka -

Chaukhambha Sanskrit Sansthan, Varanasi, Reprint 2004, Page number 426
Guduchyadi varga, Verse 240.
19) Shree Bramhashankar Mishra - Bhavaprakasha Vidyotinee Teeka -
Chaukhambha Sanskrit Sansthan, Varanasi, Reprint 2004, Page number
131, 17) Haritakyadi varga, Verse 219-220.

28
20) Shree Bramhashankar Mishra - Bhavaprakasha - Vidyotinee Teeka -
Chaukhambha Sanskrit Sansthan, Varanasi, Reprint 2004, Page number
556, Aamradiphala varga, Verse 37.

21) Shree Bramhashankar Mishra - Bhovaprakasha - Vidyotinee Teeka -

Chaukhambha Sanskrit Sansthan, Varanasi, Reprint 2004, Page number
374, Guduchyadi varga, Verse 151-152

22) Shree Bramhashankar Mishra - Bhavaprakasha Vidyotinee Teeka -

Chaukhambha Sanskrit Sansthan, Varanasi, Reprint 2004, Page number
336, Aamradiphala varga, Verse 110.

23) Shree Bramhashankar Mishra Bhovaprakasha - Vidyotinee Teeka -

Chaukhambha Sanskrit Sansthan, Varanasi, Reprint 2004, Page number
506, Pushpa varga, Verse 63.

24) Shree Bramhashankar Mishra - Bhovaprakasha Vidyotinee Teeka -

Chaukhambha Sanskrit Sansthan, Varanasi, Reprint 2004, Page number
14, Haritakyadi varga, Verse 49.

25) Shree Bramhashankar Mishra Bhavaprakasha Vidyotinee Teeka -

Chaukhambha Sanskrit Sansthan, Varanasi, Reprint 2004, Page number
683, Shaak varga, Verse 63.

26) Shree Bramhashankar Mishra Bhavaprakasha Vidyotinee Teeka -

Chaukhambha Sanskrit Sansthan, Varanasi, Reprint 2004, Page number
854, Verse 253.

27) Dr. Kaviraj Ambikadatta Shastri - Sushruta Samhita Part 1 Chaukhambha

Sanskrit Sansthan, Varanasi, Reprint 2015, Page number 229-230, Verse -
Sushruta Sutrasthan Verse 45/112-113.

29
Time

Apr 2022
Dec

Apr 2023
May
Feb 2022

Mar 2022

Feb 2023

Feb 2023

Mar 2023

Mar 2023
Jan 2022

Jan 2023

Jun 2023
(Months)

2023
2022
Task

to

to
Development of
CRF
Introduction writing
Review of literature
Selection of
patients
Start of clinical
study
Data collection
Data classification
and summarization
Observation and
result
Discussion and
Conclusion
Submission

30
 10. Annexures

10.1. Written consent

POST GRADUATE DEPARTMENT OF SHALAKYA TANTRA

Written Consent Form

“A Randomized Controlled Clinical Study Of Efficacy Of Jambvadi Taila

Karnapoorna In Karna Srava With Special Reference To Chronic
Suppurative Otitis Media”

Myself, Mr/Mrs……………………………………………………….

Age/Sex……………..

About exercising my free power of choice; hereby give my consent to be

included as a subject in the clinical trial of Jambvadi Taila
Karnapooran. I understand that, I have to follow the Lifestyle guidelines
as per advised by physician.

All aspects including the nature of treatment follow up including various

investigations to monitor and safe guard of my health and possible
complications have been informed, to my satisfaction by the attending
physician for the purpose of the clinical trials. I have not offered any type
of reward or money to participate. I am also aware of my right to
discontinue the trials at any stage during the course of study without
giving any reasons. I give my consent without any botheration to include
in clinical trials of Jambvadi Taila Karnapooran.

Signature/Thumb impression Signature/Thumb impression

of wittiness
of Patient

Signature of P.G. Student

Date:

31
 POST GRADUATE DEPARTMENT OF SHALAKYA TANTRA DEPT

लेखी संमतीपत्र

“A Randomized Controlled Clinical Study Of Efficacy Of Jambvadi Taila

Karnapoorna In Karna Srava With Special Reference To Chronic
Suppurative Otitis Media”

मी. श्री/सी……………………………………………………………..

वय/शलंग_...................

माझ्या मजीिे च स्त्वखि

ु ीिे असे शलहूि दे तेकी, मी निगि
ुण यादद तैल
कणणपरू ण आणण अणु तैलया संिोधिात्मक अभ्यासामध्ये सहिागी होण्ड्यासाठी
तयार आहे . त्यासाठी धचककत्से संबन्तधकाही नियम पाळावे लागतील हे सुद्धा
मादहती आहे .

धचककत्से संबंधीचे नियम, त्यासंदिाणत वेळोवेळी कराव्या लागिायाण माझ्या

आरोग्यीय तपासण्ड्या आणण संिाव्य धोके या सवांची मला स्त्पष्ट कल्पिा ददली
ण णे समजली आहे . मला कोणत्याही प्रकायाण बक्षक्षसाचे ककंवा
आहे व ती मला पूणप
इतर आशमर् दाखवण्ड्यात आले िाही.

मला हे सुद्धा मादहत आहे कक, मी कोणतेदह कारण ि दे ता या प्रकियेतूि

बाहे र पिू िकते व तो माझा अधधकार आहे.

मी कोणत्याही दबावाला वा आशमर्ाला बळी ि पिता निगुणियादद तैल

कणणपूरण आणण अणु तैलग्या संिोधिात्मक अभ्यासामध्ये सहिागी होण्ड्यासाठी
माझी पूणण सहमती दिणवते.

रुग्नाची सही साक्षीदाराची सही

पी. जी. विद्यार्थी

ददनांक
32
10.2. Case record form

Name:……………………………………………………….

Age:……… yrs.

Sex:…………

Occupation:………………..

Address:…………………………………………………….
………………………………………………………………

O.P.D. No………………. I.P.D. No………………..

DATE OF ADMISSION:………… DATE OF DISCHARGE:………

Chief complaints Duration

1. Discharge in ear Rt/Lt/Bil

2. Pain in Ear Rt/Lt/Bil

3. Itching in Ear Rt/Lt/Bil

4. Loss of hearing Rt/Lt/Bil

5. Other

Rugna Itihas:
1) History of:
Swimming:
Ear scratching:
Other

2) H/O Present illness:

3) H/O Past illness:

D.M., H.T.N., Koch's, B.A. etc

Operatives -

Allergy to -
4) H/O trauma:

5) Family History:
33
6) Personal History
a) Aahar: Veg/Non-Veg

b) Vihar: Swimming/Cold Exposure

c) Addiction:

Examination of Patient:

Ashtavidha Parikshan:

1) Nadi 5) Shabda

2) Mala 6) Sparsha

3) Mutra 7) Druka

4) Jivha 8) Aakruti

Local Examination:

1) External Ear: Rt Lt

a) Pinna
b) Tragus
c) Post aural area

External Auditory Canal:

1) Cavity/Lumen:

a) Nature of discharge: Mucoid/ Mucopurulent / Purulent

b) Amount of discharge: Mild / Moderate / Severe

c) Congestion of canal wall Yes/No
d) Wax Yes/No

2) Tympanic membrane: Visible / Not visible

Normal and cone of light seen
Congested/Retracted
Perforation central/irregular/marginal/ kidney
shaped/total

34
 Lymphadenopathy: Preauricular/infraauricular/Postauricular
Enlarged/palpable/tender/inflammed

Middle Ear: Redness in middle ear mucosa

With/without oedematous Tympanic
membrane
With/without Otitis Externa

1) Tunning fork test: Rt/Lt

Rinne's Test

Weber's Test

Hearing impairment Mild/Moderate/severe

Examination of Nose:

External Nose

Nasal cavity Rt Lt

Nasal mucosa cong/no cong cong/no cong

Turbinate hyp/no hyp hyp/no hyp

Septum

Oral Cavity

1) Teeth 4) Tonsils

2) Gums 5) larynx

3) Tongue

Investigation:

1) T.L.C

2) D.L.C

3) B.S.L(R)

4) Urine-Routine and Microscopic

35
 Dosh-Dushya:

1) Dosh

2) Dushya

Dignosis:

TREATMENT:

• Group A: Jambvadi Taila Karnapooran.

 Group B:Chloromphenicol (0.4% ) + Polymyxin B Sulphate ear drop.

Pathya apathya:

Avoid Swimming, Avoid Ear scratching.

Follow up during treatment:

Sign and Symptoms 1st day 7th 15th 30th
Nature of discharge
Earache
Hearing impairment
Perforation
Inflammation
Amount of discharge

P.G. SCHOLAR GUIDE

36