INFORMED CONSENT FORM

FOR PARTICIPATION IN CLINICAL STUDY

Study Title:Age Group.

INTRODUCTION:
Lower respiratory tract infection (LRTI) is infection below the level of the larynx and may be
taken to include bronchiolitis, bronchitis and pneumonia. The presentation of these conditions
will depend on age, infecting organism and site of infection.1

Recurrent lower respiratory tract infection can be regarded as ≥3 annual episodes of documented
bronchitis, bronchiolitis, or pneumonia.

The paediatric age group suffers more frequently in lower respiratory tract infection (LRTI).
LRTI is the 5th leading cause of death & the combined leading cause of death, being responsible
for 2.74 million deaths (95% uncertainty interval [IU] 2.50million to2.86 million) worldwide.2
The most common organism responsible for LRTI disease is Streptococcus pneumonia in 90% of
all cases.3

The common clinical presentations of LRTI disease are fever, rigors, shivering, malaise, loss of
appetite, headache, tachypnea, cough which is short, painful & dry but later accompanied by the
expectoration of muco-purulent sputum.4

In modern medicine, the primary prevention of pneumococcal disease is by pneumococcal

vaccine and treatment is via antibiotics. Pneumococcal vaccine is costly & the vaccine is not
under the National Immunisation Schedule & may cause harmful side effects.

Homoeopathy may offer a better alternative treatment in case of recurrent LRTI in paediatric age
group. Pneumococcinum is a nosode. The clinical information described in homoeopathic
literature suggest the adaptability and very efficacious role in LRTI.2 But, till now no significant
proving and clinical trial has been done.
In light of this same analogy, individualization of the patient usually not needed.
Pneumococcinum 200CH is administered in this trial not on the basis of Similimum but on the
basis of “Generic similarity”.

Present study will evaluate how efficacy of Pneumococcinum 200CH modifying considerable
side effect in paediatric age group in a Govt. Medical College & Hospital.

OBJECTIVES:

To evaluate the efficacy of Pneumococcinum 200 CH in the diminishing the mean frequency of
attack, duration of attack and severity of attack in recurrent LRTI according to the CGI scale.

METHODOLOGY:

1. Study place: In a Govt. Medical College & Hospital in WB.

2. Study setting:

2.1. O.P.D. and I.P.D of Government Medical College and hospital of W.B

2.2 Other sources (If possible)

3. Study period: About 6 months.

4. Sample size: Not less than 36 cases.

5. Sample Design: Patient of paediatric age group (1-12 years) randomized by random
number table.

6. Selection criteria:

6.1. Inclusion criteria:

 6.1.1. Subject suffering from group of
symptom stated in the introduction
and having recurrent history of
Lower Respiratory Tract Infections
( ≥3 annual episodes of
documented bronchitis,
bronchiolitis, or pneumonia).

6.1.2. Patients in the age group 1-12

years of age.

6.1.3. Subjects of both sexes.

6.1.4. Subjects of all religions.

6.2. Exclusion criteria:

6.2.1. Subjects suffering from severe life-

threatening illness of respiratory
origin (including LRTI) of such a
nature requiring immediate
hospitalisation.

6.2.2. Pneumococcal vaccinated child

6.2.3. Subjects suffering from symptoms

of immune-compromised state.

6.2.4. Patients unwilling to participate in

this study.

6.2.5. Subjects already taking

Homoeopathic medicine or of any
other system.
7. Study tools:

7.1. Drugs – Pneumococcinum, procured from GMP Certified Company.

7.2. Potency – 200 CH.

7.3. Case taking proforma.

7.4. Patient Informed Consent Form.

7.5. Diet & regimen – Normal nutritious diet & regimen as homoeopathic
principle & philosophy.

7.6. CGI scale.

8. Route of Administration: Oral will be chosen.

9. Study technique: Prospective, non-randomized, open label study.

10. Study procedure:

10.1. Information is collected from standard books & Journals about recurrent
LRTI, & Pneumococcinum (Homoeopathic medicine)

10.2. Informed consent will be obtained from all patients before taking in this
study who have fulfilled the inclusion and exclusion criteria.

10.3. Preliminary case taking with incorporated the bio-data including age, sex,
clinical examination & investigation to confirm the presence of recurrent
LRTI.

10.4. Selection of 36 patients (minimum) after fulfilment of inclusion &

exclusion criteria. Initial screening will be done in 36 patients presenting
with clinical features of LRTI for inclusion and exclusion criteria.

10.5. Proper case taking will be done according to standard case taking proforma
supplied by the Institution following Homoeopathic Principle &
Philosophy.
 10.6. Relevant clinical examination & investigations will be done as per needed.

10.7. Initial assessment will be done noting the mean frequency and duration of
past attacks and severity of present attack (by CGIS).

10.8. Homoeopathic medicine (Pneumococcinum 200 CH) will be given to

patients according to study design.

10.9. Proper follow up and relevant investigations will be done at 14 days

interval for a minimum of 2 months.

10.10. After completion of two months outcome will be assessed as per the set
parameters.

10.11. Result will be analysed and represented by statistical method to conclude

the study.

REFERENCES

1. Lower Respiratory Tract Infection in Children | Doctor [Internet]. Patient.info. 2018 [cited
4 August 2018]. Available from: https://patient.info/doctor/lower-respiratory-tract-
infection-in-children.

2. De Benedictis FM, Bush A. Recurrent lower respiratory tract infections in children. BMJ
[Internet]. BMJ; 2018 Jul 12;k2698. Available from: http://dx.doi.org/10.1136/bmj.k2698

3. Walker B.R.(ed.), Colledge N.R.(ed.),Ralston S.H.(ed.),Penman I.D.(ed.); Davidson's

principles and Practice of Medicine; 22nd Edition; Edinburgh; Churchill Livingstone
Elsevier;2014;p.682

4. Mohan H; Text Book of Pathology;7th Edition, New Dellhi,India;Jaypee;2015;p.449

 5. Walker B.R.(ed.), Colledge N.R.(ed.),Ralston S.H.(ed.),Penman I.D.(ed.); Davidson's
principles and Practice of Medicine; 22nd Edition; Edinburgh; Churchill Livingstone
Elsevier;2014;p.683

6. Julion O.A., Materia Medica of Nosodes With Repertory;2nd Revised Edition 1985;
New Delhi; India; B.jain Publishers (P) Ltd. 2003;p.452,454,4575

7. Estimates of the global, regional, and rational morbidity, mortality, aetiologies of

lower respiratory tract infections in 195 countries: a systemic analysis for the Global
Burden of Disease Study 2015- The Lancet Infectious Diseases;Volime 17,issue 11,
November 1,2017. DOI:https://doi.org/10.1016/S1473-3099(17)30396-1.

Subject’s Initials: ___________________ Age: _____ Sex: ______

Date of birth: __________________

1. I confirm that I have read and understood the information sheet for the above study. I have had
the opportunity to ask questions and all my questions and doubts have been answered to my
complete satisfaction.
2. I understand that my participation in the study is voluntary and that I am free to withdraw at
any time, without giving reasons, without my relationship with the attending physicians being
compromised or my legal rights being affected.
3. I understand that my identity will not be revealed in any information released to third parties
or published, unless as required under the law. I agree not to restrict the use of any data or results
that arise from the study.
4. I agree not to withhold any information about my health from the investigator and will convey
the same truthfully.
5. I agree to my taking part in the above study and to comply with the instructions given during
the study and to cooperate with the study team.
6. I give my consent to my undergoing a complete physical examination as specified in the study
protocol and explained to me.
Signature / thumb impression of the subject: ________________________________
Name and address: ____________________________________________________
Signature of witness: __________________________________________________
Name and address: _____________________________________________________
Investigator’s name and Signature: _______________________________________
Place _________________ Date _______