Drug proving Project PROl- Investigations to be

done

Sr no. Blood Investigation to be Sample to be

done pre and post collected

1. Hb

2. TLC

3. DLC

4. ESR

5. Platelet count
-

6. Peripheral smear

7. Blood Gluocse Fasting

8. Bilirubin (Direct)

9. Bilirubin (Indirect)

10. T. Bil irub in

11. SGOT

12. SGPT

13. Alk . Phosphatase

14. Album in
(
15. Globulin

16. A/G ratio

17. S. creatinine

18. S. urea

19. Total protein

20. URIC ACID

21. T3

I
22. T4

23. TSH

Urine Examination

24. Routine Examination

25. Microscopic examination

Stool Examination

26. Routine Examination

27. Microscopic examination

28. X Ray chest ---once

29. ECG ---once

30. Any other in case required

J
 I
'"11v': , ; j,\JP-~

vcJ)d - p,.
Reference No.: MLDMHl/PAL/M 11: 173/2019 Q)'f}-tO
KA Pf.-0 I froJ«t ·
To,
Dr. Rajesh Shah,
Principal Investigator - Drug Proving EMT ACT project
Life force Centre
Sub: Approval of Research Proposal of Entitled "Homoeopathic Drug Proving:
Randomized Double Blind Placebo Controlled Trial of EMT ACT'
Ref: - Your letter dated 7'" March, 2019
(Letter & Proposal of Dr. Rajesh Shah. Life force Ltd. Presented by Dr. Prashant
Tamboli.)

Dear Dr. Rajesh Shah,

The above mentioned research proposal was discussed in the Ethics Committee
meeting held on 22/03 /2019 at Dr. M. L. Dhawalc Memorial Homoeopathic Institute,

Palghar.
The following documents were reviewed and discussed:
I. Homoeopathic Drug Proving: Randomized Double Blind Placebo Controlled Trial

of EMT ACT version I. I

2. Application Fonn (Form A)
3. Prover's Information Sheet (Form B 1)
4. Written Information Sheet (Form B2)
5. Screening Form (Form C)
6. Pre - trial Medical Examination form (Form D - Part I - 111) '\

7. Prover's Day Book Proforma (Form E) 1\

8. Symptom Elaboration Form (Forni F) \\

9. Adverse Event Reporting Proforma

Ethics Committee has unanimously approved your Research Proposal along with al\
the forniats . You are advised to inform the progress of the project and incase of any

adverse event.
l ,
~ R . MIHJ~ARJKH
Chairperson. Ethics Committee
Dr. M. L. Dhawale Memorial Homoeopathic Institute, Palghar
\

j
I CLINICAL TRIALS REGISTRY - INDIA
ICMR • Notional lnstihrte o! Modlcal StatisUcs PDF of Trial
CTRI Website URL - http://ctri.nic.in

CTRI Number
CTRl/2019/12/022521 [Registered on: 26/12/2019)-Trial Registered Prospectively
Last Modified On 24/12/2019
Post Graduate Thesis No
Type of Trial lnterventional
Type of Study Drug
Homeopathy
Study Design
Randomized, Parallel Group, Placebo Controlled Trial
Public Title of Study
Study to observe clinical symptoms of PRO1 in healthy volunteers.
Scientific ntle of
Study Homoeopathic drug proving: Randomized double-blind placebo-controlled trial of PRO1
Secondary IDs if Any Secondary ID ...
.
a
.. .Sic Jde,:itif!ir, ., ,'11' ... ~!\cl..
LFFT/MLD/PRO12019-Version_1.3_date_12th_J
une 2019 Protocol Number
Details of Principal
Investigator or overaII Details o.f Prinblpal lnves!igator .".[;;'
Name I!!
Trial Coordinator Rajesh Shah
(multi-center study) Designation
Principal Investigator
Affiliation
Life Force Foundation trust
Address
Department- Research Room no. 411, Krushal commercial complex,
G M Road, Chembur Mumbai Site Address: Department- Research
Smt Malini Kishore Sanghvi Homoeopathic Medical College,
Vadodara
Mumbai
MAHARASHTRA
400089
India
Phone 09820536522
Fax
Email sanjivak@gmail.com
Details Contact
Person (Scientific Details ContactPerson' (Scjentific.rQuecy) .
Query) Name Rajesh Shah '
Designation Principal Investigator
Affiliation Life Force Foundation trust
Address
Department- Research, Room No. 411, Krushal commercial
complex, G M Road, Chembur Mumbai Site Address: department
Research, Sm! Mallni Klshore Sanghvi Homoeopathic Medical
College, Vadodara
Mumbai
MAHARASHTRA
400089
India
Phone 09820536522
Fax
Email sanjlvak@gmail.com
Details Contact
Details Contact Person (Public Query)
Person (Public Query)
Name Rajesh Shah
Designation Principal Investigator
Affiliation Life Force Foundation Trust
Address Department- Research Room No. 411 , Krushal commercial complex,
G M Road, Chembur Mumbai Site Address: Department- Research

page 1 /4
 Sml Malini Kishore Sanghvi Homoeopathic Medical College,
Vadodara
Mumbai
MAHARASHTRA
400089
India
Phone 09820536522
Fax
Email sanjivak@gmail.com
Source of Monetary or
Material Support Source of Mone!;!_ry or !J(aterial Support
> life Force Foundation Trust 411, Krushal commercial complex, GM Road, Chembur Mumbai
Primary Sponsor

Name
Primary Sponsor Details
life Force Foundation Trust
"' •·
Address
411 Krushal Commercial Complex, Chembur, Mumbai 400089. India
Type of Sponsor
Other [Trust]
Details of Secondary
Sponsor
IL /Address
Countries of IL
Recruitment &,st of Countries
dia
Sites of Study
Name' of Principal Name of Site~ '
lnve.stigator ,. SiJe Alfdress Phone/Fax/Email
Ill ,.~ " ;;
Dr Rajesh Shah .
Smt Malini Kishore Department of research 09820536522
Sanghvi Homoeopathic in Homeopalhy
Medical College Division- Homeopalhy sanjivak@gmail.com
Room No.10 Sm! Mallni
Kishore Sanghvi
Homoeopathic Medical
College For life Force,
Karjan, Vadodara,
Gujarat 391240
Vadodara
GUJARAT
Details of Ethics
Name of Committee Approval Status
Committee Date of,Approval ' 1~s Independent Ethics
._, ·•· . Gommittee?a
DrM LDhawie Approved 09/12/2019 No
Memorial Homeopalhic
lnstilute
Regulatory Clearance Status
Status from DCGI Date . .
Not Applicable
No Dale Specified
Health Condition I Health Type . Condition
Problems Studied
Healthy Human Volunteers
"'
Heallhy Human Volunteers
Intervention I Type Name
I
Comparator Agent Details
Intervention PRO1
PRO1 30c pills Dose: 4 pills
daily for 4 weeks.
Comparator Agent Placebo
Placebo pills Dose: 4 pills daily
for4 weeks.
Inclusion Criteria
Inclusion Criteria
Age From 18.00 Year(s)
Age To 60.00 Year(s)
Gender Both

page2/4
 ' I n
CLINICAL TRIALS REGISTRY - INDIA
PDF of Trial
ICMR . National Institute of Medical Statistics
CTRI Website URL - http://ctri.nic.in

Details 1.Healthy individuals with no apparent disease and normal routine

laboratory parameters during screening
2.lntelligenl enough to record carefully the facts, subjective and
objective symptoms generated by the drug during proving.
3.Able lo be informed of the nature of the study and willing to give
written informed consent

$.
Exclusion Criteria 4
Exi;lusion Criteria
Details 1.Any disease or condition which might compromise the
hematopoietic, renal, endocrine, pulmonary, central nervous system,
cardiovascular, immunological, dermatological, gastro-intestinal or
any other body system
2.Persons with colour blindness.
3.Persons who have undergone surgery in last two months.
4.Pianned medical / dental treatment during the proving period
including herbal or dieta,y supplements, procedures, or medications
that are likely to interfere with, or substantially alter, responsiveness
lo the proving substance.
5.Volunteers on regular medication (allopathic, ayurvedic,
homoeopathic, naturopathic, unani, etc.) for any acute or chronic
disease.
6.Participant must not be on any homoeopathic remedy in the
preceding one month and have had no significant change in health
status in last one month.
7.Emotionally disturbed, hysterical or anxious persons.
a.Persons having known history of allergies, food hypersensitivity,
etc.
9.Women during pregnancy, puerperium and while breast-feeding.
10.Smokers who smoke more than 10 cigarettes per day
11 .Recent history of alcoholism / drug addictions or unlikely to refrain
from excessive alcohol consumption / drug intake during the study
period
12.Participation in another clinical or proving trial during the last 6
months

Method of Generating Computer generated randomization

Random Sequence
Pre-numbered or coded identical Containers
Method of
Concealment
Blinding/Masking Participant and Investigator Blinded <

Ti!ilepolnts
Primary Outcome Outcome '
Symptoms experienced by provers will be
Symptoms experienced by provers will be
recorded daily and will be analyzed al the end of
recorded. trial (9 week) period .

,, Time points
Secondary Outcome Outcome
Pre( screening) and post (after completion of 4
Safety parameters - including blood
doses of proving substance)
investigations ECG and X ray,

Target Sample Size Total Sample Size=30

Sample Size from lndia=30
Final Enrollment numbers achieved (Total)=Applicable only for Completed/Terminated trials
Final Enrollment numbers achieved (lndla)=Applicable only for Completed/Terminated trials

Phase of Trial N IA
Date of First 26/12/2019
Enrollment (India)
No Date Specified
Date of First
Enrollment (Global)
Estimated Duration of Years=1

page3/4
 -- -- . ff 1f>,,., ~"'',1 P ;' ' ;· 'J .1 ·' ·~ - ·· • -
\
':'¥, i, PDF of Trial
CLI NICAL TRJALS REGISTRY • INDIA .~ ·· CTRI Website URL - http://ctri.nic.in
'\
ICMR. Nation al Institute of Medical Statistics '41>' ··.:
D -~
Trial Months=O
Days=O
Recruitment Status of Not Applicable
Trial (Global)
Recruitment Status of Not Yet Recruiting
Trial (India)
Publi~ation Details Currently not available
Brief Summary The aim of a Homeopathic drug Proving is to gain knowledge about this
innate character of a drug, the "remedy picture", which is more an aspect
of quality, than of quantity. We prove a substance not for the proof of an
effect, but in the sense that we test its qualities. Thus, a Homeopathic
Drug proving is an investigation, which is designed to gather information
on the potential areas of application for Homeopathic remedies.
page 414
 1
SMT. MALINI KISHORE SANGHVI HOMOEOPATHIC MEDICAL COLLEGE & HOSPITAL
A UNIT OF: DR. M. L. DHAWALE MEMORIAL HOMOEOPATHIC INSTITUTE

1st NABH accredited Homoeopathic Hospital in Gujarat

CONSENT FOR URINE PREGNANCY TEST

Date: _ _ _ __

I, _ _ _ _ _ _ _ _ _ _ _ _ _ __, Age: _ _ _ _ Sex: _ _ __

have understood the need for conducting a Urine Pregnancy Test [UPT] for my
Volunteer participation in "Drug Proving Programme - PROl" and willingly
providing my Urine Sample.

I have been explained and I have understood that my UPT report will be
confidential.

Name of the Volunteer: _ _ _ _ _ __

Signature of the Volunteer: _ _ _ _ _ __

Date & Time of Sign: _ _ _ _ _ _ _ __