| CTRI Number |
CTRI/2024/03/064444 [Registered on: 19/03/2024] Trial Registered Prospectively |
| Last Modified On: |
23/07/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Drug proving of homoeopathic drug substance to understand its medicinal effects. |
|
Scientific Title of Study
|
Homoeopathic Drug Proving of Drug Code 161: A Multicentre, double blind, randomized placebo controlled trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pritha Mehra |
| Designation |
Scientist- III |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Central Council for Research in Homoeopathy
61-65 Institutional Area Opp. D-Block Janakpuri New Delhi-110058
South West
DELHI
110058
India |
| Phone |
9999036871 |
| Fax |
|
| Email |
ccrhdp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pritha Mehra |
| Designation |
Scientist- III |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Central Council for Research in Homoeopathy
61-65 Institutional Area Opp. D-Block Janakpuri New Delhi-110058
DELHI
110058
India |
| Phone |
9999036871 |
| Fax |
|
| Email |
ccrhdp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pritha Mehra |
| Designation |
Scientist- III |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Central Council for Research in Homoeopathy
61-65 Institutional Area Opp. D-Block Janakpuri New Delhi-110058
DELHI
110058
India |
| Phone |
9999036871 |
| Fax |
|
| Email |
ccrhdp@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Homoeopathy
61-65 Institutional Area Opp. D-Block Janakpuri New Delhi-110058
|
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Homoeopathy |
| Address |
Central Council for Research in Homoeopathy
61-65 Institutional Area Opp. D-Block Janakpuri New Delhi-110058
|
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 13 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Uttam Singh |
Central Research Institute of Homoeopathy, Jaipur |
Sector-26, Pratap Nagar, Jaipur-302033, Rajasthan
Jaipur
RAJASTHAN |
9899144235
druttam01@gmail.com |
| Dr Madhumita Sadhukhan |
Dr. Anjali Chatterji Regional Research Institute for Homoeopathy, Kolkata |
50, Rajendra Chatterjee Road, Kolkata-700035
Kolkata
WEST BENGAL |
9331866008
dr.msadhukhan@gmail.com |
| Dr Sonia Raizada |
Dr. D.P.Rastogi Central Research Institute of Homoeopathy, Noida |
A-1/1, Sector-24, Noida,Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH |
9717213679
drsoniaraizada@gmail.com |
| Dr Meera Shah |
Dr. V.H. Dave Homoeopathic Medical College, Anand |
Department of Repertory, Hahnemann House Amul Dairy Road Anand Gujarat India
Anand
GUJARAT |
9898692003
dr.meerashah@yahoo.com |
| Dr Umakanta Prusty |
Drug Proving Unit, Bhubaneswar |
Dr. Abhin Chandra Homoeopathic Medical College & Hospital, Unit 3, Kharvel Nagar, Bhubaneswar -751001, Odisha
Khordha
ORISSA |
9485025977
druprusty@gmail.com |
| Dr Meeta Patel |
Gujarat Homoeopathic Medical College and Hospital |
Department of Obs & Gynae Near Old Bus Stand, Muval Road, Savli, Gujarat
Vadodara
GUJARAT |
9426761488
pateldrmeetav@gmail.com |
| Dr Ashwin Shrikant Kulkarni |
Late Mrs. Housabai Homoeopathic Medical College & Hospital |
Department of
Practice of Medicine,
Sangli-Kolhapur Road,
A/p: Nimshirgaon, Tal:
Shirol Dist: Kolhapur,
416101
Kolhapur,
MAHARASHTRA
Kolhapur
MAHARASHTRA |
8928981777
k.ashwin25@gmail.com |
| Dr Kaushal Kumar Savera |
National Homoeopathy Research Institute in Mental Health, Kottayam |
Sachivothamapuram PO, Kottayam - 686532 (Kerala)
Kottayam
KERALA |
8820804665
drkksavera@gmail.com |
| Dr Kishan Banoth |
Regional Research Institute of Homoeopathy, Gudivada |
Dr.GGH Medical college Campus,Eluru Road, Gudivada - 521 301
Krishna
ANDHRA PRADESH |
9000394815
drkbanoth@gmail.com |
| Dr Amulya Ratna Sahoo |
Regional Research Institute of Homoeopathy, Guwahati |
Ground Floor, Old Building of CARI for GID (Ayurvedic Campus), Borsojai, P.O. Beltola, Guwahati- 781028
Kamrup
ASSAM |
8763721546
drarsahoo@gmail.com |
| Dr Rompicherla GR Kiranmayee |
Regional Research Institute of Homoeopathy, Hyderabad |
OUB 32, Street no. 4, Vikrampuri, Habsiguda, Hyderabad
Hyderabad
TELANGANA |
9030185002
drgrkiranmayee@gmail.com |
| Dr Birendra Singh Rawat |
Regional Research Institute of Homoeopathy, Navi Mumbai |
Plot No. 38 & 39, Sector18, Kharghar, Navi Mumbai 410210
Mumbai
MAHARASHTRA |
8080483012
rawatdrbirendrasingh@yahoo.co.in |
| Dr Sreeja S |
Sarda Krishna Homoeopathic Medical College and Hospital |
Department of Pharmacy, Kulasekharem, Kanniyakumari Dist, Tamil Nadu, PIN - 629161
Kanniyakumari
TAMIL NADU |
9496225218
drsreejasivanandan@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 16 |
| Name of Committee |
Approval Status |
| Central Ethics Committee |
Approved |
| Father Muller Institutional Ethics Committee |
Approved |
| Institutional Ethical Committee Bhubneshwar |
Approved |
| Institutional Ethical Committee Dr. V.H. Dave Homoeopathic Medical College, Anand |
Approved |
| Institutional Ethical Committee Goa |
Approved |
| Institutional Ethical Committee Gudivada |
Approved |
| Institutional Ethical Committee Guwahati |
Approved |
| Institutional Ethical Committee Hyderabad |
Approved |
| Institutional Ethical Committee Jaipur |
Approved |
| Institutional Ethical Committee Kolkata |
Approved |
| Institutional Ethical Committee Kottyam |
Approved |
| Institutional Ethical Committee Late Mrs. Housabai Homoeopathic Medical College & Hospita |
Approved |
| Institutional Ethical Committee Navi Mumbai |
Approved |
| Institutional Ethical Committee Noida |
Approved |
| Institutional Ethical Committee, Gujrat Homoeopathic Medical College and Hospital |
Approved |
| Institutional Ethical Committee, Sarada Krishna Homoeopathic Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Drug Code 161 |
To be administered in 6C, 12C, 30C and 200C potencies. 12 doses for each potency, frequency- four times a day for a maximum of 3 days, route of administration- oral. |
| Comparator Agent |
Placebo |
Optically identical to the interventional drug substance with the same dosage schedule. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age : 18 – 60 years.
Both males and females.
Healthy individuals with no apparent disease and normal routine laboratory parameters during screening.
Intelligent enough to record carefully the facts, subjective and objective symptoms generated by the drug during proving.
Able to be informed of the nature of the study and willing to give written informed consent.
|
|
| ExclusionCriteria |
| Details |
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.
Persons with colour blindness.
Persons who have undergone surgery in last two months.
Planned medical / dental treatment during the proving period including herbal or dietary supplements, procedures, or medications that are likely to interfere with, or substantially alter, responsiveness to the proving substance.
Volunteers on regular medication (allopathic, ayurvedic, homoeopathic, naturopathic, unani, etc.) for any acute or chronic disease.
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.
Emotionally disturbed, hysterical or anxious persons.
Persons having known history of allergies, food hypersensitivity, etc.
Women during pregnancy, puerperium and while breast-feeding and women who have undergone hysterectomy.
Smokers who smoke more than 10 cigarettes per day.
Recent history of alcoholism / drug addictions or unlikely to refrain from excessive alcohol consumption / drug intake during the study period.
Participation in another clinical or proving trial during the last 6 months.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The pathogenesis of this drug substance 161 |
Approximately 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is a double blind
randomized placebo control clinical trial to see the pathogenetic effect of the
investigational drug substance on healthy volunteers. The drug has to be proved
in ascending potencies. The drug is administered after PME and 1-2 weeks
run-in-period. The provers are advised to take 4 doses in a day (4 hourly)for 3
days from the prescribed batch (potency) of the coded drug. After the
completion of the batch(potency), one month washout period will be maintained
in all provers, before the next batch (potency) is initiated. After finishing
all the batches (potencies), the provers will undergo Post Trial Medical
Examination. The codes will be broken after the completion of the study and
data will be compiled to know the pathogenesis of this drug substance and analysed
to find characteristic symptom (prescribing indication). The proving symptoms
will be identified and segregated from the symptoms produced in placebo group.
The proving symptoms will from the drug pathogenesis. |