| CTRI Number |
CTRI/2020/11/028977 [Registered on: 09/11/2020] Trial Registered Prospectively |
| Last Modified On: |
08/11/2020 |
| 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 |
|
Scientific Title of Study
|
Homoeopathic Pathogenetic Trial of drug code 144: a multicenter, double blind, randomized, placebo controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anil Khurana |
| Designation |
Director General |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Central Council for Research in Homoeopathy 61-65 Institutional Area opp. D Block Janakpuri New Delhi Under Ministry of AYUSH South West DELHI
61-65 Institutional Area opp. D Block Janakpuri New Delhi Under Ministry of AYUSH
South West
DELHI
110058
India |
| Phone |
9911127619 |
| Fax |
|
| Email |
anil23101961@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pritha Mehra |
| Designation |
Research Officer (H)/ Scientist-2 |
| Affiliation |
Dr. D P Rastogi Central Research Institute for Homoeopathy |
| Address |
Room No. 112, Drug Proving Section Dr. D P Rastogi Central Research Institute for Homoeopathy A 1/1 Sector 24, Noida (UP) Gautam Budh Nagar
A 1/1 Sector 24, Noida (UP)
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9999036871 |
| Fax |
|
| Email |
drpritha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pritha Mehra |
| Designation |
Research Officer (H)/ Scientist-2 |
| Affiliation |
Dr. D P Rastogi Central Research Institute for Homoeopathy |
| Address |
Room No. 112, Drug Proving Section Dr. D P Rastogi Central Research Institute for Homoeopathy A 1/1 Sector 24, Noida (UP) Gautam Budh Nagar
A 1/1 Sector 24, Noida (UP)
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9999036871 |
| Fax |
|
| Email |
drpritha@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 |
61-65 Institutional Area D Block, Janakpuri, New Delhi |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashish Mahajan |
Central Research Institute for Homoeopathy |
Sector 26, Pratap Nagar, Jaipur- 302033 RAJASTHAN
Jaipur
RAJASTHAN |
8527266606
aashishmahajan@ccrhindia.nic.in |
| Dr P S Chakraborty |
Dr Anjali Chatterji Regional Research Institute for Homoeopathy |
50, Rajendra Chatterjee Road, Kolkata 700035 West Bengal
Kolkata
WEST BENGAL |
09432136040
anjalirrikolkata@gmail.com |
| Dr Sonia Raizada |
Dr. D. P. Rastogi Central Research Institute of Homoeopathy |
A 1/1, Sector 24, Noida – 201301
UTTAR PRADESH
Gautam Buddha Nagar
UTTAR PRADESH |
9717213679
drsoniaraizada@gmail.com |
| Dr A R Sahoo |
Drug Proving Unit |
Dr. A. C. Homoeopathic Medical College & Hospital, Unit-III, Kharavela Nagar, Bhubaneswar- 751001. ORISSA
Khordha
ORISSA |
7008459309
dpu.bbsr@gmail.com |
| Dr Lipipushpa Debata |
Homoeopathic Drug Research Institute |
1 viraj Khand Gomti Nagar Lucknow
Lucknow
UTTAR PRADESH |
7755014040
drlipi08@gmail.com |
| Dr K K Savera |
National Homoeopathy Research Institute in Mental Health |
Sachivothamapuram P.O., Kottayam-686532 KERALA
Kottayam
KERALA |
7012164210
drkksavera@gmail.com |
| Dr B S Rawat |
Regional Research Institute for Homoeopathy |
MTNL Hall No. 4, Shopping Centre, Sector-9, C. B. D. Belapur, Navi Mumbai- 400614. MAHARASHTRA
Thane
MAHARASHTRA |
8080483012
rrimumbaidp@gmail.com |
| Dr BSJ Raja Kumar |
Regional Research Institute for Homoeopathy |
Dr. GGH Medical College Campus, Eluru Road, Gudivada- 521301 ANDHRA PRADESH
Krishna
ANDHRA PRADESH |
9490298989
drbsjrajakumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Central Ethics Committee of CCRH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
No Disease condition |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Drug Code 144 |
To be administered in 6C, 12C, 30C and 200C potencies. 12 doses for each potency, Frequency-Four times a day, Duration of tharapy- 3 days, Routine of administration- Oral |
| Comparator Agent |
Placebo |
Optically identical to the interventional drug substance with same dosage schedule |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Healthy individuals with no apparent disease and normal routine laboratory parameters during screening
2.Healthy individuals identified as fit for proving by experts
3.Intelligent enough to record carefully the facts, subjective and objective symptoms generated by the IPS during proving.
4.Able to be informed of the nature of the study and willing to give written informed consent
|
|
| ExclusionCriteria |
| 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.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.
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.
8.Persons having known history of allergies, food hypersensitivity, etc.
9.Women during pregnancy, puerperium and while breast-feeding and women who have undergone hysterectomy.
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 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 drug code 144 |
At Baseline and after 1 year (completion of the trial) |
|
|
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)
|
10/11/2020 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet published |
|
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. |