| CTRI Number |
CTRI/2018/11/016424 [Registered on: 26/11/2018] Trial Registered Retrospectively |
| Last Modified On: |
31/07/2020 |
| 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 drug proving: Randomized double blind placebo controlled trial for drug code 125 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr RK Manchanda |
| 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
61-65 Institutional Area Opp. D-Block Janakpuri New Delhi-110058
South West
DELHI
110058
India |
| Phone |
|
| Fax |
|
| Email |
rkmanchanda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pritha Mehra |
| Designation |
Scientist-2 |
| Affiliation |
Dr. D.P. Rastogi Central Research institute for Homoeopathy |
| Address |
Dr. D.P. Rastogi Central Research institute for Homoeopathy
A1/1 sector 24, Noida- 201301 (UP)
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
|
| Fax |
|
| Email |
drpritha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pritha Mehra |
| Designation |
Scientist-2 |
| Affiliation |
Dr. D.P. Rastogi Central Research institute for Homoeopathy |
| Address |
Dr. D.P. Rastogi Central Research institute for Homoeopathy
A1/1 sector 24, Noida- 201301 (UP)
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
|
| 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, Opp. D-Block, Janakpuri, New Delhi-110058 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr A R Sahoo |
Drug Proving Unit |
Dr. A.C. Homoeopathic Medical College & Hospital, Unit-III, Kharavela Nagar, Bhubaneswar- 751 001
Khordha
ORISSA |
08763721546
dpu.bbsr@gmail.com |
| Dr J P Singh |
Homoeopathic Drug Research Institute |
1, Viraj Khand, Gomti Nagar, Lucknow-226 010
Lucknow
UTTAR PRADESH |
09415022457
hdri2010@gmail.com |
| Dr B S J Raja Kumar |
Regional Research Institute (H) |
Dr. GGH Medical College Campus, Eluru Road,
Gudivada-521 301
Krishna
ANDHRA PRADESH |
09490298989
rrigudivada@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethics Committee of Central Council for Research in Hommoeopathy |
Approved |
| Institutional Ethics Committee of Central Council for Research in Homoeopathy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
No disease condition |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Drug Code 125 and 126 |
To be administered in 6C, 12C, 30C and 200C potencies. 12 doses for each potency, Frequency- Four times a day, Route of administration- Oral |
|
|
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 125 |
Approximately one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
Final Enrollment numbers achieved (Total)= "46"
Final Enrollment numbers achieved (India)="46" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
27/11/2015 |
| Date of Study Completion (India) |
07/11/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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 proved in ascending potencies. The drug was administered after PME and 1 week run –in –period. The provers are advised to take 4 doses in a day (4 hourly) for 3 days from the prescribed batch of the coded drug. After the completion of the batch, one month washout period will be maintained in all provers, before the next batch is initiated. 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 form the drug pathogenesis. |