| CTRI Number |
CTRI/2020/05/025491 [Registered on: 31/05/2020] Trial Registered Prospectively |
| Last Modified On: |
13/07/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
The efficacy of Homeopathic medicines in the prevention of COVID-19 in Quarantined or Exposed Individuals |
|
Scientific Title of Study
|
Double blind, placebo controlled, multi-centric,
cluster randomized study to evaluate the efficacy of Homeopathic medicines in
the prevention of COVID-19 in Quarantined or Exposed Individuals |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajesh Shah |
| Designation |
Principal Investigator |
| Affiliation |
Life Force Foundation Trust |
| Address |
412, krushal commercial complex, 4th floor, above shoppers stop, G.M.Road, Chembur,
Mumbai. 400089
Mumbai
MAHARASHTRA
400089
India |
| Phone |
02266888888 |
| Fax |
|
| Email |
sanjivak@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Shah |
| Designation |
Principal Investigator |
| Affiliation |
Life Force Foundation Trust |
| Address |
412, krushal commercial complex, 4th floor, above shoppers stop, G.M.Road, Chembur,
Mumbai. 400089
Mumbai
MAHARASHTRA
400089
India |
| Phone |
02266888888 |
| Fax |
|
| Email |
sanjivak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh Shah |
| Designation |
Principal Investigator |
| Affiliation |
Life Force Foundation Trust |
| Address |
412, krushal commercial complex, 4th floor, above shoppers stop, G.M.Road, Chembur,
Mumbai. 400089
Mumbai
MAHARASHTRA
400089
India |
| Phone |
02266888888 |
| Fax |
|
| Email |
sanjivak@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Life Force Foundation Trust |
| Address |
412, krushal commercial complex, 4th floor, above shoppers stop, G.M.Road, Chembur,
Mumbai. 400089 |
| Type of Sponsor |
Other [Trust-Research department] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajesh Shah |
Life Force center |
412 Krushal Commercial Complex,
Chembur, Mumbai 400089. India
Mumbai
MAHARASHTRA |
02266888888
sanjivak@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Homeopathy India Private Limited Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1. Arsenic Album 30c potency
2. Bryonia alba 30c potency 3. Camphora 1M potency
4. Coronavirus related nosodes (30c potency)
5. Matching Placebo pills size 30 |
six pills two times a day for 3 days orally |
| Intervention |
Homeopathy medicine |
1. Arsenic Album 30c potency
2. Bryonia alba 30c potency
3. Camphora 1M potency
4. Coronavirus related nosodes (30c potency)
5. Matching Placebo pills |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Quarantined individuals
Covid19 exposure risk groups (For example, police, hospital staff, etc.)
The participant is willing and able to give informed consent for participation in the study
Agrees not to self-medicate with potential antivirals |
|
| ExclusionCriteria |
| Details |
i. Subjects who are detected SARS-CoV-2 positive at baseline ii. Inability to be followed up for the trial period
iii. Subjects who are scheduled to receive any other investigational drug during the study. |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
a. Number of people turning symptomatic
Number of people turning Covid19 positive
c. Number of people recovering after turning positive
d. Number of deaths, if any, if get infection |
Baseline, week 2 and week 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a. The duration of the period of illness for those get infected
b. The severity of the illness of those who get infected. |
Day 0 and Day 30 |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="2233" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
08/06/2020 |
| Date of Study Completion (India) |
27/07/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Under review process. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
In the wake of the COVID19 outbreak, everyone across globe is suffering. Researchers are trying hard to evaluate the remedies to fight against COVID19. Immunity boosting options that provides enhancement of natural defense can be useful. We all know that Prevention is better than cure and currently there is need for prevention of COVID19 illness. Homeopathy medicines are used in past for prevention/ immune boosting measure for influenza illness (other viral and bacterial infection). Ministry of AYUSH has also recommended the use of homeopathic medicines as preventive for the risk groups. The homeopathic medicines used in the formula have been prepared as per the directives of Homeopathy Pharmacopeia of India, under the Ministry of AYUSH, Government of India. The medicines are essentially free form toxic effects. This study plans to evaluate the efficacy of Homeopathic Covid19 Formula in quarantine individuals.
A randomized double-blind, placebo-controlled study was conducted in a quarantine facility. Out of 4,497 quarantined individuals - 2,343 were screened, 2,294 were enrolled and 2,233 completed the trial. Medicines used: Arsenicum album 30c, Bryonia alba 30c, Coronavirus nosode CVN01 30c, Camphora 1M as well as placebo. Bryonia alba 30c and CVN01 30c showed higher efficacy signals compared to placebo. The other medicines did not show any signals as compared to the placebo. The recovery time was shorter in the subjects using Coronavirus nosode CVN01 30c as compared to Bryonia alba 30c, which was mildly significant. |