| CTRI Number |
CTRI/2020/04/024857 [Registered on: 25/04/2020] Trial Registered Prospectively |
| Last Modified On: |
25/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Proving the efficacy of Homeopathic treatment in prevention and cure of COVID-19. |
|
Scientific Title of Study
|
Proving the efficacy of Homeopathic treatment in prevention and cure of COVID-19. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSourabh R Welling |
| Designation |
Director |
| Affiliation |
Welling Homeopathy Clinics |
| Address |
Welling Clinic, 2nd Floor, Gokul Arcade, Opp Garware, Sahar Road,Andheri East, Mumbai
Mumbai
Mumbai (Suburban)
MAHARASHTRA
400057
India |
| Phone |
9768068440 |
| Fax |
|
| Email |
drwelling@welling.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSourabh R Welling |
| Designation |
Director |
| Affiliation |
Welling Homeopathy Clinics |
| Address |
Welling Clinic, 2nd Floor, Gokul Arcade, Opp Garware, Sahar Road,Andheri East, Mumbai
Mumbai
MAHARASHTRA
400057
India |
| Phone |
9768068440 |
| Fax |
|
| Email |
drwelling@welling.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DrSourabh R Welling |
| Designation |
Director |
| Affiliation |
Welling Homeopathy Clinics |
| Address |
Welling Clinic, 2nd Floor, Gokul Arcade, Opp Garware, Sahar Road,Andheri East, Mumbai
Mumbai
MAHARASHTRA
400057
India |
| Phone |
9768068440 |
| Fax |
|
| Email |
drwelling@welling.co.in |
|
|
Source of Monetary or Material Support
|
| Welling Healthcare Private Limited |
|
|
Primary Sponsor
|
| Name |
Welling Healthcare Private Limited |
| Address |
2nd Floor, Gokul Arcade, Opp Garware, Sahar Road, Andheri East, Mumbai 400057 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Angelo Smith |
Welling Homeopathy Clinic |
1st Floor, Old Nagardas Road, Andheri East,
Mumbai (Suburban)
MAHARASHTRA |
02226840011
drsmith@welling.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Welling Committee for Ethical Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homeopathy Medicines - Ars Alb, Camphora, Bryonia Alba, Helleborus niger, Justicia Adhatoda. |
Oral Route
In 30c, 1M and 3x potency.
Twice a day till relief from symptoms or tests are negative. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Initial stage of cough and breathlessness and asymptomatic. |
|
| ExclusionCriteria |
| Details |
Patients who have already reached stage where they need ventilator or other life support. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Lesser percentage of admissions to critical care. |
At 4 weeks and 8 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Lesser percentage of mortality |
In 3 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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/ Phase 2 |
|
Date of First Enrollment (India)
|
04/05/2020 |
| 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="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
There are various Homeopathic medicines propounded to be useful in present COVID-19 pandemic. Even AYUSH ministry advised a Homeopathic Medicine ARS ALB as preventive. But according to the Homeopathic community, there are more medicines that can be effective both as preventive and curative. There are already small studies in Iran, France and England, where they have prescribed Homeopathic medicines and found a positive outcome. Here we have a chance to take a lead in showing the efficacy of Homeopathy. Welling Homeopathic Clinics has a presence in Mumbai and Surat with our 9 clinics, stand-alone pharmacy shop & more than 20 full-time Homeopathic consultants to help in a large-scale study if approved. We request early approval to start early to reduce the need for admissions to critical care and reduce the mortality rate. Dr.Sourabh R. Welling,M.D. ( Homeopathy ) |