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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  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 
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 )
 
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