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CTRI Number  CTRI/2020/06/025844 [Registered on: 12/06/2020] Trial Registered Prospectively
Last Modified On: 11/06/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Pre-Identified Homoeopathic Medicines In Asymptomatic Covid -19 Individuals Receiving Standard Treatment Protocol 
Scientific Title of Study   Comparative Effectiveness Of Pre-Identified Homoeopathic Medicines In Asymptomatic Covid -19 Individuals Receiving Standard Treatment Protocol–An Open Label, Randomised, 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 Varanasi Roja 
Designation  Research Officer (H)/Scientist-2 
Affiliation  Central Council for Research in Homoeopathy 
Address  Clinical Research Room no. 317, Clinical Research Central Council for Research in Homoeopathy 61-65 Institutional Area, Janakpuri

South West
DELHI
110058
India 
Phone  9999454036  
Fax    
Email  varanasiroja@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Varanasi Roja 
Designation  Research Officer (H)/Scientist-2 
Affiliation  Central Council for Research in Homoeopathy 
Address  Room no. 317 Central Council for Research in Homoeopathy 61-65 Institutional Area, Janakpuri

South West
DELHI
110058
India 
Phone  9999454036  
Fax    
Email  varanasiroja@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anil Khurana 
Designation  Director General In Charge 
Affiliation  Central Council for Research in Homoeopathy 
Address  Room no. 408 61-65 Institutional Area, Janakpuri

South West
DELHI
110058
India 
Phone  9911127619  
Fax    
Email  anil23101961@gmail.com  
 
Source of Monetary or Material Support  
Central Council for Research in Homoeopathy, New Delhi 
 
Primary Sponsor  
Name  Central Council for Research in Homoeopathy New Delhi 
Address  61-65, Institutional area, opp D block Janakpuri 
Type of Sponsor  Research institution 
 
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 
Dr Sunita Tomar  Government Homoeopathic Medical College and Hospital  Room no. 2 Medical Superintendent AYUSH Parisar, Kallusot Dam, MACT hills, pin 462003
Bhopal
MADHYA PRADESH 
826875470

dr.sunitatomar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee -CCRH  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  Homoeoapthic medicine   Arsenicum album 30- four pills twice daily for seven days, Bryonia 30- four pills twice daily for seven days, Camphora 1M- four pills twice daily for four days alongwith Standard treatment protocol 
Comparator Agent  Placebo four pills twice daily for seven days  Placebo alongwith Standard treatment protocol 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  COVID 19 confirmed individuals who are Asymptomatic and receiving standard treatment protocol
Age 18 years & above and of both sexes
Willing to sign written informed consent
 
 
ExclusionCriteria 
Details  Pregnant women or lactating mothers
Immunocompromised persons on basis of medical history
Symptomatic COVID-19 individualsNot willing to give informed consent
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
An individual remaining asymptomatic/ becoming symptomatic / virologically negative during the maximum duration of incubation period (21 days)/ till the patient is at CCC as per the standard treatment protocol (ICMR)  At 5th day, 10th day, 15th day 
 
Secondary Outcome  
Outcome  TimePoints 
1. Time to become virologically negative through RT-PCR.
1.Time to appearance of clinical symptoms of COVID-19. 
At 5th day, 10th day, 15th day 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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 2/ Phase 3 
Date of First Enrollment (India)   22/06/2020 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet. 
Brief Summary   Asymptomatic carriers of infectious diseases pose a significant challenge in mitigation efforts, since they display no symptoms but can still be contagious and pass on the disease to other people. For clinical management with symptomatic COVID19 cases there are  array of drugs approved and further trials are ongoing. During this COVID19 outbreak,  a group of experts (SAB, CCRH) discussed the sign and symptoms observed in COVID-19 patients of Wuhan, China from the recent publication of Lancet, “Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China”. Analysis of these symptoms was made to find out the genus epidemicus. Arsenicum album was emerged as Genus epidemicus.This  has also been advised for prevention of ILI.  In Hongkong, Homoeopaths have found Bryonia alba mostly indicated in Covid 19 patients . In another unpublished case series treated by Homoeopath in Iran and other countries prescribed Camphora 1M with encouraging outcomes. This openlabel randomized placebo controlled trial  will be able to estimate the comparative effect of pre identified homoeopathic medicines in asymptomatic covid19 patients receiving standard treatment protocol.
 
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