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CTRI Number  CTRI/2020/05/024986 [Registered on: 04/05/2020] Trial Registered Prospectively
Last Modified On: 03/05/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Trial 
Public Title of Study   HOMOEOPATHY IN PREVENTION OF COVID-19 
Scientific Title of Study   EFFECTIVENESS OF ARSENICUM ALBUM 30C IN PREVENTION OF COVID-19 IN INDIVIDUALS RESIDING IN HOSPOTS OF RED ZONES IN DELHI– A PROSPECTIVE COHORT STUDY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Debadatta Nayak 
Designation  Research Officer/Scientist-II 
Affiliation  CCRH 
Address  Room no 303 61-65, Sewa Marg, Opp D Block, Institutional Area, Janakpuri, New Delhi, Delhi 110058

South West
DELHI
110058
India 
Phone  09873404012  
Fax    
Email  drdnayak@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anil Khurana 
Designation  Director General Incharge 
Affiliation  CCRH 
Address  Room No-408 61-65, Sewa Marg, Opp D Block, Institutional Area, Janakpuri, New Delhi, Delhi 110058

South West
DELHI
110058
India 
Phone  09911127619  
Fax    
Email  anil23101961@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Raj K Manchanda 
Designation  Director AYUSH 
Affiliation  DIRECTORATE OF AYUSH 
Address  Ayurvedic & Unani Tibbia College Campus, Karol Bagh, New Delhi 110005

New Delhi
DELHI
110005
India 
Phone  9811014493  
Fax    
Email  rkmanchanda@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 
Address  61-65, Sewa Marg, Opp D Block, Institutional Area, Janakpuri, New Delhi, Delhi 110058 61-65, Opp D Block, Institutional Area, Janakpuri, New Delhi, Delhi 110058 
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 Debadatta Nayak  Hot spots of Covid -19 in Delhi  Central Council for Research in Homoeopathy 61-65, Opp D Block, Institutional Area, Janakpuri, New Delhi, Delhi 110058
South West
DELHI 
09873404012

drdnayak@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics 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  Homoeopathic Medicine  Homoeopathic medicine Arsenic album 30c will be given to population residing in hot spots of Red zones of Covid-19 out break. The medicine will be given as medicated globules. 2-4 medicated globules will be given twice daily for 7 days. 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  • Suspected cases of Covid 19 infection who
are asymptomatic
• Persons residing in residing in hot spots
of Delhi.
• Age 1 year & above
• Both gender
• Willing to give verbal informed consent (keeping in view
contagious nature of disease)
 
 
ExclusionCriteria 
Details  • Pregnant women
• Lactating mothers
• Immunocompromised individuals on basis of
medical history
• Symptomatic (similar to COVID-19) cases
at quarantine zone.
• Not willing to give verbal informed consent
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Confirmation of diagnosis for COVID-19 infection / end of quarantine period as per standard protocol.  Every 7th day. 
 
Secondary Outcome  
Outcome  TimePoints 
• To compare time to appearance of clinical symptoms of
COVID-19 infections.
• To compare time to confirmation of diagnosis for COVID-19
(Laboratory findings)
 
Every 7th day. 
 
Target Sample Size   Total Sample Size="10000"
Sample Size from India="10000" 
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   N/A 
Date of First Enrollment (India)   13/05/2020 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet. 
Brief Summary  

The results of the study will be able to estimate the protective effect of Arsenicum album in COVID 19 prevention. If found effective, this could prove to be a vital contribution in public health care for a disease with high mortality. Further the cost-effectiveness of homoeopathy will enable developing countries in controlling such deadly disease effectively.  

 
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