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CTRI Number  CTRI/2020/05/025205 [Registered on: 15/05/2020] Trial Registered Prospectively
Last Modified On: 20/05/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Cluster Randomized Trial 
Public Title of Study   Arsenicum album – 30 as prophylactic for Covid-19 
Scientific Title of Study   Effectiveness of Arsenicum Album 30c in Prevention of Covid-19 in Individuals Residing in Hot Spots of Red Zones– A Multicentric, Randomised, Cluster Level, 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 Anil Khurana 
Designation  Director General 
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
Scientific Query
 
Name  Dr Debadatta Nayak 
Designation  Research Officer/Scientist-II 
Affiliation  CCRH 
Address  Epidemic Cell 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
Public Query
 
Name  Dr Debadatta Nayak 
Designation  Research Officer/Scientist-II 
Affiliation  CCRH 
Address  Epidemic cell, 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  
 
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 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 11  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Karthikeyan  Hot spots of Covid -19 in Chennai  Homoeopathy Research Institute for Disabilities, 136,NIEPMD Campus East Coast Road, Muttukadu, Chennai 603112
Chennai
TAMIL NADU 
8281488685

drkarthikeyanmd@gmail.com 
Dr Debadatta Nayak  Hot spots of Covid -19 in Delhi  61-65, Sewa Marg, Opp D Block, Institutional Area, Janakpuri, New Delhi, Delhi 110058
South West
DELHI 
09873404012

drdnayak@gmail.com 
Dr Ch Ravender  Hot spots of Covid -19 in Gudivada and Vijaywada  Regional Research Institute for (Homoeopathy) Dr. GGH Medical College Campus, Eluru Road, Gudivada – 521 301 Krishna Dist., Andhra Pradesh State Mob.
Krishna
ANDHRA PRADESH 
9849126380

rrigudivada@gmail.com 
Dr P Hima Bindu  Hot spots of Covid -19 in Hyderabad  Standardisation Unit (Homoeopathy), OUB-32, Street No. 4, Habsiguda, Hyderabad, Tellangana-500007
Hyderabad
TELANGANA 
9490009899

drdewdrop@gmail.com 
Dr Ashish Mahajan  Hot spots of Covid -19 in Jaipur  Central Research Institute (Homoeopathy), Sector 26, Pratap Nagar, Jaipur
Jaipur
RAJASTHAN 
8527266606

dr.aashishmahajan@gmail.com 
Dr P P Pal  Hot spots of Covid -19 in Kolkata  Dr. Anjali Chatterji Regional Research In Homoeopathy 50, Rajendra Chatterjee Road, Kolkata-700035
Kolkata
WEST BENGAL 
8910890779

justdoit.partha@gmail.com 
Dr KC Murleedharan  Hot spots of Covid -19 in Kottayam  National Homoeopathy Research Institute in Mental Health Sachivothamapuram P.O., Kottayam-686 532(Kerala)
Kottayam
KERALA 
9869321223

nhrimh@gmail.com 
Dr Lipipushpa Debata  Hot spots of Covid -19 in Lucknow  Homoeopathic Drug Research Institute National Homoeopathic Medical College & Hospital, 1 Viraj Khand, Gomti Nagar, Lucknow
Lucknow
UTTAR PRADESH 
07755014040

drlipi08@gmail.com 
Dr Ramesh Bawaskar  Hot spots of Covid -19 in Mumbai  Regional Research Institute (Homoeopathy), Hall no. 4, Shopping centre, Sector-9, CBD, Belapur, Navi Mumbai-400614
Mumbai
MAHARASHTRA 
9769888743

drbrsb@gmail.com 
Dr Subhash Kaushik  Hot spots of Covid -19 in Noida  Dr. D. P. Rastogi Central Research Institute of Homoeopathy A-1/1, Sector 24, NOIDA, Gautambudh Nagar, 201301 (U.P.)
Gautam Buddha Nagar
UTTAR PRADESH 
9810788976

subhashccrh@gmail.com 
Dr Vipul R Shatri  Hot spots of Covid -19 in Surat  C.D.Pachchigar Homoeopathic Medical College, Bhatar Road, Nr. Anand Mangal Society, SURAT - 395001
Surat
GUJARAT 
09824109174

drvipulshastri@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee-CCRH  Approved 
Institutional Ethics Committee-CDPCHM  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  For prophylaxis of COVID-19 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Arsenicum album 30C  The Arsenicum album 30C will be given to the high risk contact of COVID 19 cases and residing in hotspots of containment zone. The 4 pills of medicine will be given orally twice daily for 7 days.  
Comparator Agent  No intervention.  The control group clusters will receive no tretment. However the will be under observation similar to medicine group. 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  • High risk contacts of Covid 19 infection who are asymptomatic and residing in hotspots.
• Age 1 year & above
• Both gender
• Willing to give verbal informed consent or written informed consent as the situation may be (keeping in view contagious nature of disease)
 
 
ExclusionCriteria 
Details  • Pregnant women or lactating mothers
• Immunocompromised individuals on basis of medical history.
• Symptomatic (similar to COVID-19) cases at quarantine zone.
• Not willing to give informed consent/verbal consent.
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Centralized 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Confirmation of diagnosis for COVID-19 infection based on RT-PCR / end of quarantine period as per standard protocol.  Every third day till 21st day. 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare the asymptomatic/symptomatic Covid-19 positive cases between the groups.
2. To compare time to appearance of clinical symptoms of COVID-19 infections.
3. To compare time to confirmation of diagnosis for COVID-19 (Laboratory findings)
 
Every third day till 21st day. 
 
Target Sample Size   Total Sample Size="33000"
Sample Size from India="33000" 
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)   24/05/2020 
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="2"
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 prophylactic effect of Arsenicum album 30C 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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