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CTRI Number  CTRI/2020/06/026056 [Registered on: 23/06/2020] Trial Registered Prospectively
Last Modified On: 23/06/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Other 
Public Title of Study   An interventional study to access the effect of Homoeopathic medicine Arsenicum album 30 C as a prohylaxis in high risk population exposed to COVID-19. 
Scientific Title of Study   A prospective interventional study on the effect of Arsenicum album 30 C as a prophylactic measure among High risk population exposed to COVID-19. 
Trial Acronym  ARCOV 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof PK Goswami 
Designation  Director 
Affiliation  North Eastern Institute of Ayurveda and Homoeopathy (NEIAH) 
Address  Office of the Director Department of Samhita and Sanskrit Mawdiangdiang
near police outpost
East Khasi Hills
MEGHALAYA
793018
India 
Phone  9415385128  
Fax    
Email  pkgoswamibhu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Tapan Nath 
Designation  Lecturer 
Affiliation  North Eastern Institute of Ayurveda and Homoeopathy (NEIAH) 
Address  Department of Case Taking and Repertory College of Homoeopathy Room no 24 NEIAH Mawdiangdiang
near police outpost
East Khasi Hills
MEGHALAYA
793018
India 
Phone  8837349308  
Fax    
Email  tapanbngn@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Tapan Nath 
Designation  Lecturer 
Affiliation  North Eastern Institute of Ayurveda and Homoeopathy (NEIAH) 
Address  Department of Case Taking and Repertory College of Homoeopathy Room no 24 NEIAH Mawdiangdiang
near police outpost
East Khasi Hills
MEGHALAYA
793018
India 
Phone  8837349308  
Fax    
Email  tapanbngn@gmail.com  
 
Source of Monetary or Material Support  
Ministry of AYUSH AYUSH BHAWAN B Block GPO Complex INA New Delhi 110023 
 
Primary Sponsor  
Name  Ministry of AYUSH 
Address  AYUSH Bhawan B BLOCK GPO Complex INA New Delhi 110023 
Type of Sponsor  Other [Union Ministry Governmnet of India] 
 
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 
Prof Dr P K Goswami  North Eastern Institute of Ayurveda and Homoeopathy  Office of Director Mawdiangdiang Shillong 793018
East Khasi Hills
MEGHALAYA 		 9415385128

pkgoswamibhu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-NEIAH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  High Risk Population exposed to COVID-19 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Arsenicum album 30 C  Arsenicum album 30 C Once Daily for 3 consecutive days early morning in empty stomach. One adult dose is 5 globules of no. 30 medicated globule One child dose is 3 globules of no. 30 medicated globule 
Comparator Agent  Placebo   Number 30 sugar gloubles will be used as placebo in the control arm 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Subjects of high risk population.
2. Male or female subjects above the age of 03 years to 65 years.
3. Subject who are ready to provide written/digital informed consent and who are willing to participate and follow the protocol requirements of the clinical study. 
 
ExclusionCriteria 
Details  1. Pregnant and Lactating woman.
2. Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening.
3. Subjects who are on any other regular medication( Alternative/ Modern)for any other ailments.
4. Subjects participating in any other clinical study or having participated in any other study one month prior to screening in the present study.
5. Subjects having a past history of allergy to any medicine that is part of the Homoeopathic
intervention. Other conditions, which in the opinion of the investigators, makes the patient
unsuitable for enrolment or could interfere with his participation in, and completion of the protocol. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess of occurrence of COVID-19 infection in healthy volunteers exposed to COVID-19 in the community  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess the immunity status of the participants taking Arsenicum album -30 C
2. To evaluate the occurance of advarse event for safety assessment of Arsenicum album-30C. 		 6 months 
 
Target Sample Size   Total Sample Size="5000"
Sample Size from India="5000" 
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 3 
Date of First Enrollment (India)   26/06/2020 
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="6"
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   This study is a prospective non-randomized interventional trial to assess the effectiveness of Arsenicum album 30 C, 3 or 5 globules (child/adult dose respectively) once daily for three days as a prophylactic measure in 5000 participants of the high-risk population exposed to COVID-19 in one centre in India. The primary outcome will measure the assessment of the occurrence of COVID-19 infection in healthy volunteers and the secondary outcome will assess the immunity status of the participants taking the medicine Arsenicum album 30C. 
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