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CTRI Number  CTRI/2020/05/025069 [Registered on: 07/05/2020] Trial Registered Prospectively
Last Modified On: 16/10/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Trial 
Public Title of Study   Ayurvedic Interventions in prevention of COVID-19 infection-A survey study 
Scientific Title of Study   Impact of Ayurvedic Interventions in prevention of COVID-19 infection in containment areas of Delhi- A community based study  
Secondary IDs if Any  
Secondary ID  Registry 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr BCS Rao 
Address  Central Council for Research in Ayurvedic Sciences 61-65 Institutional Area Oppo. D Block Janakpuri New Delhi

New Delhi
DELHI
110058
India 
Phone  07834877431  
Fax    
Email  bhogavalli8@gmail.com  
 
Details Contact Person
Scientific Query
 
Name  Dr Babita Yadav 
Address  Central Council for Research in Ayurvedic Sciences 61-65 Institutional Area Oppo. D Block Janakpuri New Delhi

New Delhi
DELHI
110058
India 
Phone    
Fax    
Email  drbabitayadav@gmail.com  
 
Details Contact Person
Public Query
 
Name  Dr Babita Yadav 
Address  Central Council for Research in Ayurvedic Sciences 61-65 Institutional Area Oppo. D Block Janakpuri New Delhi

New Delhi
DELHI
110058
India 
Phone    
Fax    
Email  drbabitayadav@gmail.com  
 
Source of Monetary or Material Support  
Central Council For Research in Ayurvedic Sciences, J.L.N.B.C.A.H. Anusandhan Bhawan,no. 61-65, Institutional area, opposite D Block, Janakpuri  
 
Primary Sponsor  
Name  Central Council For Research in Ayurvedic Sciences 
Address  J.L.N.B.C.A.H. Anusandhan Bhawan,no. 61-65, Institutional area, opposite D Block, Janakpuri  
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 = 6  
Contact Person  Name of Site  Site Address  Phone/Fax/Email 
Dr BabitaYadav  Containment zone of COVID 19 at Delhi  Dinpur Village,South West, New Delhi
New Delhi
 
9910171143

drbabitayadav@gmail.com 
Dr BabitaYadav  Containment zone of COVID 19 at Delhi  EA block, Inderpuri, New Delhi
New Delhi
 
9910171143

drbabitayadav@gmail.com 
Dr BabitaYadav  Containment zone of COVID 19 at Delhi  C-785, 3rd Floor, Camp No.2, Nangloi, West Delhi
West
 
9910171143

drbabitayadav@gmail.com 
Dr BabitaYadav  Containment zone of COVID-19 at Delhi  Area around a house in Savitri Nagar, Malviya Nagar, South Delhi
West
 
9910171143

drbabitayadav@gmail.com 
Dr BabitaYadav  Containment zone of COVID-19 at Delhi  Budhnagar, Inderpuri, New Delhi
West
 
9910171143

drbabitayadav@gmail.com 
Dr BabitaYadav  Containment zone of COVID-19 at Delhi  Entire affected street near Gandhi Park, Malviya Nagar, South Delhi
West
 
9910171143

drbabitayadav@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Apparently healthy Population living in containment zone of COVID 19, Delhi  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  Shanshamani Vati or Sudarshana Ghanavati or Ashwagandha  1.Sanshamani Vati 500mg Two times Before meal with water for 1 month 2.Sudarshna Ghanavati 500mg two times before meal with water for 1 month 3. Ashwagandha 500 mg two times before meal with water for 1 month Total duration of therapy is 1 month 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1 Aged 18 to 70 years of both male or female
2 Residents of the identified containment zones, marked by Govt. of
NCT Delhi for high risk of COVID 19
3 Willing to take study medication;
4 Provides written informed consent prior to initiation of study
procedures (or legally authorized representative). Only the copy of
photography of informed consent would be kept for records. 
 
ExclusionCriteria 
Details  1 Persons already treated with any of the study drugs during the last 30 days;
2 Pregnant and lactating females and those who have a pregnancy plan
3 Participants with any immunosuppressive medication or in an immune
compromised state or haematological disease.
4 Laboratory confirmed COVID-19 with or without symptoms.
5 Known allergy to any of the medications used in this trial.
6 Not willing to participate in the study.
7 Any other criteria, as per the investigator would jeopardize the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Incidence of COVID 19 positive cases (as confirmed by hospital by standard investigation (real-time polymerase chain reaction test) among Ayurveda users  3) After enrolment on day one, assessment will be done on day 7, 15, 22 and 30 by telephonic communication or as convenient to the participant. 
 
Secondary Outcome  
Outcome  TimePoints 
1) Incidence of severe COVID 19 positive cases among Ayurveda users
2) Incidence of mortality due to COVID 19 among Ayurveda users.
3) Incidence of any other ailment like cough, fever, sore throat etc during this study
4) Change in appetite, bowel habit, sleep among the users.
5) ADR/AE due to use of any particular Ayurveda advocacies  
After enrolment on day one, assessment will be done on day 7, 15, 22 and 30 by telephonic communication or as convenient to the participant. 
 
Target Sample Size
Modification(s)  
Total Sample Size="9200"
Sample Size from India="9200" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   16/05/2020 
Date of First Enrollment (Global)  No Date Specified 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Brief Summary  

Amid all the gloom spread across the world due to the outbreak of novel coronavirus (COVID-19), which has now infected more than a million people around the world, everyone is focusing on preventive measures. Ayurveda has been an intrinsic part of Indian culture be it kitchen species or usual daily regimen. Further to address the pandemic, Ministry of AYUSH has released certain guidelines for prevention of COVID through certain common kitchen species, herbs and practices.

In order to capture the effectiveness of such preventive measures, guidelines and Ayurveda advocacies, a community study is planned to capture the relative risk and incidence of COVID 19 among Ayurveda users. 

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