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 Study
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.