CTRI Number	CTRI/2020/06/026055 [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	Ayurveda
Study Design	Other
Public Title of Study	An interventional study to access the effect of Ayurvedic medicine ASA-20 as a prohylaxis in high risk population exposed to COVID-19
Scientific Title of Study Modification(s)	A prospective interventional study on the effect of ASA-20(Ayush kwath, Samsamani vati, Anu taila) as a prophylaxis measure among High risk population exposed to COVID-19
Secondary IDs if Any	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)	Name  Prof Dr P K Goswami  Address  Office of the Director Administrative Block North Eastern Institute of Ayurveda and Homoeopathy Mawdiangdiang Shillong East Khasi Hills MEGHALAYA 793018 India  Phone  9415385128   Fax     Email  pkgoswamibhu@gmail.com
Details Contact Person Scientific Query Modification(s)	Name  Dr Sikha Lekharu  Address  Department of Samhita Siddhnat Room no 18 College of Ayurveda North Eastern institute of Ayurveda and Homoeopathy Mawdiangdiang Shillong East Khasi Hills MEGHALAYA 793018 India  Phone  8811834122   Fax     Email  shikhalekharu@gmail.com
Details Contact Person Public Query Modification(s)	Name  Dr Sikha Lekharu  Address  department of Samhita Siddhant room no 18 College of Ayurveda North Eastern Institute of Ayurveda and Homoeopathy Mawdiangdiang Shillong East Khasi Hills MEGHALAYA 793018 India  Phone  8811834122   Fax     Email  shikhalekharu@gmail.com
Source of Monetary or Material Support	Ministry of AYUSH
Primary Sponsor	Name  Ministry of AYUSH  Address  AYUSH Bhawan B BLOCK GPO Complex INA New Delhi 110023  Type of Sponsor  Other [Union Ministry Government of India]
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study Modification(s)	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Prof Dr P K Goswami  North Eastern Institute of Ayurveda and Homoeopathy  Office of the Director Mawdiangdiang Shillong 793018 East Khasi Hills   9415385128 pkgoswamibhu@gmail.com
Details of Ethics Committee Modification(s)	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 Modification(s)	Type  Name  Details  Intervention  ASA-20  Ayush kwath- 3gm twice daily after food Samsamani Vati- 500 mg twice daily after food Anu taila- 2 drops twice daily in each nostril The total duration of Ayurveda intervention will be for 30 days.   Comparator Agent  Non-treatment Control   In the non-treatment control group no medicine/placebo will be administered. Standard guidelines for COVID-19 prevention will be followed.
Inclusion Criteria Modification(s)	Age From  15.00 Year(s) Age To  70.00 Year(s) Gender  Both  Details  1 Subjects of high risk population 2 Male or female subjects above the age of 15 years to 70 years. 3 Subjects 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 regular medication(alternative/modern) for any other ailments. 4 Subjects participating in any other clinical study or having participated in any other study 1 month prior to screening in the present study. 5 Subjects having a past history of allergy to any medicine that is part of the Ayurvedic intervention. Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrollment 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 Modification(s)	Outcome  TimePoints  To assess the occurrence of COVID-19 infection in healthy volunteers exposed to COVID-19 in the community  6 MONTHS
Secondary Outcome Modification(s)	Outcome  TimePoints  1 To assess the immunity status of the participants taking ASA-20. 2 To evaluate the occurrence of adverse event for safety assessment of ASA-20.   6 MONTHS
Target Sample Size Modification(s)	Total Sample Size="5000" Sample Size from India="5000"
Phase of Trial	Phase 3
Date of First Enrollment (India) Modification(s)	26/06/2020
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="0" Months="6" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Not Yet Recruiting
Publication Details	not yet
Brief Summary Modification(s)	This study is a prospective non- randomised interventional trial to access the effectiveness of ASA-20 ( Ayush kwath- 3gm twice daily after food, Samsamani vati- 500mg twice daily after food, Anu taila- 2 drops in each nostril twice daily for 30 days) as a prophylactic measure in 5000 participants of high risk population exposed to COVID-19 in one centre in India. The primary outcome will be to assess the occurrence of COVID-19 infection in healthy volunteers. The secondary outcome will assess immunity status of the participants taking ASA-20.