An interventional study to access the effect of Ayurvedic medicine ASA-20 as a prohylaxis in high risk population exposed to COVID-19

Phase 3

Not yet recruiting

• Conditions: High risk population exposed to COVID-19

• Registration Number: CTRI/2020/06/026055
• Lead Sponsor: Ministry of AYUSH

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-06-23
• Study Start: 2020-06-26

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the occurrence of COVID-19 infection in healthy volunteers exposed to COVID-19 in the community	6 MONTHS

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

North Eastern Institute of Ayurveda and Homoeopathy; 🇮🇳 Hills, MEGHALAYA, India

North Eastern Institute of Ayurveda and Homoeopathy

🇮🇳Hills, MEGHALAYA, India

Prof Dr P K Goswami

Principal investigator

9415385128

pkgoswamibhu@gmail.com