Scientific evaluation of Immuno-modulatory effects of AYUSH INTERVENTIONS on normal healthy and high-risk individuals in context with COVID-19 pandemic: An open level study

Phase 3

• Registration Number: CTRI/2020/06/025861
• Lead Sponsor: Department of Ayush Uttarakhand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Male or female > 18 and < 75 years of age (inclusive).

2. The normal healthy individuals.

3. High risk individuals.

4. Immunosuppressant peoples and subjects with mild to moderate co-morbidities.

5. Non-symptomatic subjects under Institutional and Home Quarantine.

6. Symptomatic subjects under Institutional Quarantine. (Optional, subject to approval from concerned officials and departments)

7. Confirmed COVID-19 cases under isolation and treatment (Optional, subject to approval from concerned officials and departments)

8. Signed ICF

Exclusion Criteria

1. Subjects < 18 and > 75 years of age

2. Uncontrolled systemic illness.

3. Hypersensitivity to any component of Investigational Drug.

4. Recent history of drug or alcohol abuse.

5. Pregnant female.

6. Pre-existing GI symptoms like nausea and vomiting.

7. Patients not willing to sign ICF.

8. Individuals with severe co-morbidities.

Study & Design

• Study Type: Interventional
• Study Design: Not specified