CTRI/2020/06/025861
Recruiting
Phase 3
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, multi centric, non-randomized, comparative, interventional community based study
Department of Ayush Uttarakhand0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Department of Ayush Uttarakhand
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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