CTRI/2020/10/028568
Completed
Phase 2
Phase II, open label, randomized controlled trial to evaluate Safety and Efficacy of RV Forte Capsule as an immunomodulator in adult Covid 19 positive patients - NI
RV New Vision Healthcare Pvt Ltd0 sites60 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Sponsor
- RV New Vision Healthcare Pvt Ltd
- Enrollment
- 60
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients admitted with RT\-PCR confirmed COVID\-19 illness
- •Age \> 18 \& \< 65 years of either sex
- •Mild to Moderately Covid 19 disease (NEWS score \<\= 8\)
- •Signed informed consent must be obtained and documented according to AYUSH GCP, and
- •national/local regulations.
Exclusion Criteria
- •Pregnant women
- •Breastfeeding women
- •Requiring ICU admission at screening
- •Patients above 65 years of age and below 18 Years
- •Past History of MI, Epileptic episodes
- •Any other co\-morbidity (uncontrolled diabetes, severe hypertension from subject history) which
- •is at critical stage at screening
- •Any other condition by which subject proves unfit from investigator perspective
- •Not giving consent.
Outcomes
Primary Outcomes
Not specified
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