Evaluate Safety and Efficacy of RV Forte Capsule as an immunomodulator in adult Covid 19 positive patients
Phase 2
Completed
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/10/028568
- Lead Sponsor
- RV New Vision Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method o. of days required for negative PCR confirmatory test <br/ ><br>Change in clinical symptom presentation <br/ ><br>Clinical status expressed in percentage of subjects reporting each severity rating <br/ ><br>Changes in X ray <br/ ><br>Changes in inflammatory mediators like CRP, LDH and ferritinTimepoint: 10 days or negative PCR test for Covid 19 whichever is earlier
- Secondary Outcome Measures
Name Time Method Change in National Early Warning Score <br/ ><br>Hematological parameters like WBS, HB and platelet count etc. <br/ ><br>Requirement of admission to intensive care unit <br/ ><br>Reduced hospital duration <br/ ><br>Total days admitted to the hospital (difference between admission date and discharge date of index admission) <br/ ><br>Timepoint: 10 days or negative PCR test for Covid 19 whichever is earlier