Clinical Trial of Polyherbal Formulation COVI-RB01 As An Add-On Therapy With Standard of Care In Mild And Moderate Covid-19 Positive Patients
Phase 2
Completed
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2021/10/037378
- Lead Sponsor
- Alakart Bio Pharma Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 130
Inclusion Criteria
RT-PCR based diagnosis of COVID-19
- Treatment trials: cases of mild and moderate severity.
- Willingness to participate.
Exclusion Criteria
- Severe category (Spo2 < 90).
- Individuals with uncontrolled, unstable co-morbidities.
- Individuals with pre-existing respiratory conditions. Immuno-compromised individuals or those on immuno-suppressants.
- Pregnant and lactating females.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Two Point recovery on 10-point WHO Ordinal Scale. <br/ ><br>- Time to Clinical ImprovementTimepoint: During regimen and upto 14 days
- Secondary Outcome Measures
Name Time Method - Time taken to get COVID-19 RT-PCR test negative. <br/ ><br>- Adverse eventsTimepoint: Upto 14 days