A prophylactic interventional study to determine the possible protective effect of Siddha Polyherbal formulation Kabasura Kudineer against the COVID 19 onintermittent, month-long consumption by public with close contacts to COVID patients and frontline workers in Tamil Nadu, India
Phase 2
Completed
- Registration Number
- CTRI/2020/06/025769
- Lead Sponsor
- ational institute of Siddha Ministry of AYUSH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20462
Inclusion Criteria
All the willing frontline health workers, police personnel and other public servants inclusive of those with direct / primary contacts with COVID positives (High risk and moderate risk exposures).
Exclusion Criteria
Not willing to sign informed consent.
Subjects taking Steroid treatment and or any kind of immunosuppressive therapy
Subjects participating in any other clinical study or having participated in any other study 1 month prior to screening in the present study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of participants protected during the outbreak of COVID 19 compared between the Kabasura Kudineer taken and Standard of Care taken groupsTimepoint: Assessment will be done at Baseline and 30th day from the start of Prophylactic intervention.
- Secondary Outcome Measures
Name Time Method General and specific health status as assessed. <br/ ><br>â?? Immune Status and Function as assessed by ISQ <br/ ><br>â?? Progression of disease in the participants who turned COVID 19 positiveTimepoint: 6 months