Enhancing protective action of COVID-19 vaccine by using Ashwagandha
- Registration Number
- CTRI/2021/06/034496
- Lead Sponsor
- CCRAS Ministry Of Ayush
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1. Healthy volunteers of either sex aged 18-65 years who have received either the first or second dose of COVID-19 vaccine or have received the booster dose as per the Government policy . Healthy volunteers defined as someone with no known significant health problems
2.SARS-COV-2 RT-PCR negative volunteers
3. Written informed consent by participants
4. The participant willing to comply with study protocol requirements
5. Female participants of childbearing potential must have a negative urine pregnancy test
1.Any known co-morbidity or acute illness with or without symptoms at the discretion of the investigator
2.. History of any known hypersensitivity to any component of study material (Ashwagandha).
3. Any confirmed or suspected condition with impaired/altered function of immune system or possible risk suggested by investigations (e.g. increased levels of D-dimer)
4. Women who are breast-feeding and pregnant
5. Individuals who are using any intervention (AYUSH or other interventions) for prophylaxis or for immune boosting or that may influence immune system e.g. steroids, methotrexate, anti-rheumatoid agents, drugs from AYUSH systems within 30 days prior to screening
6. Individuals who have received systemic immunoglobulins or blood products within 3 months prior to screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method