A study of Ashwagandha administration in participants vaccinated against COVID-19 on safety, immunogenicity, and protection: A randomized, double blind, placebo controlled, multi-centric clinical trial - AYUSH-AG-VAC-01

CCRAS Ministry Of Ayush0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

试验速览

暂无简介。

•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

发起方

CCRAS Ministry Of Ayush