Randomized, Double Blind, Placebo Controlled, Clinical Trial to Study Ashwagandha Administration in Participants Vaccinated Against COVID-19 on Safety, Immunogenicity, and Protection With COVID-19 Vaccine-A Study Protocol
Chopra A, Chavan-Gautam P, Tillu G, Saluja M, Borse S, Sarmukaddam S, Chaudhuri S, Rao B, Yadav B, Srikanth N, Patwardhan B
Frontiers in medicine · 7 citations
How it was studied
- Design
- Randomized controlled trial (classified by our AI screen)
- Studied in
- People
- Main outcome
- Health markers and function
Who paid for it
- Funding
- Independent funding
- Government
- Ministry of AYUSH, Government of India
- Government
- Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy
Based on 2 listed funder(s) and full-text disclosure statement.
Publication
- Published
- 2022-02-16 · Front Med (Lausanne) · vol. 9 · p. 761655
- Publisher
- Frontiers Media
- Cited
- 10 citations · more than 89% of similar papers · 2.7× the field average
- References
- 28 works
- Access
- Open access (journal) · CC-BY
- Research areas
- Phytochemicals and Medicinal Plants · Diverse Scientific Research Studies · Pharmacology and Nanomedicine Research
- Keywords
- Medicine, Placebo, Vaccination, Interim analysis, Immunogenicity, Adverse effect, Withania somnifera, Randomized controlled trial, Clinical trial, Regimen, Immunology, Internal medicine, Alternative medicine, Immune system
11 authors
From IN
- Arvind Chopra
- Preeti ChavanSavitribai Phule Pune University
- Girish TilluSavitribai Phule Pune University
- Manjit Saluja
- Swapnil BorseSavitribai Phule Pune University
- Sanjeev B. Sarmukaddam
Abstract
Introduction
Vaccines have emerged as the most effective tool in the fight against COVID-19. Governments all over the world have rolled out the COVID-19 vaccine program for their populations. Oxford-AstraZeneca COVID-19 vaccine (COVISHIELD™) is widely used in India. A large number of Indian people have been consuming various traditional medicines in the hope of better protection against COVID-19 infection. Several studies have reported immunological benefits of Withania somnifera (Ashwagandha) and its potential as a vaccine adjuvant. We propose to study the safety, immunogenicity and clinical protection offered by a 6-month regimen of Ashwagandha in participants who volunteer to be vaccinated against COVID-19 (COVISHIELDTM) in the ongoing national program of vaccination.
Methods and analysis
We designed a prospective, randomized, double-blind, parallel-group, placebo-controlled, two-arm, exploratory study on healthy volunteers receiving the COVISHIELDTM vaccine. The administration of Ashwagandha will begin within 7 days of the first or second dose of COVISHIELDTM. Primary outcome measure is immunogenicity as measured by SARS-CoV-2 spike (S1) and RBD-specific IgG antibody titres. Secondary outcome measures are safety, protective immune response and quality of life measures. All adverse events will be monitored at each time throughout the study. Participants will be tracked on a daily basis with a user-friendly mobile phone application. Following power calculation 600 participants will be recruited per arm to demonstrate superiority by a margin of 7% with 80% power. Study duration is 28 weeks with interim analysis at the end of 12 weeks.
Ethics and dissemination
Ethics approval was obtained through the Central and Institutional Ethics Committees. Participant recruitment commenced in December 2021. Results will be presented in conferences and published in preprints followed by peer-reviewed medical journals.
Clinical trial registration
[www.ClinicalTrials.gov], identifier [CTRI/2021/06/034496].
Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY).
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