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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, Arvind; Chavan-Gautam, Preeti; Tillu, Girish; Saluja, Manjit; Borse, Swapnil; Sarmukaddam, Sanjeev; Chaudhuri, Susmita; Rao, Bcs; Yadav, Babita; Srikanth, Narayanam; Patwardhan, Bhushan.
  • Chopra A; Center for Rheumatic Diseases, Pune, India.
  • Chavan-Gautam P; Center for Complementary and Integrative Health, Interdisciplinary School of Health Sciences, Savitribai Phule Pune University, Pune, India.
  • Tillu G; Center for Complementary and Integrative Health, Interdisciplinary School of Health Sciences, Savitribai Phule Pune University, Pune, India.
  • Saluja M; Center for Rheumatic Diseases, Pune, India.
  • Borse S; Center for Complementary and Integrative Health, Interdisciplinary School of Health Sciences, Savitribai Phule Pune University, Pune, India.
  • Sarmukaddam S; Center for Rheumatic Diseases, Pune, India.
  • Chaudhuri S; Translational Health Science and Technology Institute (THSTI), Faridabad, India.
  • Rao B; Central Council for Research in Ayurvedic Science, New Delhi, India.
  • Yadav B; Central Council for Research in Ayurvedic Science, New Delhi, India.
  • Srikanth N; Central Council for Research in Ayurvedic Science, New Delhi, India.
  • Patwardhan B; Center for Complementary and Integrative Health, Interdisciplinary School of Health Sciences, Savitribai Phule Pune University, Pune, India.
Front Med (Lausanne) ; 9: 761655, 2022.
Article in English | MEDLINE | ID: covidwho-1731793
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].
Keywords

Full text: Available Collection: International databases Database: MEDLINE Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Language: English Journal: Front Med (Lausanne) Year: 2022 Document Type: Article Affiliation country: Fmed.2022.761655

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Language: English Journal: Front Med (Lausanne) Year: 2022 Document Type: Article Affiliation country: Fmed.2022.761655