Withania somnifera as a safer option to hydroxychloroquine in the chemoprophylaxis of COVID-19: Results of interim analysis
Chopra A, Srikanth N, Patwardhan B, AYUSH CCRAS Research Group
Complementary therapies in medicine · 15 citations
How it was studied
- Design
- Randomized controlled trial (indexed by PubMed)
- Studied in
- People
- Main outcome
- Clinical events such as disease or death
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
- 2021-08-18 · Complement Ther Med · vol. 62 · p. 102768
- Publisher
- Elsevier BV
- Cited
- 28 citations · more than 97% of similar papers · 6.7× the field average
- Impact
- Top 10% most cited in its field
- References
- 8 works
- Access
- Open access (journal) · CC-BY-NC-ND
- Research areas
- Phytochemicals and Medicinal Plants · Andrographolide Research and Applications · Diverse Scientific Research Studies
- Keywords
- Medicine, Withania somnifera, Hydroxychloroquine, Interim analysis, Randomized controlled trial, Chemoprophylaxis, Placebo, Internal medicine, Coronavirus disease 2019 (COVID-19), Alternative medicine, Pathology
- MeSH
- humans, withania, hydroxychloroquine, treatment outcome, prospective studies, adult, middle aged, female, male, covid-19
3 authors
From JP, IN
- Arvind ChopraInstitute for Rheumatic Diseases (Japan)
- Narayanam SrikanthCentral Council for Research in Ayurvedic Science
- Bhushan Patwardhan · correspondingSavitribai Phule Pune University
Abstract
Objectives
To study the efficacy and safety of Withania somnifera (WS, Ashwagandha) in the prophylaxis against COVID-19 in high risk health care workers (HCW) in comparison to hydroxychloroquine (HCQ). To evaluate the general physical and mental health benefits of Ashwagandha.
Methods
A 16 week randomized prospective, open-label, parallel efficacy, two arm, multi-centre study. The primary efficacy measure was 'failure of prophylaxis' as confirmed COVID-19 by quantitative Reverse Transcription Polymerase Chain Reaction (RT-PCR) at any time during the study period. This study on 400 participants from three centres was designed to establish non-inferiority for WS to HCQ for prophylaxis against COVID-19 at 80 % power and significance p < 0.025, one-sided. The interim analysis was carried out on 160 participants after completion of 8 weeks.
Results
Participants in both the arms were well-matched at the baseline characteristics. Forty participants in the HCQ group and 26 participants in the WS group reported mild AE. The symptoms of confirmed COVID-19 were found to be 3.7 % (95 % CI 1.3-10.5 %) in the HCQ and 1.3 % (95 % CI 0.02-6.7 %) in the WS arm amongst the first 160 participants completing 8 weeks.
Conclusion
Our intent was to explore a safer option to HCQ. We report that WS was not found inferior to HCQ and its efficacy was within the 15 % non-inferiority margin set a priori. WS as an immunomodulator has other clinical benefits including reducing mental stress. The final report of this study is expected by end of August 2021.
Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY-NC-ND).
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