| Autor: |
Arvind Chopra, Narayanam Srikanth, Bhushan Patwardhan |
| Jazyk: |
angličtina |
| Rok vydání: |
2021 |
| Předmět: |
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| Zdroj: |
Complementary Therapies in Medicine, Vol 62, Iss , Pp 102768- (2021) |
| Druh dokumentu: |
article |
| ISSN: |
0965-2299 |
| DOI: |
10.1016/j.ctim.2021.102768 |
| Popis: |
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. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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