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10.1016/j.ctim.2021.102768

http://scihub22266oqcxt.onion/10.1016/j.ctim.2021.102768
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suck abstract from ncbi


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pmid34418550      Complement+Ther+Med 2021 ; 62 (ä): 102768
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  • Withania somnifera as a safer option to hydroxychloroquine in the chemoprophylaxis of COVID-19: Results of interim analysis #MMPMID34418550
  • Chopra A; Srikanth N; Patwardhan B
  • Complement Ther Med 2021[Nov]; 62 (ä): 102768 PMID34418550show ga
  • 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.
  • |*COVID-19/prevention & control[MESH]
  • |*Withania/adverse effects[MESH]
  • |Adult[MESH]
  • |Female[MESH]
  • |Humans[MESH]
  • |Hydroxychloroquine/adverse effects[MESH]
  • |Male[MESH]
  • |Middle Aged[MESH]
  • |Prospective Studies[MESH]


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