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Complementary Therapies in Medicine 2022 June ; 66 :102814 [Epub ahead of Print]
AYUSH-64 as an adjunct to standard care in mild to moderate COVID-19: An open-label randomized controlled trial in Chandigarh, India
Harbans Singh (1), Sumit Srivastava (2), Babita Yadav (3), Amit K Rai (4), Sophia Jameela (5), Sanuj Muralidharan (6), Rijin Mohan (7), Shikha Chaudhary (8), Richa Singhal (9), Rakesh Rana (10), Shruti Khanduri (11), Bhagwan S Sharma (12), Bhogavalli Chandrasekhararao (13), Narayanam Srikanth (14), Sarika Chaturvedi (15)
1. Department of Ayurveda, Central Ayurveda Research Institute, Patiala, Punjab, India. Electronic address: dr.harbans@rediffmail.com. 2. Department of Ayurveda, Shri Dhanwantry Ayurvedic College and Hospital, Chandigarh, India. Electronic address: sumitpankaj@gmail.com. 3. Department of Ayurveda, Central Council for Research in Ayurvedic Sciences, Ministry of Ayush, Govt. of India, India. Electronic address: drbabitayadav@gmail.com 4. Department of Ayurveda, Central Council for Research in Ayurvedic Sciences, Ministry of Ayush, Govt. of India, India. Electronic address: amit.rai@ccras.nic.in. 5. Department of Ayurveda, Central Council for Research in Ayurvedic Sciences, Ministry of Ayush, Govt. of India, India. Electronic address: drsophia9754@gmail.com. 6. Department of Ayurveda, Shri Dhanwantry Ayurvedic College and Hospital, Chandigarh, India. Electronic address: drsanujmuralidharan@gmail.com. 7. Department of Ayurveda, Shri Dhanwantry Ayurvedic College and Hospital, Chandigarh, India. Electronic address: drrijinm@gmail.com. 8. Department of Ayurveda, Shri Dhanwantry Ayurvedic College and Hospital, Chandigarh, India. Electronic address: drshikha08@icloud.com. 9. Biostatistical Unit, Central Council for Research in Ayurvedic Sciences, Ministry of Ayush, Govt. of India, India. Electronic address: richa.singhal2k@gmail.com. 10. Biostatistical Unit, Central Council for Research in Ayurvedic Sciences, Ministry of Ayush, Govt. of India, India. Electronic address: rkrana2000@gmail.com 11. Department of Ayurveda, Central Council for Research in Ayurvedic Sciences, Ministry of Ayush, Govt. of India, India. Electronic address: drshruticcras@gmail.com. 12. Department of Ayurveda, Central Council for Research in Ayurvedic Sciences, Ministry of Ayush, Govt. of India, India. Electronic address: bssccras@gmail.com 13. Department of Ayurveda, Central Council for Research in Ayurvedic Sciences, Ministry of Ayush, Govt. of India, India. Electronic address: bhogavalli49@gmail.com 14. Department of Ayurveda, Central Council for Research in Ayurvedic Sciences, Ministry of Ayush, Govt. of India, India. Electronic address: srikanthccras@gmail.com. 15. Department of Research Directorate, Dr. D Y Patil Vidyapeeth, Pune, Maharashtra, India. Electronic address: sarikabharat2005@gmail.com.
Abstract
Objective: To determine the therapeutic efficacy and safety of AYUSH-64 as an add-on to standard care in mild to moderate COVID-19. Design setting, and interventions: This open-label randomized controlled parallel-group trial was conducted at a designated COVID care centre in India in 80 patients diagnosed with mild to moderate COVID-19 and randomized into two groups. Participants in the AYUSH-64 add-on group (AG) received AYUSH-64 two tablets (500 mg each) three times a day for 30 days along with standard conventional care. The control group (CG) received standard care alone. Main outcome measures: Proportion of participants who attained clinical recovery on day 7, 15, 23 and 30, proportion of participants with negative RT-PCR assay for COVID-19 at each weekly time point, change in pro-inflammatory markers, metabolic functions, HRCT chest (CO-RADS category) and incidence of Adverse Drug Reaction (ADR)/Adverse Event (AE). Results: Out of 80 participants, 74 (37 in each group) contributed to the final analysis. Significant difference was observed in clinical recovery in the AG (p < 0.001 ) compared to CG. Mean duration for clinical recovery in AG (5.8 ± 2.67 days) was significantly less compared to CG (10.0 ± 4.06 days). Significant improvement in HRCT chest was observed in AG (p = 0.031) unlike in CG (p = 0.210). No ADR/SAE was observed or reported in AG. Conclusions: AYUSH-64 as adjunct to standard care is safe and effective in hastening clinical recovery in mild to moderate COVID-19. The efficacy may be further validated by larger multi-center double-blind trials. Keywords: Ayurveda; COVID-19; Integrative medicine; Pandemic; Viral disease.
DHARA ID: D059260 Pubmed ID: 35149205
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