A randomized controlled trial to evaluate the prophylactic efficacy of Chyawanprash in healthcare workers during the COVID-19 pandemic
Arun Gupta1, Amit Madan2, Babita Yadav3, Pallavi Mundada3, Richa Singhal3, Arunabh Tripathi3, Bhogavalli C Rao3, Bharti Gupta2, Rakesh Rana3, Bhagwan Sharma3, Yogesh Pandey4, Riju Agarwal5, Narayanam Srikanth3, Kartar Singh Dhiman3
1 Department of Panchakarma, Ch. Brahmapraksh Ayurveda Charak Sansthan, Khera Dabar, Najafgarh, New Delhi, India
2 Central Ayurveda Research Institute, CCRAS, Punjabi Bagh, New Delhi, India
3 Central Council for Research in Ayurvedic Sciences, Janakpuri, New Delhi, India
4 Department of Kayachikitsa, Ch. Brahmapraksh Ayurveda Charak Sansthan, Khera Dabar, Najafgarh, New Delhi, India
5 Department of Shalakya Tantra, Ch. Brahmapraksh Ayurveda Charak Sansthan, Khera Dabar, Najafgarh, New Delhi, India
Central Council for Research in Ayurvedic Sciences, Room No. 013, CCRAS Headquarters, 61−65, Institutional Area, ‘D’ Block, Janakpuri 110058, New Delhi.
Source of Support: None, Conflict of Interest: None
INTRODUCTION: Healthcare workers (HCWs) are high-risk individuals in the management of epidemics caused by highly contagious disorders such as coronavirus disease 2019 (COVID-19). Standard of care (SOC) for the prevention of exposure can be greatly supported with SOC measures to improve the immune response. The purpose of this study was to evaluate the effect of combining Chyawanprash, an Ayurvedic formulation, with SOC for prevention versus SOC alone among frontline HCWs through assessment of the proportion of COVID-19 cases among the trial participants during the trial period. METHODS: This open-label, randomized controlled trial was conducted from June 13, 2020 to September 21, 2020 in an Ayurvedic hospital that was functioning as a COVID-19 care center in New Delhi during the pandemic. HCWs between 25 and 60 years of age working in an environment with the possibility of direct exposure to COVID-19 cases were enrolled and observed for 30 days. The interventions compared were SOC as per institutional guidelines and based on their roles (Group I) and SOC in addition to Chyawanprash 12 g twice a day for 30 days (Group II). RESULTS: Out of the 193 participants who completed the study, no participant in both groups was COVID-19 positive at the end of one month. No adverse drug reaction or any serious adverse event was reported during the study. No clinically significant change in the safety parameters were observed. A statistically significant rise in serum IgG level was seen in Group II, but other inflammatory and immune markers did not show any statistically significant difference. In the post-intervention follow-up, four subjects in Group I and two subjects in Group II reported to have developed COVID-19 disease after 2 months of completion of the study period. CONCLUSIONS: Chyawanprash has an immunomodulatory effect in the intervention group, but a longer-term clinical trial with a bigger sample size is needed to confirm its adaptogenic and preventive efficacy as an add-on to standard prophylactic guidelines for prevention of disease. TRIAL REGISTRATION: Clinical Trials Registry of India: CTRI/2020/05/025275 [Registered on: 20/05/2020].