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Background: Chyawanprash is a classical Ayurveda polyherbal formulation that has proven immunomodulatory potential. Aim: The present clinical study was conducted to evaluate Chyawanprash for prophylaxis of COVID-19 infection. Materials & Methods: It was an Open-label, Multicentric, Randomized, Comparative, Prospective, and Interventional Community-based Clinical Study. The study was conducted at five sites across Maharashtra, Gujarat, and Rajasthan between May 2020 and November 2020. Materials and Methods: A total of 771 subjects were screened in the study; of whom, 721 subjects were randomized into two groups. Subjects in the DCP group who fell into the category of 13 years to 70 years were given Chyawanprash as a study intervention to be taken in a dose of one teaspoonful (approx. 12g) twice daily and children aged 5 to 12 years were given ½ teaspoonful (approx. 6g) twice daily followed by a cup of milk (approx. 200mL). Subjects in the control group were advised to consume one cup of milk (approx. 200mL) twice daily. The incidence of COVID-19 was assessed by reverse transcription polymerase chain reaction (RT-PCR)/antigen testing, which was conducted as per applicable guidelines and the severity of infection was assessed by using the World Health Organization (WHO) ordinal scale. The incidence and severity of non-COVID-19 infections was also assessed during the intervention period of 90 days. Results: Overall, 696 subjects completed the study, of whom 351 subjects were in the Chyawanprash (DCP) group and 345 were in the control group. In the DCP group, out of the 351 subjects who had completed the study, 42 were tested with RT-PCR/antigen and one subject was found to be positive for COVID-19. In the control group, out of the 345 subjects, 28 were tested with RT-PCR/Antigen and eight subjects were found to be positive for COVD-19. In the DCP group, the incidence was statistically significant lesser as compared with the control group. A total of 43 subjects in the control group and 41 subjects in the DCP group had symptoms of Influenza Like Illness (ILI). The DCP group also showed a statistically significant improvement in quality of life (QoL), as assessed by the Quality of Life Enjoyment and Satisfaction Questionnaire – Short Form (Q-LES-Q-SF) when compared with the control group. Conclusion: The outcome of the present study suggests and supports the prophylaxis potential of Chyawanprash as one of the preventive remedies for COVID-19 as recommended by the AYUSH fraternity. The beneficial effects may be due to the synergistic effects of the potent herbs that are known to have immune-boosting effects in healthy individuals. |
