A randomized controlled clinical trial to evaluate the potential of ayurvedic medicines in patients with mild symptoms of COVID-19

OBJECTIVE: The pandemic of COVID‐19 has affected globally and impacted hugely in terms of mortality and morbidity. India is seeing a continuous rise in the number of cases. Ayurveda has suggested many remedies which hold potential to manage COVID 19. The present study is clinical trial to evaluate potential of Ayurvedic formulations such as Chyawanprash Sugar free (SF) and ICB03 in COVID 19 patients along with standard of care as per ICMR. MATERIALS AND METHODS: 90 subjects were enrolled and were grouped into 3 arms as control, Chyawanprash SF and ICB03. Evaluation of serum level of immunological panel CD4, CD8, NK cell panel CD16/CD56 cell counts, inflammatory mediator like CRP, IL‐6, and TNF alpha were carried out along with the assessment of clinical symptoms. The trial duration was of 28 days, the primary assessment was done on screening and on day 21. A telephonic follow up was carried out on day 28 to understand the symptoms and clinical status of the subjects. RESULTS: Treatment with ICB03 and Chyawanprash SF demonstrated that around 50% of subject’s subjects were relieved of cough, shortness of breath and fatigue more effectively and in around 7 days which is short period of time than only standard of care. Subjects with ICB03 and Chyawanprash SF treatment presented improved overall quality of life and early recoveries. There was significant improvement in immunological status of subjects with the treatment of Chyawanprash SF and ICB03. Both Ayurvedic intervention treatment reduced CRP, IL‐6, TNF alpha levels. CONCLUSION: The outcome of this study was reduction in the time to recovery in clinical symptoms, increased CD3, CD4 and natural killer cells and decreased in elevated serum levels of CRP, Il‐6 and tumour necrosis factor alpha (TNF‐α). This study confirms safety of Chyawanprash SF and ICB03 in treatment of COVID 19 with no evident adverse effects as well as excellent tolerability.