AYUSH medicine as add-on therapy for mild category COVID-19; an open label randomised, controlled clinical trial

Abstract Background AYUSH formulations have a potential role in symptomatic treatment, preventing disease progression and improving quality of life in COVID-19 patients. Objective To study the effect of AYUSH formulation (Kabasura Kudineer tablets, Shakti drops and Turmeric plus) as an add-on treatment in patients with mild COVID - 19 Methodology Single centre, two arms, open labelled randomized controlled trial with a total of 30 patients (15 in the intervention arm and 15 in the standard care arm). Intervention arm received a combination of 3 AYUSH formulation along with the standard of care treatment for 21 days. All patients were followed for 28 days. Symptom severity (using Modified Jackson scale), negative conversion of SARS-CoV-2 RNA (using RTPCR) and quality of life (WHOWOL BREF questionnaire) was assessed. Results Fifteen patients (93.8%) in the intervention group and twelve patients (92.3%) in the standard care arm had complete resolution of symptoms (P value= 0.36). Negative conversion for SARS-CoV-2 was seen in thirteen patients (92.9%) in intervention arm and eleven patients (100%) in standard care arm at day 28 (P value = 0.56). There was no difference in the quality of life scores between the 2 groups. Conclusion The use of Ayush interventions as add-on therapy did not negatively impact the clinical outcomes in COVID-19. This trial confirmed the safety and tolerability of Kabasura Kudineer tablets, Shakti drops and Turmeric plus tablets when used use among mild to moderate symptom category, of COVID-19. There were no serious adverse events in the treated group. There was no clinical progression of disease from baseline status and all trial participants recovered fully by day 28. A longer follow up and a larger sample size is recommended for future definitive trials with this alternative medicine (AYUSH) combination.