Efficacy of AYUSH 64 as add-on therapy in early stage COVID 19 - An open-label randomized controlled pilot study

Abstract

Background: Efficacy of AYUSH 64 has been proven in fever and influenza-like illness earlier. Hence it was felt it should be evaluated in COVID 19 which has similar symptom complex. Aim: To evaluate the clinical efficacy of AYUSH 64 as an add-on to standard care in early stage COVID-19 patients. Materials and methods: After obtaining IEC permission, a single centre, randomized, open labelled, controlled, pilot study was undertaken. Asymptomatic to mild COVID 19 (RT-PCR positive) patients, who gave written informed consent, were randomly allotted either AYUSH 64 for 14 days as an add-on treatment to standard care or standalone standard care. The outcomes variables were changes in WHO ordinal scale for clinical improvement, incidence of development of COVID symptoms, use of oxygen therapy, use of mechanical ventilator, duration of total symptomatic phase, adverse drug reaction, death and changes in laboratory values. Results: Among total 115 screened, 80 participants were included, out of which 41 received AYUSH 64 in addition to standard care and 39 only standard care. The mean final WHO score was comparable for both the Groups, however, mean scores in the interventional Group showed downward trend from 7th day onwards as compared to the control Group. Difference in laboratory values and need for oxygen were not statistically significant in both the Groups. No incidence of the requirement of a mechanical ventilator, adverse drug reaction, and death were observed in either of the Groups. Conclusion: The findings of this study show that an integrated approach of AYUSH 64 with standard care did not exert promising difference in core outcomes of COVID-19 when compare to standalone standard care. However, a trend towards lower values was observed in the symptoms in AYUSH 64 add-on group in comparison to standalone standard care.