Clinical–molecular assessment of Guduchyadi tablet treatment in seven mild COVID-19 patients: a pilot study

Introduction Guduchyadi tablet (GYT), a polyherbal formulation, was evaluated in individuals with mild COVID-19 through a pilot clinical-molecular correlation study. Methods A prospective, parallel-group, two-arm, randomized, open-label pilot study was performed to assess the time to negative COVID-19 reverse transcription polymerase chain reaction (RT-PCR) in patients receiving GYT (n=4) or standard symptomatic care (n=3). Secondary endpoints included time to decline in viral load, time to clinical recovery, COVID-19 antibody titer, COVID-19 complications, patient’s assessment of treatment satisfaction, quality of life (QOL) and adverse drug reactions. Additionally, in vitro evaluation for understanding virucidal activity of GYT was performed. Results Three patients in GYT arm had Omicron XXB.1.16. Time to negative RT-PCR was earlier in patients having GYT, compared to standard care (8.0±1.6 vs. 10.3±2.5 days). The GYT was non-cytotoxic and resulted in ~2 to 3-fold decrease in severe acute respiratory syndrome coronavirus-2 RdRp/N gene expression. Clinical recovery of fever (1.5±1.0 vs. 3.00 days) and cough (4.8±3.9 vs. 6.7±4.7 days) was achieved earlier in GYT group than standard care. The domain scores of QOL were high in GYT arm. No COVID-19 complications, adverse event or requirement of supplemental oxygen/ rescue medication/ hospitalization were noted in both groups. Conclusion Guduchyadi tablet was found to be virucidal and non-cytotoxic, resulting in early clinical recovery and negative RT-PCR. Keywords