A Prospective, Controlled, Pilot Study of Personalised Add-on Ayurveda Treatment in High-Risk Type II Diabetes COVID-19 Patients

Introduction: In hospitalised mild to moderate COVID-19 patients with pre-existing type 2 diabetes, we evaluated the efficacy of add-on customised Ayurveda intervention as compared to standard of care (SOC) in ameliorating symptoms, avoiding the need for ICU admission and ventilator support plus bringing down interleukin-6 (IL-6), and C-reactive protein (CRP) over 15 days. Methods: In this quasi-experimental trial, 24 participants per arm diagnosed with COVID-19 by RT-PCR, aged 18-75 years, fulfilling the inclusion/exclusion criteria, were inducted. The subjects were allocated, depending on their own voluntary choice, to SOC plus Ayurveda (group 1) or SOC alone (group 2) for 15 days. The analyses used the Cochran-Mantel-Haenszel test, multivariate ANOVA plus within-group repeated measures ANOVA, and Cochran's Q test. Results: Of the 13 symptoms, cough (P = 0.04), general weakness (P = 0.02), and sore throat (P = 0.02) were statistically significantly different across the groups, with group I (add-on) improving better than group II (SOC). IL-6 dropped rapidly in group 1 by 7 days (P = 0.006) group 2 caught up by day 15 (P = 0.001). CRP improved slower than IL-6. The time to maximum change was not statistically different for IL-6 and CRP between the groups at day 15. There were no differences in random blood sugar and adverse events to Ayurveda-added SOC group. Conclusions: In this quasi-experimental cough, weakness, and sore throat improved more in the add-on Ayurveda than in the SOC. IL-6 concentrations are declining more rapidly in the add-on Ayurveda. Clinical and laboratory adverse events suggested no additional toxicity of add-on Ayurveda treatments. This study supports the need for a randomised, double-blind trial.