A Prospective, controlled, pilot study of personalized add-on Ayurveda treatment in high-risk Type II Diabetes COVID-19 patients

Abstract

Abstract Objective In hospitalized mild to moderate COVID-19 Patients with Type 2 diabetes, we evaluated the efficacy of add-on customized Ayurveda intervention as compared to Standard of Care (SOC) in ameliorating symptoms, ICU admission and Ventilator support plus IL6 and CRP over 15 days. Methods In this quasi-experimental trial, 24 participants per arm diagnosed with COVID-19 by RT-PCR, aged 18 to 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 Group1 by 7 days (p = 0.006) Group 2 caught up by day 15.(p = 0.001). CRP improved more slowly 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 AEs to Ayurveda added SOC group. Conclusion In this exploratory pilot study, cough, weakness and sore throat improved more in the add-on Ayurveda than in the SOC. IL-6 concentrations declining more rapidly in the add-on Ayurveda. Clinical and laboratory AEs suggested no additional toxicity of add-on Ayurveda treatments. This study supports the need for a randomized, double-blind trial.