Safety and effectiveness of selected Siddha formulations and standard of care for COVID-19 – a randomised clinical trial in South India, 2020

Abstract

IntroductionThis study was aimed to determine the effectiveness of selected Siddha formulations and Standard of Care (Treatment group;(n = 76)) compared with only Standard of Care (Control group;(n = 78)) by assessing the accelerated recovery within seven days of treatment. MethodsWe enroled mild and moderate SARS CoV2 patients and selected Siddha formulations as shown in (Supplementary Table 1) and (Supplementary Table 2) were administered for the asymptomatic and Mild COVID cases and for Moderate and Severe COVID cases respectively. The control group was treated with only the standard of care as per India’s Ministry of Health and Family Welfare recommendations. Accelerated recovery was assessed by a 10-point ordinal WHO clinical progression scale. Statistical analysis between the two study groups was calculated using logistic models and expressed as Odds Ratios. ResultsIn the treatment group, 81.6% had accelerated recovery within seven days, which statistically differs from 52.6% in the control group. Multivariate analysis revealed that the accelerated recovery in the treatment group has four (3.8) times higher odds than the control group after adjusting the effect of gender (Adjusted Odds Ratio [AOR] = 3.8; 95% Confidence Interval [CI] = 1.8–7.9). In the treatment group, median time for recovery is 6 days, 95%CI = 5.6–6.4 which is statistically significant from median time of control group 7 days, 95%CI = 6.4–7.6. ConclusionSelected Siddha formulations along with the standard of care showed a significantly higher proportion of accelerated recovery.Clinical Trial Registry of India: CTRI/2020/06/025763.