Safety and efficacy of Siddha management as adjuvant care for COVID-19 patients admitted in a tertiary care hospital - An open-label, proof-of-concept Randomized Controlled Trial

Background: COVID-19 resulted in loss of human lives owing to respiratory failure caused by dysregulated immune system. Though many treatments are evaluated, the most appropriate is yet to be established. Objective: To determine the safety and efficacy of Siddha add-on therapy in COVID -19 in terms of accelerated recovery, reduced hospital stay & mortality and follow up assessment of post discharge status until 90 days as compared to the Standard Care management. Methods: In a randomized, controlled, single-center, open-label trial conducted on 200 hospitalized COVID-19 patients, they were allocated equally to be treated with add-on Siddha regimen with Standard care or only Standard care. Standard care was in accordance to the Government norms. Recovery was defined as amelioration of symptoms, viral clearance and attaining SpO2 > 94% in room air indicating the derived score of zero on WHO clinical progression scale. The primary and secondary end points were accelerated recovery (≤ 7 days) and mortality comparison between the groups respectively. Also, disease duration, length of hospital stays and laboratory parameters were assessed for safety and efficacy. Patients were followed through for 90 days after admission. Results: In this study the accelerated recovery was 59.0% and 27.0% in treatment and control groups (ITT analyses) (p < 0.001) respectively and Odds for it were four times higher in the treatment group (OR: 3.9; 95% CI: 1.9, 8.0). The estimated median time for recovery in the treatment group was 7 days (95% CI: 6.0, 8.0; p=0.003) and 10 days (95% CI: 8.7, 11.3) in control. Hazard ratio for death in control was 2.3 times that of treatment group. No adverse reactions or alarming laboratory values were observed in response to intervention. In Severe COVID treatment group (n=80), mortality was 15.0% and 39.5% in control (n=81). The COVID stage progression was 65% less in test group. Mortality during treatment and 90 days follow up in Severe COVID patients were 12 (15%) and 35 (43.2%) in treatment and control groups respectively. Conclusion: The selected Siddha regimen when co-administered with Standard of Care have demonstrated that they can synergistically act to improve oxygenation status of patients, enhance the recovery rate from COVID-19 and reduce the mortality better when compared to administration of only Standard of Care. Clinical Trial Registry of India: CTRI/2020/06/025768 Registered on: 09/06/2020.