An Open-Labelled Randomized Clinical Trial to evaluate the efficacy of Siddha drug - Vettummaaran Kuligai with Nilavembu Kudineer (VMK-NVK) in the Management of Mild to Moderate COVID-19 (SARS-CoV2 infection)

Abstract

COVID-19, caused by SARS-CoV-2, posed an unprecedented global health challenge. There was a growing interest in identifying safe and effective Siddha formulation for the management of COVID-19, and hence the study to evaluate the efficacy of VettummaaranKuligai with NilavembuKudineer (VMK-NVK) in comparison with Ivermectin was explored. COVID-19, caused by SARS-CoV-2, prompted the search for safe and effective Siddha formulations. This open-labelled, randomized case-control clinical trial evaluated the efficacy of Vettummaaran Kuligai with Nilavembu Kudineer (VMK-NVK) compared to Ivermectin in mild to moderate COVID-19 patients. Sixty RT-PCR confirmed cases were randomized into two groups: Group A received VMK-NVK (Nilavembu Kudineer 60 mL with Vettummaaran Kuligai 1 pill twice daily for one week), and Group B received Ivermectin (12 mg/day for 5 days). Clinical assessment was conducted daily, with RT-PCR and laboratory investigations performed weekly. Results showed that VMK-NVK demonstrated non-inferior efficacy to Ivermectin in achieving RT-PCR negativity, with complete viral clearance by day 14 in both groups. Symptom resolution and clinical recovery were comparable. VMK-NVK showed greater reduction in inflammatory markers (IL-6 and CRP), indicating superior anti-inflammatory effects, while both groups had significant reduction in D-dimer levels. No adverse effects were observed, and safety parameters remained normal. In conclusion, VMK-NVK is a safe, affordable, and evidence-based alternative for managing mild to moderate COVID-19, warranting further large-scale, double-blind studies.