An Open-Label Clinical Trial to Evaluate the Safety & Efficacy of Siddha Sastric Medicines – Fixed Regimen in COVID-19 Positive Asymptomatic, Mild or Moderate cases - A Pilot Study

Abstract

Background: Covid-19 is a global pandemic since 2019. SARS-CoV2 is a new virus that originated from China and is currently spread across 160 countries. Siddha medicine is one of the traditional Indian medicines, part of Ayush that tend to treat several acute and chronic diseases. Aim: The objective of this study is to observe the safety and efficacy of Siddha regimen with lab parameters like LFT, RFT, RT-PCR, LDH, FERRITIN levels, and prevention of disease complications in covid-19 positive patients on the 7th day of treatment. Experimental Procedure: A non-randomized open-label observational retrospective study was designed. Twenty patients of either sex, of age between 18 and 60 years, were selected with proper consent. The covid patients who were confirmed by positive RT-PCR test results with or without clinical features of covid-19 were selected. They were treated with Siddha Regimen for seven days. Results: Sixteen out of 20 cases turned RT-PCR negative on their 7th day of treatment. And the Ct value of RT-PCR was statistically significant. LDH and Ferritin levels were reduced after the treatment even though the before treatment values are in the normal range. The LDH level was statistically significant on the 7th day of treatment. No Remarkable changes in the safety laboratory parameters like SGOT, SGPT, Blood urea, Serum Creatinine. Conclusion: Significant changes in efficacy laboratory parameters and no changes in safety laboratory parameters have been reported in the Siddha fixed regimen for covid-positive patients. All the 20 study participants were recovered without emergency and hospitalization.