A single-arm pilot study to analyse the hepatic safety of Samshamani Vati / Guduchi Ghana Vati (Tinospora cordifolia (Willd.) Miers) for the Prevention of COVID-19

Background - The distribution of Samshamani Vati / Guduchi Ghana Vati (A preparation of Tinospora cordifolia (Willd.) Miers) to a large population as a prophylaxis medicine for COVID-19 was carried out by the Ministry of AYUSH. This drive was based on the promising clinical outcome in asymptomatic cases of COVID-19 infections. A small report has recently confused the public by showing an association between Guduchi (Tinospora cordifolia (Willd.) Miers) use and the development of herb-induced liver injury (HILI) with autoimmune features in some patients. There is no hepatic safety literature to clear up the confusion. Therefore, in the present pilot study, an attempt was made to create a primary database on the hepatic safety of Samshamani Vati / Guduchi Ghana Vati (Tinospora cordifolia (Willd.) Miers). Objectives- To create a primary database on the hepatic safety of Samshamani Vati / Guduchi Ghana Vati (Tinospora cordifolia (Willd.) Miers). Materials and Methods – Samshamani Vati was administered to subjects selected from the OPD of JSS Ayurveda Medical College, Mysuru, by pre-set inclusion and exclusion criteria, in the dose of four tablets in two divided doses after food with lukewarm water for one month for the assessment of hepatic safety clinically and bio-chemically. Study design – The study design was a single-arm, open-prospective, interventional study. Result- Fifty patients were approached for inclusion in the study. Thirty-one healthy persons fulfilled the criteria, and thirty subjects completed the study. The maximum number of studied participants were females between the age of 20 to 30 years. There is no significant change in liver function test (SGOT, SGPT, Alkaline Phosphatase), complete blood count (Hb% and PLT count) and Serum Creatinine before and after one-month of administration of Samshamani Vati. Conclusion- Samshamani Vati / Guduchi Ghana Vati (TC) has not induced any hepatic dysfunction in terms of clinical symptoms or abnormal liver function tests and is relatively safe.