An open-label single-arm clinical study to evaluate effectiveness of polyherbal ayurveda formulation in alcoholic liver disease

Abstract

Introduction: According to the WHO, alcoholism is the third leading cause of disease burden. Harmful use of alcohol results in 2.5 million deaths per year. Years of alcohol abuse harm the liver, causing alcohol liver disease. Patoladi Gana Kashaya, a polyherbal Ayurveda formulation, alleviates the adverse effects of alcohol as well as liver disorders caused by it. Aims and Objectives: To study the effectiveness of Patoladi gana kashaya on Madya janya yakrit vikara (alcohol liver disease). Methods: The present study implemented an open-label, single-arm before and after a study conducted at SDM College of Ayurveda Hospital, Hassan with 30 individuals (who fulfilled the inclusion and diagnostic criteria). A convenience sampling method was used for the selection. The trial drug Patoladi Gana Kashaya was given in the dose of 30 ml thrice daily after food with lukewarm water for 30 days. A predefined symptom scale and laboratory investigation were used to measure the efficacy before and after the treatment. Statistical analysis of subjective parameters was assessed using Cochran's Q and McNemar test and objective parameters by t-test. Results: The trial drug showed statistical significance in liver function test and lipid profile. In subjective parameters, statistical significance was obtained in Mandagni, Jwara, Chardi, Udarashoola, Baddhashakrith, and Peetanetrashakruthmootrata (P < 0.05). Conclusion: The polyherbal formulation (Patoladi Gana Kashaya-30 ml t.i.d. after food with 30 ml of warm water) is effective in the management of Madya Janya Yakrit Vikara (alcohol liver disease) and requires further investigations using a more vigorous method.