Evaluation of safety and efficacy of a Polyherbal formulation Liv.52 DS in the Management of Non-Alcoholic Steatohepatitis (NASH): An open clinical study

Non-alcoholic steatohepatitis (NASH) is a clinicopathological entity characterized by histological features resembling alcoholic liver disease that occurs in persons who consume little or no alcohol. NASH is a part of the spectrum of non-alcoholic fatty liver disease (NAFLD) and is defined by of the presence of ballooning (zone 3) hepatocellular injury and inflammation in addition to steatosis. NASH is typically associated with obesity, type II diabetes, dyslipidaemia and the metabolic syndrome. Fifty eligible patients of with NASH were included in the present clinical study. All the subjects were instructed regarding the study procedure and the monthly follow up visits and information regarding the contact person during emergency. All the patients were explained regarding the investigations that will be carried out during the period of the study. The subjects who have qualified the screening and willing to participate in the study were called for the study. They were instructed to take Liv.52 DS tablets 2 tablets twice daily for a period of 3 months. The predefined primary endpoints were improvement in steatohepatitis after the administration of Liv.52 DS Tablets. The efficacy parameters were improvements in clinical as well as liver function tests, ultrasonographic examination and a non-invasive NAFLD score which evaluates the severity of fatty liver fibrosis. The predefined secondary endpoints were incidences of adverse events and overall compliance to the drug therapy. There were no clinically significant adverse reactions; either reported or observed during the entire study period. The overall compliance to the treatment was good and no treatment discontinuations were reported.The results of the studies showed that Liv.52 DS is effective and safe in management of Non-Alcoholic Steatohepatitis. KEYWORDS