Abstract

A CLINICAL COMPARATIVE STUDY TO EVALUATE THE EFFICACY AND SAFETY OF LIV.52 DS TABLETS IN NONALCOHOLIC STEATOHEPATITIS (NASH)

Dr. S.G. Maity and Dr. Asim Kumar Mandal*

Abstract

The present study was planned to evaluate the clinical efficacy andsafety of Liv.52 DS tablets with UDCA in patients with Non-AlcoholicSteatohepatitis in a randomized, comparative clinical study. A total of35 patients aged between 18-65 years with Non-AlcoholicSteatohepatitis characterized by elevated liver enzymes andhepatomegaly with pain and discomfort in the right upper abdomenand those who were willing to give informed consent were included inthe study. At the initial randomization visit, a detailed medical historyand symptomatic evaluation was done. In addition, examinationspecific to the steatohepatitis with Hepatomegaly was also done. Allpatients received liver screen (set of blood tests) including completehaemogram, liver function tests and ultrasound abdomen. All thepatients were routinely screened and subjected to biochemical investigations. Biochemicalinvestigations included SGPT, SGOT, ALT, Serum Bilirubin, Total Protein, Albumin andGlobulin. Clinical examinations were repeated every four weeks for 12 weeks andbiochemical investigations were repeated only after 12 weeks. All the patients wererandomized arbitrarily using random table into either Liv.52 DS group (n=19) or UDCA(n=16). The two groups were similar with regards to the demographic data, baselineparameters and biochemical investigations. The Liv.52 DS group received 2 Tablets twicedaily and UDCA group received 600 mg thrice daily for 12 weeks. Statistical analysis wascarried out using GraphPad Prism Software, Version 4.01. All the patients completed the study and their data was available for analysis. Significant evidence of hepatoprotective effects of Liv.52 DS in patients with Non-Alcoholic Steatohepatitis in terms of clinical response and reduction in biochemical parameters were observed after 12 weeks of treatment. The clinical and biochemical recovery in Liv.52 DS group was faster as compared to UDCA group indicating the beneficial effect of Liv.52 DS tablets in patients with Non-Alcoholic Steatohepatitis. 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 present study showing clinical benefit of Liv.52 DS appear promising in the management of Non-Alcoholic Steatohepatitis.

Keywords: Non-Alcoholic Steatohepatitis (NASH), Liv.52 DS, Ursdeoxycholic acid (UDCA), Non-Alcoholic Fatty Liver Disease (NAFLD).