AN OPEN CLINICAL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF Liv.52 DS
IN THE MANAGEMENT OF NON-ALCOHOLIC FATTY LIVER DISEASE (NAFLD)
Abstract
Present study was conducted to evaluate the clinical efficacy and safety
of Liv.52 DS tablets in the management of Non-Alcoholic Fatty Liver
Disease (NAFLD) in an open label clinical study. Sixty male and female
patients aged between 18-65 years with NAFLD from clinical examination,
laboratory test, and ultrasound findings and those willing to give
informed consent were included in the study. At the initial visit, a
detailed medical history and symptomatic evaluation was done.
Biochemical investigations included total bilirubin, aspartate and
alanine amino transferase, serum alkaline phosphatase and total
proteins. All the patients received Liv.52 DS at the dose of 2 tablets
twice daily for a period of 2 months. Subjects were evaluated at
baseline, at the end of 1st month, and at the end of 2ndmonth for Liver
function tests, hepatomegaly by ultrasound and NAFLD Score, Lipid
profile and for safety assessment of Hematology and biochemical
investigations. Non-invasive NAFLD fibrosis score was calculated at each
assessment visits to assess the severity of fibrosis due to NAFLD. A
subgroup analysis was done in Diabetes Mellitus Subjects. Statistical
analysis was carried out using GraphPad Prism, Version 4.03 for windows,
Graphpad Software. All the patients completed the study and data was
available for analysis. Significant improvement in hepatomegaly, liver
function parameters (SGPT, SGOT) was observed. A trend towards
improvement in NAFLD score was seen signifying improvement in liver
fibrosis due to NAFLD. Safety laboratory investigation results are
within normal limits and there were no clinically significant adverse
effects were reported during the clinical study. Subgroup analysis
carried out in diabetic subjects further demonstrated beneficial effects
in those populations suffering from NAFLD with respect to hepatomegaly
and LFT levels. From the results of the study, it can be summarised that
Liv.52 DS is safe and beneficial in individuals suffering from NAFLD.