4 | Himalaya Livline | Vol 6 | No. 5 | Sep–Dec 2023 Research at Himalaya Safety and Efficacy of Liv.52® DS in the Management of Nonalcoholic Fatty Liver Disease An excerpt of the study conducted by Siregar G et al published in the European Journal of Clinical and Experimental Medicine has been featured here. Abstract Nonalcoholic fatty liver disease (NAFLD) is characterized by the accumulation of excessive fat in the liver due to factors other than alcohol use. This prospective, interventional clinical study was conducted to evaluate the clinical safety and efficacy of Liv.52 DS tablets in the management of NAFLD. Sixty patients of either sex (aged 18–65 y) who were diagnosed with NAFLD through clinical examination, laboratory tests, and ultrasound findings, and those willing to provide informed consent were included in the study. All patients received 2 Liv.52 DS tablets, BID, for 2 months. Liver function tests, ultrasound to evaluate hepatomegaly, NAFLD fibrosis score, lipid profile, hematology, and biochemical investigations were done at baseline and at the end of months 1 and 2. There was a significant improvement in hepatomegaly and liver function parameters such as aspartate transaminase and alanine transaminase. The NAFLD fibrosis score revealed that there was no progression in liver fibrosis due to NAFLD during the study period. No adverse events were reported during the study. The study demonstrated that Liv.52 DS is safe and effective in the management of NAFLD. Aim To assess the safety and efficacy of Liv.52 DS tablets in the management of nonalcoholic fatty liver disease (NAFLD) Materials and Methods Inclusion criteria This prospective interventional study included 60 patients of either sex (aged 18–65 y) who were diagnosed with NAFLD through clinical examination, laboratory tests, and ultrasound findings, and those who were willing to provide informed consent. Exclusion criteria Alcoholic individuals; patients with severe metabolic disorders, hepatic or pancreatic carcinoma, allergies, systemic diseases, and genetic disorders; and pregnant and lactating women were excluded from the study. Study procedure A detailed medical history of all the patients was obtained, and symptomatic evaluation was performed at the first visit. They were examined for the presence of steatohepatitis with hepatomegaly. All the patients were prescribed 2 Liv.52 DS tablets, BID, for 2 months. Liver function tests (LFTs; including aspartate transaminase [AST], alanine transaminase [ALT], alkaline phosphatase, g-glutamyl transferase, serum bilirubin, and albumin levels), ultrasound findings (for hepatomegaly), and NAFLD fibrosis score (to determine the severity of fibrosis due to NAFLD) were done at baseline and at the end of months 1 and 2. Statistical analysis All data were statistically analyzed using GraphPad Prism software version 6.07 (GraphPad Software, CA, USA). The data obtained from LFTs, biochemical investigations, and NAFLD fibrosis scores were analyzed using ANOVA followed by Tukey’s multiple comparison test. The ultrasound findings of hepatomegaly were analyzed using repeated measures ANOVA followed by Dunnett’s multiple comparison test. NAFLD was graded based on the NAFLD score as < - 1.455 = F0–F2; - 1.455 to 0.675 = indeterminate; and > 0.675 = F3–F4.
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