28 • Probe •Vol LXII • No. 3 • May–Aug 2023 Effect of Liv.52® DS on Various Liver Parameters in Nonalcoholic Fatty Liver Disease: A Cumulative Analysis Sharad C Shah1, Prasanna S Shah2, Nusly PJ Pocha3, Gontar Siregar4, Srikrishna HA5, Rajesh Kumawat6* Int J Pharm Clin Res. 2022;14(6):739–751. Authors’ Affiliations 1Department of Gastroenterology, JJ Group of Hospitals, Mumbai, Maharashtra, India 2Department of Gastroenterology, Breach Candy, Jaslok, and Saifee Hospitals, Mumbai, Maharashtra, India 3Medical Consultant to Air France, KLM, and Lufthansa German Airlines, India 4Department of Internal Medicine, University of Sumatera Utara, Medan, Sumatera Utara, Indonesia 5Research and Development Center, Himalaya Wellness Company, Bengaluru, Karnataka, India 6Medical Services and Clinical Development, Research and Development Center, Himalaya Wellness Company, Bengaluru, Karnataka, India Aim To evaluate the effect of Liv.52 DS tablets on various liver parameters in nonalcoholic fatty liver disease (NAFLD) Materials and Methods Four clinical studies comprising 155 patients (aged 18–75 y; both sexes) who received 2 Liv.52 DS tablets, BID, orally, were considered for the cumulative efficacy analysis. Of the 4 studies, 2 were comparative, controlled clinical studies performed for 3 months (Liv.52 DS vs ursodeoxycholic acid and Liv.52 DS vs placebo), and the other 2 studies were single-arm clinical studies performed for 2 and 3 months, with Liv.52 DS alone. Clinical data specifically related to the Liv.52 DS arm of the studies were considered for the cumulative analysis. The studies’ outcomes were evaluated based on the improvement in the following parameters: NAFLD clinical signs and symptoms, hepatomegaly assessed using ultrasonography, serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) levels, NAFLD fibrosis scores, aspartate aminotransferase to platelet ratio index, and fibrosis-4 score. Data were presented as mean ± standard deviation for quantitative variables, and as proportions and percentages for categorical variables. Comparisons of continuous variables within groups were performed using the paired t test. Comparisons of different categorical variables were performed using the χ2 or Fisher’s exact test. Results The cumulative analysis showed a significant reduction in SGPT (P < .0001) and SGOT (P < .0001) levels at the end of the study in 153 patients, compared with the baseline values (Tables 1 and 2). The ultrasonography results revealed a significantly improving trend in fatty liver grades at the end of the study in 90 patients. At the end of the study, 38% of the patients had grade 0, 60% had grade 1, 2% had grade 2, and no patients were reported with grade 3 fatty liver. The percentage of patients with *Correspondence Dr Rajesh Kumawat Head, Medical Services and Clinical Development Research and Development Center Himalaya Wellness Company Bengaluru 562162, Karnataka India E-mail: rajesh.kumawat@himalayawellness.com
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