Hepatic Medicine: Evidence and Research (Aug 2025)
The Effect of Liv.52 DS in Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD): A Pilot, Randomized, Double-Blind, Placebo-Controlled, Clinical Study
Abstract
Umesh Jalihal,1 Rajesh Amarnath Nanda,2 Kuldeep Katariya,3 Balamurugan Ramanathan,4 Rajesh Kumawat5 1Department of Gastroenterology, Sapthagiri Institute of Medical Sciences & Research Centre, Bangalore, KA, India; 2Department of Medical Gastroenterology, SRM Medical College Hospital and Research Centre, Kattankulathur, TN, India; 3Department of Medicine, Jeevandan Hospital, Bhopal, MP, India; 4Department of Diabetology, Kovai Diabetes Speciality Centre & Hospital, Coimbatore, TN, India; 5Department of Medical Services & Clinical Development, Himalaya Wellness Company, Bengaluru, KA, IndiaCorrespondence: Rajesh Kumawat, Department of Medical Services & Clinical Development; R&D, Himalaya Wellness Company, Makali, Bengaluru, 562162, India, Tel +918067549904, Email [email protected]: Metabolic dysfunction-associated fatty liver disease (MAFLD) is considered a major global health concern. Considering the preliminary trend of hepatoprotective function of Liv.52 DS, the present study was conducted to explore its role in MAFLD.Patients and Methods: This randomized, double-blind, placebo-controlled, prospective, multicenter study was performed at four tertiary care hospitals in India. A total of 52 randomized subjects were administered either Liv.52 DS or placebo tablets twice daily for six months. Liver Stiffness Measurement (LSM) and Controlled Attenuated Parameter (CAP) values were compared at baseline and 6 months. After completion of the study, data from 47 subjects were available for analysis (31 in the Liv.52 DS group and 16 in the placebo group).Results: The mean LSM score, was reduced from 7.3 to 6.0 (Change From Baseline = 17.5%) in the active group with statistically significance (p = 0.007) compared to placebo group with LSM score reduction from 7.5 to 6.9 (CFB = 7.29%). A shift in the mean value from fibrosis (> 6.0 kPa) to almost no significant fibrosis (< 6.0 kPa), as per the Indian National Association for the Study of the Liver (INASL) cutoff, was achieved in the Liv.52 DS Group. Improvement was also observed in CAP values with Liv.52 DS, where 71% of the subjects showed an overall improvement in steatosis grade. The other liver markers like alanine transaminase (ALT) and aspartate aminotransferase (AST) were within the normal range. There were no cases of nephrotoxicity (common concern for herbal formulation), and no drug-related adverse events were reported.Conclusion: A significant improvement in LSM and improvement in CAP was observed after 6 months of treatment with Liv.52 DS using fibroscan. This suggests that Liv.52 DS should be further explored for its potential role in the treatment of unmet medical needs in MAFLD patients.Keywords: metabolic dysfunction-associated fatty liver disease, MAFLD, Liv.52 DS, hepatoprotective polyherbal formulation, hepatic fibrosis, liver stiffness measurement
