Jalihal Umesh, Nanda Rajesh Amarnath, Katariya Kuldeep, Ramanathan Balamurugan, Kumawat Rajesh
Department of Gastroenterology, Sapthagiri Institute of Medical Sciences & Research Centre, Bangalore, KA, India.
Department of Medical Gastroenterology, SRM Medical College Hospital and Research Centre, Kattankulathur, TN, India.
Hepat Med. 2025 Aug 1;17:61-73. doi: 10.2147/HMER.S527644. eCollection 2025.
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.
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).
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.
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.
代谢功能障碍相关脂肪性肝病（MAFLD）被视为全球主要的健康问题。鉴于Liv.52 DS具有初步的肝脏保护功能趋势，本研究旨在探讨其在MAFLD中的作用。
这项随机、双盲、安慰剂对照、前瞻性、多中心研究在印度的四家三级医疗医院进行。总共52名随机受试者每天服用两次Liv.52 DS或安慰剂片，持续六个月。在基线和6个月时比较肝脏硬度测量（LSM）和受控衰减参数（CAP）值。研究完成后，可以获得47名受试者的数据进行分析（Liv.52 DS组31名，安慰剂组16名）。
与安慰剂组相比，活性组的平均LSM评分从7.3降至6.0（相对于基线的变化=17.5%），具有统计学意义（p=0.007），安慰剂组的LSM评分从7.5降至6.9（相对于基线的变化=7.29%）。根据印度肝脏研究全国协会（INASL）的临界值，Liv.52 DS组实现了从纤维化（>6.0 kPa）到几乎无明显纤维化（<6.0 kPa）的平均值转变。使用Liv.52 DS时，CAP值也有改善，71%的受试者脂肪变性分级总体有所改善。其他肝脏标志物如丙氨酸转氨酶（ALT）和天冬氨酸转氨酶（AST）在正常范围内。没有肾毒性病例（草药制剂常见问题），也没有报告与药物相关的不良事件。
使用FibroScan对Liv.52 DS进行6个月治疗后，观察到LSM有显著改善，CAP也有所改善。这表明应进一步探索Liv.52 DS在治疗MAFLD患者未满足的医疗需求方面的潜在作用。
