A polyherbal formulation for non-alcoholic fatty liver disease: a phase 1 clinical trial

Abstract

BACKGROUND: The global prevalence of non-alcoholic fatty liver disease (NAFLD) is estimated to be 24%. The management of NAFLD consists of treatment of any underlying metabolic disease and lifestyle modifications. Thus, exploring new medicines is important to reduce morbidity, mortality, and related healthcare costs. Link-Livecare (LLC) is a proprietary Ayurveda polyherbal tablet comprising 14 herbs indicated for liver diseases. LLC had been tested for acute, subacute, and sub-chronic toxicity and hepatoprotective efficacy in animal studies prior to the conduct of this study. The objective was to assess the safety of LLC in humans as a prerequisite for efficacy studies using randomized and double-blinded clinical trials. METHODS: An investigator-led open-label phase 1 study was conducted on 28 healthy volunteers who received an oral daily dose of 900 mg of LLC for 90 days. Anthropometric, clinical, haematological, liver, and renal parameters were assessed at baseline and monthly intervals for 120 days. Adverse events and drug compliance were also assessed during the study. The data analysis followed the intention-to-treat principle. RESULTS: 21 volunteers completed the 4-month study. The mean age was 28 ± 6 years, and 85.7% were males. The clinical and biochemical parameters remained within the respective normal ranges. There were no significant adverse events, and none discontinued the study due to adverse events. The mean drug compliance was 88.9%. Conclusions: LLC is safe and well tolerated by healthy volunteers. It is recommended to conduct Phase 2 trials in NAFLD patients either alone or in combination with other treatment modalities to study in detail the adverse events, if any, and better describe the pharmacodynamic properties. TRIAL REGISTRATION: The study was approved by the SIDCER-FERCAP-accredited Ethics Review Committee, Faculty of Medicine, University of Colombo, Sri Lanka (EC/21/048) and was registered in the Sri Lanka Clinical Trials Registry, a member of the primary registry of the World Health Organization (International Clinical Trial Registration Platform: SLCTR/2021/030). (Niriella et al., 2025)