Efficacy and safety of Jian-Pi Huo-Xue granule for non-alcoholic fatty liver disease: study protocol for a randomized, double-blind, placebo-controlled trial

BACKGROUND: Non-alcoholic fatty liver disease (NAFLD) has become the most prevalent form of chronic liver disease, with a global prevalence of 25% worldwide, but a consensus treatment is still lacking. Previous studies have shown that Jian-Pi Huo-Xue granules (JPHX) can reduce hepatic steatosis in ultrasound images, but lacked quantitative observation in imagined liver fat content. This study aimed to refine the efficacy and safety assessment of JPHX for NAFLD with magnetic resonance imaging-proton density fat fraction (MRI-PDFF) as the primary outcome. METHODS: This is a randomized, double-blind, placebo-controlled clinical trial. The trial will enrol 84 NAFLD participants who will be equally randomized to receive either JPHX or a placebo for 24 weeks. Follow-up will be performed 12 weeks after the intervention. The primary outcome will be the change from baseline to week 24 in MRI-PDFF. Secondary outcomes will be the body weight, body mass index (BMI), waist circumference, waist-to-hip ratio (WHR), serum liver function, blood lipids and glucose-related indicators, quality of life measurement health survey, and traditional Chinese medicine (TCM) syndrome scale. Outcomes will be monitored at baseline, 12 weeks and 24 weeks after enrolment. Adverse events occurring in this trial will be managed and recorded promptly. DISCUSSION: We designed a clinical trial for the treatment of NAFLD using JPHX, a TCM formulation that has been shown to have a positive effect on hepatic steatosis in a previous self-controlled trial. This trial will use a more recognized and quantitative imaging approach to demonstrate the efficacy of JPHX in the treatment of NAFLD and observe its safety to provide clinical evidence for its translational applications. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2100046132. Registered on 4 May 2021.