Efficacy and safety of Huatan Qushi Huoxue Fang granules on obese non-alcoholic fatty liver disease: study protocol for a multicenter, randomized, double-blind, placebo-controlled trial

Abstract

Background The global burden of non-alcoholic fatty liver disease (NAFLD) is parallel to the increasing obesity rates around the world. Phlegm stasis syndrome is a common traditional Chinese medicine syndrome type of obese NAFLD, which is often treated by resolving phlegm, dispelling dampness, and promoting blood circulation. This study mainly explores the clinical efficacy and safety of Huatan Qushi Huoxue Fang (HTQSHXF) granules in the treatment of obese NAFLD. Methods This is a multicenter, randomized, double-blind, placebo-controlled clinical trial that will recruit 248 obese NAFLD patients from three hospitals in China. Randomly allocate patients to either the HTQSHXF group or the placebo group in a 1:1 ratio. The intervention phase lasts for 12 weeks. The primary outcome will be the change in relative liver fat content from baseline to week 12 measured by Magnetic resonance proton density fat fraction (MRI-PDFF). The secondary outcomes will be Body fat percentage (BFR), Waist to hip ratio (WHR), Body Mass Index (BMI), Controlled attenuation parameter (CAP), Liver tiffness value (LSM), serum liver function, blood lipids, blood glucose, Free fatty acids (FFA), Cytokeratin 18-M30 (CK18-M30), and Cytokeratin 18-M65 (CK18-M65). The results will be monitored at baseline and 12 weeks of intervention. Adverse events that occur in this study will be promptly managed and recorded. Discussion This study will use more recognized quantitative methods to explore the efficacy and safety of HTQSHXF granules in treating obese NAFLD, providing clinical evidence for its translational application. Trial registration http://www.chictr.org.cn . Trial number: ChiCTR2200060901. Registered on 14 Jun 2022.