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

Abstract Background: Non-alcoholic fatty liver disease (NAFLD) has become the most common chronic liver disease with a prevalence of 25% worldwide, but there is a lack of consensus treatment drugs. Previous studies have shown that Jian-Pi Huo-Xue granule (JPHX) can reduce hepatic steatosis by ultrasound image, but lacks quantitative observation of liver fat content. This study aims to improve the efficacy and safety evaluation of JPHX for NAFLD using magnetic resonance imaging-proton density fat fraction (MRI-PDFF) as the primary outcome. Methods: This is a randomized, double-blind, placebo-controlled clinical trial. This trial will enroll 84 participants with NAFLD, which will be randomized into JPHX or placebo granule groups in equal proportions, and receive JPHX or placebo granules treatment for 24 weeks. A follow-up will be performed 12 weeks after intervention. The primary outcome is the change of MRI-PDFF from baseline to week 24. Secondary outcomes are the body weight, body mass index (BMI), waist circumference, waist-to-hip ratio (WHR), serum hepatic function, serum lipids, blood glucose-related indicators, life quality measuring health surveys, and Traditional Chinese Medicine (TCM) Syndrome Scale. Outcomes will be monitored at baseline, 12 and 24 weeks after enrolment. Adverse events that occurred in this trial will be managed and recorded in time. Discussion: We design a clinical trial for NAFLD management with JPHX, a TCM formula. The results of this trial will present the efficacy and safety of JPHX, and provide clinical evidence for the treatment of NAFLD. Trial registration: Chinese Clinical Trial Registry, ID: ChiCTR2100046132. Registered on May 4, 2021.