关键词: 非酒精性脂肪性肝病, 临床试验, 中国临床试验注册中心, 特征

Abstract: Objective This study summarized research status of clinical trials related to non-alcoholic fatty liver diseases (NAFLD) registered in Chinese Clinical Trials Registry (ChiCTR). Methods The ChiCTR database was searched for clinical trials related to NAFLD up to July 15, 2023. Excel 2019 software was used to analyze the registration time, region and institution, funding source, research type, design scheme, intervention measures, research stage, randomization or blinding method, research centers, sample size and other feature of the included clinical trials. Results A total of 102 clinical trials related to NAFLD study were included, mainly intervention studies, with a total sample of 144694 cases; the registered areas covered 17 provinces and municipalities directly under the Central government, mainly distributed in Shanghai, Guangdong, Zhejiang and other regions; the study design was mainly randomized parallel controlled studies, while there were 37 studies missing blind method or blanks; intervention measures mainly included medicine and lifestyle, modern diagnosis and treatment technology and combined interventions; the research phase mainly included exploratory research/pre-trial, post-marketing drugs/phase 4 trial and phase I clinical trial; there were 88 single-center studies, while multi-center study seldom if ever. Conclusion The numbers of NAFLD related clinical trial registrations in China is increasing, but lack of high-level, well-designed and multi-center studies.

Key words: Non-alcoholic fatty liver diseases, Clinical trials, Chinese clinical trial registry, Feature