Study protocol for a randomized, double-blind, double-simulation, positive drug-parallel controlled trial investigating the impact of modified Linggui Yinchen decoction on ApoA1/LCAT activity in the treatment of obese MAFLD

Objective: Metabolic associated fatty liver disease (MAFLD), formerly known as non-alcoholic fatty liver disease (NAFLD), was renamed in 2020 to emphasize its metabolic nature. Presently, modern medicine faces challenges in providing effective treatments for MAFLD. In contrast, traditional Chinese medicine (TCM) has demonstrated potential in alleviating clinical symptoms and improving the liver function. Modified Linggui Yinchen Decoction (M-LGYCD) is derived from Lingguizhugan and Yinchenhao decoctions. This blend is specifically designed to invigorate the spleen, soothe the liver, and alleviate the stagnation of turbid yin. Methods: This study develops a randomized, double-blind, positive drug-controlled trial protocol to investigate the effects of M-LGYCD on apolipoprotein A1 (ApoA1)/lecithin cholesterol acyltransferase (LCAT) activity in reverse cholesterol transport. It is planned to recruit 124 outpatient and inpatient obese MAFLD patients with syndrome of spleen deficiency and liver depression, along with turbid yin stagnation for a period of 8 weeks. The research goal is to assess the efficiency and safety of M-LGYCD by analyzing liver and kidney functions, blood lipids, metabolic indicators, and patient-reported symptoms before and after treatment. Additionally, plasma ApoA1/LCAT activity measurement, transcriptome analysis, and lipid metabolome analysis will be conducted to elucidate the therapeutic mechanism of M-LGYCD and reveal the connotation of spleen deficiency and liver depression, along with turbid yin stagnation syndrome. Discussion: This study is expected to provide a scientific basis and new therapeutic ideas for the TCM treatment of obese MAFLD.