ObjectiveTo evaluate the clinical efficacy of modified Zhishi Daozhi decoction in treating patients with metabolic associated fatty liver disease （MAFLD） due to dampness-heat and stasis obstruction. MethodsA randomized controlled trial design was adopted， with patients diagnosed with MAFLD due to dampness-heat and stasis obstruction treated in the Department of Endocrinology， Metabolism， and Gastroenterology at the Third Affiliated Hospital of Changchun University of Chinese Medicine between November 2023 and November 2024 as the study subjects. A total of 126 patients who met the inclusion criteria were randomized into an observation group and a control group， with 63 patients in each group. The observation group was administered the granule preparation of modified Zhishi Daozhi decoction， while the control group received Xuezhikang capsules orally. Both groups underwent a 12-week treatment course. The two groups before and after treatment were compared in terms of obesity indicators ［body weight， body mass index （BMI）， waist circumference （WC）， weight-adjusted waist circumference index （WWI）， and waist-to-hip ratio （WHR）］， lipid indicators ［total cholesterol （TC）， triglycerides （TG）， high-density lipoprotein cholesterol （HDL-C）， and low-density lipoprotein cholesterol （LDL-C）］， liver function indicators ［alanine aminotransferase （ALT）， aspartate aminotransferase （AST）， and gamma-glutamyl transpeptidase （GGT）］， liver ultrasound imaging， traditional Chinese medicine （TCM） symptom scores， and Patient-Reported Outcome （PRO） scale scores at follow-up. Results① After treatment， the body weight， BMI， and levels of TC， TG， and LDL-C declined in both groups （P<0.05， P<0.01）， and the observation group demonstrated larger reductions in BMI， WC， LDL-C （P<0.05）， and WHR （P<0.01）. The levels of ALT， AST， and GGT declined in the observation group after treatment （P<0.05）， whereas no statistically significant differences in the three indicators were observed in the control group before and after treatment. Subgroup analysis based on normal vs. abnormal liver function revealed intergroup differences only in the abnormal liver function cohort. After treatment， the observation group demonstrated greater reductions in ALT （P<0.01） and AST （P<0.05） than the control group. ② The total response rate of liver ultrasound imaging was 79.24% （42/53） in the observation group and 62% （31/50） in the control group. Post-treatment comparison showed that the observation group （χ²=21.311， P<0.01） achieved greater alleviation of fatty liver disease severity. ③ The total response rate of TCM syndrome was 94.34% （50/53） in the observation group and 66% （33/50） in the control group， with the observation group demonstrating superior efficacy （χ²=26.78， P<0.01）. Compared with the control group post-treatment， the observation group showed enhanced reductions in the total TCM symptom score （P<0.01） and individual symptom scores of rib distension and pain， sticky and unsmooth stools， obesity with abdominal distension， sticky sensation in the mouth， and yellowish-red urine （P<0.01）. ④ After treatment， the PRO score improved in both groups （P<0.01）， and the increase was larger in the observation group （P<0.01）， primarily reflected in the physiological dimension （P<0.01）. ConclusionModified Zhishi Daozhi decoction shows definite efficacy in treating MAFLD patients with the syndrome of dampness-heat and stasis obstruction， with effects of alleviating abdominal obesity and regulating blood lipids. Additionally， it positively impacts patients quality of life， as evidenced by the changes in TCM symptom and PRO scores.