To observe the clinical efficacy and safety of Dahuang Zhechong Pills in treating non-alcoholic steatohepatitis(NASH) with a syndrome of intermingled phlegm and blood stasis.Methods:A total of 216 NASH patients with a syndrome of intermingled phlegm and blood stasis admitted to West China Hospital of Sichuan University between May 11，2020，and January 20，2022 were enrolled and randomly divided into a control group and an observation group by block randomization，with 108 patients in each group.After accounting for dropouts(10 in the observation group and 9 in the control group)，the control group received health education and standard treatments including antihypertensives，antidiabetics，lipid regulators，and liver enzyme reducers according to conditions.The observation group received the same treatments with the addition of Dahuang Zhechong Pills.Outcomes were assessed before and after one year of treatment，including liver biopsy resolution rate，liver fibrosis improvement as measured by FibroScan，traditional Chinese medicine(TCM) syndrome scores，body mass index(BMI)，liver function indicators[serum alanine aminotransferase(ALT)，total bilirubin(TB)，serum aspartate aminotransferase(AST)]，lipid indicators[total cholesterol(TC)，high-density lipoprotein cholesterol(HDL-C)，triglycerides(TG)，low-density lipoprotein cholesterol(LDL-C)]，clinical efficacy，and safety.Results:The observation group showed higher liver biopsy resolution rates(χ2=14.512，P=0.002) and liver fibrosis improvement rates(χ2=15.550，P=0.001) than the control group.The total efficacy rate of TCM syndrome relief was also higher in the observation group than in the control group(χ2=21.438，P<0.05).After treatment，both groups showed improvements in BMI，liver function，and lipid profiles(P<0.05)，with no significant differences in BMI and lipid profiles between groups(P>0.05).However，the observation group had lower liver function indicators(ALT，AST，TB) than the control group(P<0.05).A total of 37 mild adverse events occurred，which resolved with or without symptomatic treatment，with no significant difference in adverse event rates between the groups(P>0.05).Conclusion:Dahuang Zhechong Pills can improve liver fibrosis，TCM syndrome，and liver function in NASH patients with intermingled phlegm and blood stasis syndrome，with good safety.