Abstract: Objective To investigate the efficacy and safety of Ganzaoning granules in the treatment of patients with nonalcoholic fatty liver. Methods 300 patients with nonalcoholic fatty liver were recruited in our hospital between October 2015 and October 2016，and they were randomly divided into two groups，with 150 case in each group. All patients were given a regular diet and exercise therapy，and 150 patients were treated with Ganzaoning granules at the base of diet and exercise therapy. TCM syndrome scores，blood biochemical parameter，clinical efficacy and adverse reactions were observed. Results At the end of 3 month treatment，the total effective rate in the Ganzaoning granule-treated group was 93.3%，significantly higher than 61.3% in the control group （P<0.01）；TCM syndrome score was （9.3±2.1），significantly lower than [（12.8±3.6），P<0.01] in the control group； serum ALT，AST，TC and TG levels were（38.1±12.4） U/L，（36.4±9.6） U/L，（2.1±0.4） mmol/L and（5.2±1.4） mmol/L，significantly lower than [（54.2±9.3） U/L，（50±11.2） U/L，（2.7±0.4） mmol/L and（6.5±1.2） mmol/L in the control，respectively，P<0.01]. Conclusion Ganzaoning granule treatment at the base of diet and exercise therapy in patients with nonalcoholic fatty liver has a good clinical efficacy and safety.

Key words: Non-alcoholic fatty liver disease, Ganzaoning granules, Efficacy