Objective To evaluate the effect and safety of Dangfei Liganning Capsule [ Capsule of Dangyao （Swertia sinensis） and Shuifeiji （Silybum marianum） for the liver diseases ] in the treatment of nonalcoholic simple fatty liver disease with the damp-heat retention syndrome in TCM.Methods A multicentric

randomized

double-blind

placebo parallel controlled trial was conducted in the treatment of nonalcoholic simple fatty liver disease.Totally 230patients accorded with the standards of diagnosis of nonalcoholic simple fatty liver disease and damp-heat retention syndrome in TCM were in cluded

of which

227were of full analysis set （FAS）

and were randomized into Dangfei Liganning Capsule group （trial

113cases） and placebo group （control

114cases）.The course of treatment was of 12weeks.The effect was evaluated with the changes in the liver/spleen CT ratio

liver/spleen CT recovery ratio

and improvement of TCM symptoms

while the safety was assessed with the adverse events

laboratory examination

and changes in ECG.Results After treatment

the liver/ spleen CT ratio of both groups was significantly different from that before treatment （P<0.01）

and the difference between the two groups was statistically significant （P<0.01）.In the trial group

the liver/ spleen CT recovery rate was 47.79% （54/ 113cases）

while that of controlled group was 22.81% （26/ 114cases）.The difference between groups was statistically significant （P<0.01）.The total effective rate of the trial group and the control group was 76.11%and 55.26%respectively

the difference was significant （P<0.01）.The epigastric distention and fullness and dry mouth and bitter taste of both groups after treatment were significantly alleviated

being significantly different from those of before treatment （P<0.01）.The difference in the between-group comparison after treatment was statistically significant （P<0.01）

the trial group was superior to the control group.The ALT decrease of the trial group after treatment was statistically significant （P<0.01）

the ALT decrease of the control group was not statistically significant （P>0.05）

and the difference between groups was not statistically significant （P>0.05）.Conclusion Dangfei Liganning Capsule is effective and safe in the treatment of nonalcoholic simple fatty liver disease with the damp-heat retention syndrome in TCM.