Objective To survey and assess the therapeutic effectiveness and safety rate of keganzhi capsules(KGZC) in the treatment of fatty liver. Methods 48 qualified patients with fatty liver were randomly divided into 2 equal groups,the trial group and control group.Patients of the trial group and control group were given each 5 KGZCs and 3 tablets of Dongbaogantai(DBGT) PO,t.i.d.,respectively.The course of treatment in both groups lasted 3 months.A 3-month follow-up study was carried out after the termination of the treatment.Before and after the treatment as well as during the follow-up study,each patient of the 2 groups was submitted to determination of the body weight,waist-hip ratio,blood lipids(TC,TG),liver function(ALT,AST GGT) as well as B-mode ultrasonic examination.Routine examinations of the stool,urine and blood,renal function tests and ECG examination were carried out for all of the patients before and after the treatment. Results Striking improvement in body weight,waist-hip ratio,liver function,blood lipids and the state of the fatty liver as revealed by B-mode ultrasonography was demonstrated in patients of both groups after the treatment and during the follow-up study as compared with the corresponding results before the treatment(P0.05).The differences between patients of the two groups with respect to reduction of body weight and waist-hip ratio,improvement in liver function and decrement of serum total cholesterol(TC) were insignificant(P0.05).However,the amelioration of subjective symptoms,the extent of the decline of serum triglycerides(TG) and improvement in the state of fatty liver as revealed by B-mode ultrasonography in patients of the trial group were by far superior to those in patients of the control group(P0.05).During the follow-up study 3 months after the termination of the treatment,the extent of the decline of serum TG in patients of the trial group was still significantly greater than that in patients of the control group(P0.05). Conclusion KGZC was shown to reduce the body weight and waist-hip ratio,lower blood lipid level and improve liver function in patients with fatty liver.No major adverse reactions were encountered.It is therefore a safe and effective traditional Chinese medicine for the treatment of fatty liver.