Objective  To observe the clinical efficacy of Yunpi Huazhuo Granule in the treatment of non-alcoholic fatty liver disease (NAFLD) differentiated as heat-accumulation in stomach and injury of spleen function.

  Methods  A total of 92 NAFLD patients with heat-accumulation in stomach and injury of spleen function were enrolled, and were randomly divided into treatment group (n=46) and control group (n=46) by the random number table method. The patients of two groups were given lifestyle intervention such as health education, diet control, strengthened exercise, the control group was additionally given oral metformin hydrochloride for 250 mg, and the treatment group was given Yunpi Huazhuo Granule based on the control group. Clinical symptom scores, waist circumference, body weight, body mass index(BMI), total cholesterol (TC), triglyceride (TG), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), alanine aminotransferase (ALT), aspartate amino transferase (AST) before and after treatment in the two groups were observed.

  Results  The patients in both groups had significantly improved clinical symptom scores, and reduced TC, TG, ALT, AST, waist circumference, body weight, BMI, and the treatment group was better than the control group(P < 0.05).

  Conclusion  Lifestyle intervention such as health education, diet control, exercise combined with oral administration of Yunpi Huazhuo Granule for patients with non-alcoholic fatty liver disease differentiated as heat-accumulation in stomach and injury of spleen function can improve the clinical symptoms, reduce TC, TG, ALT, AST, waist circumference, body weight, and BMI.