To evaluate the efficacy, clinical characteristics and relevant laboratory variables of JianPi ShuGan JiangZhi Formula in the treatment of simple obesity. Methods:In our prospective, double-blind, randomized, controlled clinical trial, a total of 68 patients with simple obesity were randomly divided into JianPi ShuGan JiangZhi Formula group (the experimental group, given JianPi ShuGan JiangZhi Formula treatment) and placebo group (the control group). The treatment lasted for 28 days. The clinical response, body mass index(BMI), TCM syndrome score, serum level of total cholesterol (TC), glycerin three greases (TG), low density lipoprotein cholesterol (LDL-C) and high density lipoprotein cholesterol (HDL-C), and the expression of leptin/adiponectin after treatment were observed in both groups. Results:After 28 days’ treatment, the clinical efficacy and all the laboratory indexes (except of adiponectin) were superior in the experimental group to those in the control group(P<0.05). There was no statistical difference in the level of adiponectin expression between the two groups(P>0.05). Conclusion:JianPi ShuGan JiangZhi Formula is effective for simple obesity caused by liver stagnation and spleen deficiency. It can improve the BMI index, reduce serum level of TC, TG,LDL-C and Leptin expression, and increase serum level of HDL-C.