Shugan Quzhi capsule is a hospital preparation of Xinhua Hospital affiliated to School of Medicine, Shanghai Jiaotong University. It has been used to treat adult patients with fatty liver caused by obesity, high cholesterol and other factors. In the present study, we investigated the clinical efficacy and safety of Shugan Quzhi capsule in adult simple obesity. The patients were randomly divided into the treatment group and control group. The whole treatment lasted 2 months under the same nutritional condition and diet intervention. Body weight, body mass index, total cholesterol, triglyceride, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, alanine aminotransferase, aspartate aminotransferase, blood urea nitrogen, creatinine, urine and blood routine examination were recorded before and after treatment. Our data showed that the total effective rate of treatment group was 66.67%, and body weight and body mass index after treatment the body were significantly decreased (P〈0.01). The levels of total cholesterol, triglyceride, high-density lipoprotein and low-density lipoprotein after treatment were lower than before treatment, but there was no statistical difference (P〉0.05). The total effective rate of control group was 39.13%, and the body weight and body mass index atter treatment were also significantly lower than before (P〈0.01). There was no significant difference between the treatment group and control group (P〉0.05). There were no significant changes in liver function, renal function, urine routine and blood routine examination data after treatment. The results suggested that Shugan Quzhi capsule had certain therapeutic efficacy and safety in adult simple obesity.