Objective To investigate the clinical efficacy of self-made Wenshen Yunpi decoction in gout patients with spleen and kidney yang deficiency-cold dampness stasis. Methods The 86 patients who met the inclusion criteria were randomly divided into control group and treatment group

with 43 cases in each group. The control group was given conventional western medicine treatment

and the treatment group was treated with self-made Wenshen Yunpi decoction in addition to the treatment for the control group; the course of treatment was 1 month for both groups. The scores of joint symptoms and signs

traditional Chinese medicine syndrome scores

levels of blood uric acid and C-reactive protein

erythrocyte sedimentation rate

recurrence rate

and overall response rate were compared between the two groups of patients. Results After 1 month of treatment

the treatment group had significantly lower scores of joint symptoms and signs

levels of blood uric acid and C-reactive protein

erythrocyte sedimentation rate

and recurrence rate and a significantly higher overall response rate compared with the control group（P <0.05）. Conclusion The self-made Wenshen Yunpi decoction can improve the clinical symptoms of gout patients with spleen and kidney Yang deficiency-cold dampness stasis

and its combination with western medicine is more effective than western medicine alone.