Abstract: OBJECTIVE To observe the clinical efficacy of Qingli Xiezhuo Qutong Decoction in combination with Western medicine for the treatment of acute gouty arthritis with damp-heat accumulation syndrome. METHODS 70 patients were randomly divided into the control group and the treatment groups with 35 cases each. The control group was given colchicine tablets orally at an initial dose of 1 mg， followed by 0.5 mg per hour and 0.5 mg at a time， for 3 times per day when symptom was relieved， and the treatment group was given Qingli Xiezhuo Qutong Decoction one dose a day. Both groups were treated for 7 days. The joint pain score， joint swelling score， and traditional Chinese medicine (TCM) syndrome score were recorded before and after treatment， and blood leukocyte (WBC)， erythrocyte sedimentation rate (ESR)， C-reactive protein (CRP)， blood uric acid (BUA)， tumor necrosis factor-α (TNF-α)， interleukin-1 (IL-1) levels were tested before and after treatment， and safety evaluation was conducted. RESULTS The clinical efficacy of the treatment group was better than that of the control group after treatment (P<0.05). Joint pain score， joint swelling score， TCM syndrome score and CRP， ESA， TNF-α， IL-1， BUA levels were significantly reduced in both groups (P<0.01) and the treatment group was better than the control group (P<0.05， P<0.01). CONCLUSION On the basis of colchicine， Qingli Xiezhuo Qutong Decoction for acute gouty arthritis (damp-heat accumulation syndrome) can effectively relieve the main clinical symptoms reducing the inflammatory response， with better safety and clinical efficacy than that of pure western medicine.