Objective: To investigate the compatibility of a modified prescription of Simiao Pill (四妙丸) in the treatment of acute gouty arthritis and to verify the clinical efficacy and safety of the drug through a clinical trial. Methods: A randomized and controlled clinical trial was designed based on clinical epidemiological principles, A total of 107 patients with acute gouty arthritis were enrolled and randomly assigned to four groups. The first group (Group Ⅰ) included 27 patients taking gout prescription Ⅰ ; the second group (Group Ⅱ) included 27 patients taking gout prescription Ⅱ ; the third group (Group Ⅲ) included 28 patients taking gout prescription Ⅲ; and the fourth group (control group) included 25 patients taking indomethacin and Benzobromarone as a control group. The duration of the treatment in all 4 groups was two weeks. After the treatment, the index of blood uric acid, blood leukocyte count, score of clinical symptoms, etc. were observed and measured. Results: The total clinical effective rate of the three different modified prescriptions of the Simiao Pill was above 96%,significantly superior to that of the control group (68%, P