Objective To observe clinical curative effects and safety of Fufang Tufuling Keli（ 复方土茯苓颗粒）treating hyperuricemia. Methods Randomly divided 60 cases of patients with hyperuricemia into the control group

the short-term group and the long-term group

with 20 cases each. The control group was only given treatment measures like health education and low purine diet for 12 months; The short-term group took Fufang Tufuling Keli orally based on that of the control group

10 g every time

twice per day and 20 days was a treatment course. There were 10-day intervals between two courses. The treatment was for 3 months in total

after which 9-months basic treatment was conducted. The long-term group took 10 days for a treatment course from the fourth month bases on treatment of the short-term group. There was a 20-day interval between two courses. Nine more courses were conducted

with 12 months in total. Collected clinical four diagnostic information of Chinese medicine

and scored for Chinese medicine symptoms. At baseline and at the third and 12 th month during treatment

examined safety indexes（ including tests of serum uric acid

blood routine

urine routine

liver function and kidney function）. Results Serum uric level of patients in 3 groups in the third and the 12 th month during treatment decreased compared with that before treatment（ P < 0. 01）. The degree of serum uric decreasing of the short-term group and the long-term group was both superior to that of the control group（ P < 0. 05 or P < 0. 01）. And the long-term group was superior to the short-term group after 12 months treatment（ P < 0. 05）. Integration of sputum

physically and mentally fatigued

limbs heaviness and urine color of patients in the short-term and long-term group all decreased in the third month during treatment

while that of urine volume all increased（ P < 0. 05 or P < 0. 01）. Above symptoms of the long-term group still continued to improve after treatment for 12 months. Index including blood routine

urine routine

liver function and kidney function of patients in 3 groups in the third and 12 th month had no statistical difference compared with that before treatment（ P > 0. 05）. Conclusion Fufang Tufuling Keli could effectively decreased serum urine level of patients with hyperuricemia

and could improve clinical symptom of Chinese medicine related to phlegm dampness stagnation with good long-term effect and safety.