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Objective: To study the clinical efficacy of Suogudan Granule (SGDG, 索骨丹颗粒) in the treatment of rheumatoid arthritis (RA). Methods: Ninety patients with RA were randomly divided into the treated group and the control group. The treated group was administered orally with SGDG 6 g each time,thrice a day, while the control group with the combined therapy of Fenbid Capsules 0.3 g each time, twice a day and Tripterygium tablet 20 mg each time, thrice a day. The treatment course for both groups was 6 weeks. The changes of clinical symptoms and signs, and laboratory indices such as erythrocyte sedimentation rate (ESR), rheumatoid factor (RF), antistreptolysin O (ASO), routine examination of blood and urine,liver and kidney function, etc. before and after treatment were observed. Results: (1) The total effective rate in the treated group (88.0%) was obviously higher than that in the control group (67.5 %) with significant difference ( P＜0.05). (2) The improvement in arthralgia, joint swelling, time of ming stiffness, 15-meter walking, analgesia initiation and persistence in the treated group was better than that in the control group ( P＜0.05, P＜0.01), but there was no obvious difference in improvement of joint tendess, range of joint motion, grip strength, and initiating detumescence time ( P＞0.05 ). (3) The improvement in ESR and RF in the treated group was better than that in the control group with significant difference ( P＜0.05). The negative-conversion rate of ASO in the treated group was also higher than that in the control group ( P＜0.01 ).(4) No evident abnormality in blood, urine, liver or kidney function was found in either group. Conclusion:SGDG is effective and safe for the treatment of RA.