Objective To observe the clinical effect and safety of Yishen Juanbi Capsule（ 蚁参蠲痹胶囊） on active rheumatoid arthritis with kidney-Qi deficiency-cold syndrome. Methods Seventy cases of rheumatoid arthritis with kidney-Qi deficiency-cold syndrome were collected and randomly divided into a control group and a treatment group

with 35 patients in each group. All the patients were given with methotrexate（ 10 mg

once per week）

leflunomide（ 10 mg

once a day）

and celecoxib as needed（ 0. 2 g

once a day）. And the patients in the treatment group were also given Yishen Juanbi Capsule（ 2 g

three times a day）. The total course was two months. After that

the Chinese medicine syndrome score

morning stiff duration

mean grip strength of the two hands

Disease Activity Score-28（ DAS-28）

and health assessment questionnaire（ HAQ） score before and after the treatment in the two group were compared. Besides

changes of erythrocyte sedimentation rate（ ESR）

high-sensitivity C-reactive protein（ hs-CRP）

rheumatoid factors（ RF）

interleukin-6（ IL-6）

and proteoglycan（ PG） in synovial fluid in the two groups were also compared. The doses of celecoxib and the side effects were observed

and the effect on Chinese medicine syndrome was evaluated. Results The total effective rate for Chinese medicine syndrome was 93. 94% in the treatment group

which was significantly higher than 75. 00% in the control group（ P < 0. 05）. After treatment

the number of tender joints

the number of swelling joints

morning stiff duration

visual analogue scale（ VAS）

HAQ score

DAS28 score

and blood levels of CRP

ESR

RF

IL-6 and PG all significantly decreased in both groups. The mean grip strength of the two hands increased in both groups（ P < 0. 01）. Compared with the control group

the number of tender joints

the number of swelling joints

morning stiff duration

visual analogue scale（ VAS）

HAQ score

DAS28 score

and blood levels of CRP

ESR

RF

IL-6 and PG in the treatment group were more decreased（ P < 0. 05）. Compared with the control group

the mean grip strength of the two hands in the treatment group were more increased（ P < 0. 05）. Dose of celecoxib used in the treatment group was less than that in the control group（ P < 0. 05）. There were no significantly differences between the side effects in the two groups（ P >0. 05）. Conclusion Yishen Juanbi Capsule could improve the symptoms of rheumatoid arthritis with kidney-Qi deficiency-cold syndrome

and have good safety.