Objective To observe the efficacy and safety of Juanbi Granules combined with methotrexate（ MTX）for active rheumatoid arthritis（ RA）.Methods Totally 209 active RA patients with wind-cold-dampness arthralgia syndrome were randomized into the treatment group of 140 patients and control group of 69 patients.Both groups were given 10 mg of MTX once weekly.The treatment group was added with Juanbi Granules three times daily.The control group was added with Zhengqing Fengtongning sustained-release tablets twice daily.The treatment lasted for 8 weeks.The efficacy and traditional Chinese medicine（ TCM） syndrome efficacy were observed.The Disease Activity Score28（ DAS28）

Clinical Disease Activity Index（ CDAI）

Simplified Disease Activity Index（ SDAI）

Swollen Joint Count 28（ SJC28） and Tender Joint Count 28（ TJC28） were compared.The pain score

Patient Global Assessment（ PGA） and Physician Global Assessment（ MDGA） were observed.The levels of erythrocyte sedimentation rate（ ESR） and C-reactive protein（ CRP） were detected.Results The efficacy and TCM syndrome efficacy in the treatment group were superior to those in the control group（ P < 0.05 or P < 0.01）.Both groups were significantly improved in DAS28

CDAI

SDAI

SJC28

TJC28

pain score

PGA

MDGA

ESR and CRP after treatment（ P <0.01）

especially treatment group in DAS28

CDAI

SDAI

SJC28

TJC28

pain score

PGA and MDGA（ P <0.01）.There was no adverse reaction in both groups.Conclusion Juanbi Granules combined with MTX can obviously relieve symptoms and disease activity of active RA with a good safety.