Background/Purpose: In recent years, the combination therapies of conventional synthetic disease-modifying antirheumatic drugs (cDMARDs) with Chinses medicine has prevailed for the treatment of rheumatoid arthritis (RA) in China. The objective of this pilot study was to assess the efficacy and safety of Biqi capsule, a Chinses herbal medicine combined with methotrexate (MTX) against patients with rheumatoid arthritis (RA) comparing with the combination therapy of MTX with Leflunomide (LEF). Methods: This was a multicenter, open-label, randomized, parallel controlled trial with 24-week course on the treatment of RA. Total of 70 participates with RA were randomly assigned at a ratio of 1:1 to received Biqi capsule at a dose of 1.2g twice daily, or LEF at a dose of 20mg once daily in addition to MTX treatment. The primary outcome was the rate of achievement of 20% improvement in the American College of Rheumatology criteria (ACR 20) at 24 weeks. Secondary outcomes included the ACR50 and ACR70 responses, EULAR response, the side effects of the medications, 28-tender joint count (TJC28), 28-swollen joint count (SJC28), patient’s assessment of pain (VAS), patient’s and physician’s global assessment of disease activity (PaGADA/PhGADA), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), rheumatoid factor(RF) and health assessment questionnaire (HAQ) score. Efficacy and safety were assessed after 4, 12 and 24 weeks of follow-up. Results: 59/70 (84.3%) patients completed 24 weeks of the study. In an intention-to-treat analysis (ITT), ACR20 response was attained in 27 (77.1%) of 35 patients with MTX+Biqi treatment and 29 (82.9%) of 35 patients with MTX+LEF treatment at 24 weeks (p=0.550). Importantly, fewer adverse events were found in patients treated with Biqi+MTX compared to patients with MTX+LEF (p< 0.05). Conclusion: With a beneficial clinical response and acceptable tolerability, our study suggested that Biqi capsule appeared to be a promising alternative option in combination with MTX in RA treatment.