Abstract: Objective: To observe the effect of Wenjing Sanhan Formula on the traditional Chinese medicine syndrome scores, affected joint function and immune inflammatory indexes in patients with rheumatoid arthritis (RA) of wind- cold damp impediment type. Methods: A total of 142 RA patients of wind-cold-damp impediment type were selected as the research objects,and were randomly divided into the Wenjing Sanhan Formula Group and the Methotrexate Group, with 72 and 70 cases in each group respectively. The Methotrexate Group was simply treated with Methotrexate Tablets orally, and the Wenjing Sanhan Formula Group was additionally treated with Wenjing Sanhan Decoction based on the treatment of the Methotrexate Group. The changes of traditional Chinese medicine (TCM) syndrome scores, affected joint function, immune inflammatory indexes and serum related indexes of RA were compared between the two groups before and after treatment. Results:Before treatment,there was no significant difference in the TCM syndrome scores of morning stiffness, joint pain, joint swelling, joint deformity, tongue manifestation and pulse manifestation between the two groups (P>0.05); after treatment, the scores of the above TCM syndromes in both groups were decreased (P<0.05), and the score in the Wenjing Sanhan Formula Group was lower than that in the Methotrexate Group (P<0.05). Before treatment,there was no significant difference in the score of RA Disease Activity Score-28 (DAS28) between the two groups (P>0.05); after one month of treatment and two months of treatment, the DAS28 scores in both groups were decreased (P<0.05), and the score in the Wenjing Sanhan Formula Group was lower than that in the Methotrexate Group (P<0.05). Before treatment,there was no significant difference in the levels of C-reactive protein (CRP), tumor necrosis factor- α (TNF- α) and interleukin- 1 (IL-1) between the two groups (P>0.05);after treatment,the levels of CRP,TNF-α and IL-1 in the two groups were decreased (P<0.05),and the above levels in the Wenjing Sanhan Formula Group were lower than those in the Methotrexate Group (P<0.05). Before treatment,there was no significant difference in the levels of serum erythrocyte sedimentation rate (ESR),rheumatoid factor (RF),matrix metalloproteinase-3 (MMP-3) and osteoptin (OPG) between the two groups (P>0.05);after treatment,the levels of serum ESR, RF and MMP- 3 in the two groups were decreased (P<0.05), and the serum OPG levels were increased (P<0.05); the levels of ESR, RF and MMP- 3 in the Wenjing Sanhan Formula Group were lower than those in the Methotrexate Group (P<0.05),and the serum OPG level in the Wenjing Sanhan Formula Group was higher than that in the Methotrexate Group (P<0.05). Conclusion: Wenjing Sanhan Formula can reduce the TCM syndromes of RA patients of wind-cold-damp impediment type, which is conducive to restoring the joint function of patients, alleviating inflammation and promoting bone recovery.