Abstract:Objective To observe the clinical efficacy and safety of Yishen Qingluo Huoxue Prescription (for kidney- nourishing, collateral- dredging, and blood- activating purposes) in the treatment of rheumatoid arthritis (RA) with syndrome of intermingled phlegm and blood stasis. Methods Sixty patients with RA and syndrome of intermingled phlegm and blood stasis were randomly and equally divided into experimental group and control group(One patient in experimental group was lost to follow- up). Patients in the experimental group and the control group received oral administration of Yishen Qingluo Huoxue Prescription and leflunomide, respectively, for 90 continuous days. Rheumatoid factors (RF), erythrocyte sedimentation rate (ESR), C- reactive protein (CRP), anti- cyclic citrullinated peptide (CCP) antibody, dual grip strength, joint tenderness index, and joint swelling index were evaluated in both groups before and after treatment. Pain was scored using the visual analogue scale (VAS). The quality of life was assessed using the health assessment questionnaire (HAQ). The changes in routine blood indices, routine urine indices, routine feces indices, liver function, renal function, and electrocardiogram were monitored. Results In both groups, RF, CRP, ESR, anti- CCP antibody, joint tenderness index, joint swelling index, VAS score, and HAQ score were significantly improved after treatment (P<0.05). Dual grip strength was significantly increased after treatment in the experimental group (P<0.05) rather than the control group (P>0.05). The reduction in CRP, ESR, and VAS score in the control group was significantly superior to that in the experimental group (P<0.05). There were no significant differences in traditional Chinese medicine syndrome outcomes between the two groups (P>0.05). There were no adverse reactions in both groups. Conclusions Yishen Qingluo Huoxue Prescription achieves substantial short- term efficacy in the treatment of RA with syndrome of intermingled phlegm and blood stasis, which is quite similar to that of leflunomide.