to investigate effectiveness and safety of self-formulated umbilicus applied Shaotong Sanhua San for treatment of rheumatic arthritis (RA). Methods:300 RA patients were randomly divided to treated group (200 cases) applied with the powder, and control group (100 cases) orally given MTX and Naproxen. Results:the treated group showed an excellent rate of 55.00% (110 cases) and an effective rate 30.0% (60 cases) in comparison with the control group’s excellent rate of 25.77% (25 cases) and effective rate of 39.18% (38 cases). The difference was significant (P<0.01). Both groups, in such indices as swelling, tenderness, grip strength, morning stiffness, general marks for joint function improved significantly after treatment. In the meantime the treated group remarkably excelled the control group. Conclusion:the self-formulated umbilicus applied Shaotong Sanhua San is immediately effective and adverse function free for treating RA.