Abstract: OBJECTIVE To observe the clinical effect and safety of treatment of Gushibao pill on severe kidney circulation deficiency and blood stasis type knee osteoarthritis. METHODS 70 patients with severe knee osteoarthritis were selected for this study， and were divided into the treatment group (38 cases) and the control group (32 cases). Patients of two groups were given health education and basic knee stick therapy treatment. On the basis of basic treatment， patients in the control group were given glucosamine hydrochloride capsules orally and treatment group were give Gubaoshi pill. WOMAC Osteoarthritis Index Scale and ISOA knee osteoarthritis severity index scale were used to evaluate the outcomes of two groups. Chinese medicine symptom score were used to evaluate the clinical symptoms. ESR， calcitonin (CT) and bone alkaline phosphatase (BALP) were detected before and after treatment. RESULTS Erythrocyte sedimentation rate in the control group significantly decreased after a course of treatment (P<0.05)， and bone alkaline phosphatase and calcitonin showed no significant change(P>0.05). Erythrocyte sedimentation rate decreased significantly in treatment group after treatment (P<0.05)， and bone alkaline phosphatase and calcitonin showed no significant change (P>0.05). Scored of symptoms and signs significantly decreased in two groups， and the decreased extent of treatment group was significantly greater than that of the control group (P<0.05). Pain score， WOMAC score and ISOA scores were significantly lower in two groups of patients compared with the condition before treatment (P<0.05). After treatment， pain score， WOMAC score and ISOA scores of treatment group were lower than those of the control group (P<0.05). The total effective rate of treatment group was 97.37%， and was significantly higher than the control group (80.00%). The difference was statistically significant (P<0.05). Two patients had no obvious adverse reactions during treatment. CONCLUSION Gushibao pill can decrease the level of erythrocyte sedimentation rate in patients with severe kidney circulation deficiency and blood stasis knee osteoarthritis. It is effective and safe.