Objective: To explore the clinical efficacy and safety of Da Huoluowan in treatment of early-to-middle stage osteonecrosis of femoral head (ONFH) with phlegm stasis syndrome. Method: A total of 180 (317 hips) eligible patients were randomly divided into the traditional Chinese medicine (TCM) group

western medicine group and TCM combined with western medicine group

60 cases in each group. The TCM group was treated with Da Huoluowan

western medicine group was treated with diclofenac sodium sustained-release tablets

and Da Huoluowan combined with diclofenac sodium sustained-release tablets was adopted in the TCM combined with western medicine group. The treatment course was 6 months

and the patients were followed up for 6 months.The harris hip joint function scale (Harris)

imaging index scale and TCM syndrome scores were applied to estimate the efficacy in the three groups before and after treatment.The changes of serum interleukin-1β (IL-1β)

tumor necrosis factor-α (TNF-α)

superoxide dismutase (SOD) and C-reactive protein (CRP) were detected

and then the effective rate

recurrence in 6 months of follow-up and safety indexes were compared among groups. Result: The 3 cases (5 hips) withdrew from TCM group

5 cases (8 hips) withdrew from western medicine group

and 4 cases (7 hips) withdrew from the TCM combined with western medicine group. The total effective rate in TCM combined with western medicine group was higher than the TCM group and the western medicine group (P<0.05). After treatment

the improvement in Harris scores

serum IL-1β

TNF-α

SOD and CRP levels in the TCM combined with western medicine group was significantly superior to that in TCM group and western medicine group (P<0.05)

but there was no significant difference between TCM group and western medicine group. The recurrence rate in follow-up of effective patients was as follows:western medicine group < TCM group < TCM combined with western medicine group (P<0.05)

and the safety was as follows:western medicine group < TCM combined with western medicine group < TCM group. Conclusion: There was no significant difference in clinical efficacy between Da Huoluowan and diclofenac sodium sustained-release tablets in treatment of ONFH with phlegm stasis syndrome

indicating the effectiveness of Da Huoluowan. In addition

it had a higher safety than diclofenac sodium sustained-release tablets. Da Huoluowan combined with diclofenac sodium sustained-release tablets showed synergistic Effect and could reduce the incidence of adverse reactions of diclofenac sodium sustained-release tablets.