To observe the therapeutic effect of Fangji Huangqi Decoction+Wuling Powder on patients with knee osteoarthritis(KOA).Methods:A total of 100 patients with KOA treated in the Wangjing Hospital of China Academy of Chinese Medical Sciences from July 2021 to December 2022 were randomized into a control group(n=50) and an observation group(n=50).The control group received routine treatment，and the observation group received Fangji Huangqi Decoction+Wuling Powder on the basis of routine treatment.Both groups were treated for 2 courses(six weeks per course).The clinical effects of the two groups were compared after treatment.The inflammation status ［tumor necrosis factor-alpha(TNF-α)，interleukin-17(IL-17)，and IL-1β］，knee joint function ［Lysholm score and Japanese Orthopaedic Association(JOA) score］，TCM symptom scores were determined before and after treatment.The adverse reactions occurred during the treatment period were recorded and analyzed.Results:After two courses of treatment，the clinical efficacy of the observation group was higher than that of the control group(P<0.05).The treatment in both groups lowered the levels of inflammatory cytokines and TCM symptom scores，and the observation group had lower levels of inflammatory cytokines and TCM symptom scores than the control group(P<0.05).The Lysholm score and JOA score in the two groups increased after treatment and were higher in the observation group than in the control group(P<0.05).Neither group showed serious adverse reactions during the treatment period.Conclusion:Fangji Huangqi Decoction combined with Wuling Powder can significantly reduce the inflammation，improve the knee joint function，relieve the pain，and improve the clinical efficacy for KOA with high safety.