Objective:To determine the effects of Chinese medicine (CM) involving triple rehabilitation therapy on the progression of knee osteoarthritis (KOA).Methods:A total of 722 patients recruited from 38 community health service centers located in China from March 2013 to March 2017 were randomly divided into treatment and control groups equally,using a cluster randomization design.Health education combined with CM involving triple rehabilitation therapy for KOA (electro-acupuncture,Chinese medicinal herb fumigating-washing,and traditional exercises) was administered in the treatment group while conventional rehabilitation therapy (physical factor therapy,joint movement training,and muscle strength training) was administered in the control group.Patients with a visual analog scale (VAS) scores ≥4 were treated with dispersible meloxicam tablets (7.5 mg,once daily).The Lequesne index scores,VAS scores,range of motion (ROM),lower limb muscle strength,knee joint circumference,quantitative scores of KOA symptoms,and the short-form 36 item health survey questionnaire (SF-36) scores were measured for each patient at 5 checkpoints (before treatment,at the 2nd week and the 4th week during the 4-week treatment period,at 1 month and 3 months after end of treatment),and adverse reactions were observed also.Results:A total of 696 patients completed the entire process,with 351 in the treatment group and 345 in the control group.At all treatment checkpoints,the treatment group demonstrated better outcomes than the control group with regard to the total Lequesne index scores,effective rate and improvement rate of the total Lequesne index scores,VAS scores,lower limb muscle strength,knee circumference,quantitative scores of KOA symptoms,and SF-36 scores as well (P＜0.05 or P＜0.01).No adverse reactions were encountered in this study.Conclusions:CM involving triple rehabilitation therapy can alleviate KOA-related pain and swelling,improve lower limb muscle strength,promote flexion and activity of the knee and improve the quality of life in patients undergoing KOA.It is suitable for patients with early or mid-stage KOA.(Registration No.ChiCTR-TRC-12002538)