KEYWORDS 2 Bi Qi capsule, Knee osteoarthritis, randomized controlled trial 3 Abstract Objective: To evaluate the efficacy and tolerability of Bi Qi capsule in knee osteoarthritis. Patients and methods: An open-label, 24-week, parallel randomized controlled trial conducted between October 2016 to October 2018. Patients with knee osteoarthritis were randomly assigned 1:1 to receive Bi Qi capsule (1.2g, twice a day) and Calcitriol capsule (0.25ug, once a day). Western Ontario and McMaster

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... ies Osteoarthritis (WOMAC) was the primary outcome, including pain, stiffness, and function subscale scores. Secondary outcome measures were visual analogue scale (VAS) score for the patients assessment of pain, bone mineral density (BMD), patient's assessment of function using the Health Assessment Questionnaire (HAQ). Safety was assessed by recording adverse events (AEs). Results: 100 patients were included in the study. 15(15%) patients discontinued the study because of lack of efficacy, adverse events and loss of follow up. At the end of the treatment ,the decrease in WOMAC total score was -8.7(4.9) and -5.4(5.6) and improvement of WOMAC function was -4.88(3.6) and -2.70(3.86) in the Bi Qi group and the controlled group, respectively (p 0.01). The improvement in BMD of left femoral neck was 0.05(0.2) and -0.01(0.04) , improvement in T score of left femoral neck was 0.15(0.5) and -0.05(0.3) in the Bi Qi group and the controlled group, respectively (p 0.01). No significant difference was observed between treatment groups for changes in WOMAC pain, WOMAC stiffness, VAS, BMD of lumbar spine, T score of lumber spine and HAQ over 24 weeks. Two adverse events were reported in Bi Qi group: facial edema (n=1), nausea (n=1) and one adverse events was reported in controlled group: lip swelling (n=1). All these adverse events were mild and could be alleviated after withdrawing treatment. Conclusion: It can be concluded that Bi Qi capsule was found to be effective and safe in reducing WOMAC total score, improving WOMAC function and BMD in individuals suffering from KOA.