Efficacy of Omija (Schisandra Chinensis) Extract in Subjects With Knee Osteoarthritis

In the present study, the investigators will assess the efficacy and safety of the formulation of Omija extract(1,200 mg administered twice a day) on the symptoms of knee osteoarthritis (KO) during a 12-week treatment course. In a randomized, double-blind placebo-controlled trial, subjects will be randomly assign to receive oral omija treatment group(n=30) or placebo group(n=30). The primary efficacy outcome measure will be score change in the WOMAC(Western Ontario and McMaster University Osteoarthritis Index) after 12-weeks. Secondary parameters will be included the Lysholm index score, hs-CRP, osteocalcin(OSC), and deoxypyridinoline(DPYR).

Inclusion criteria

• Males and females 30-70 years old
• mild to Moderate KO(Knee Osteoarthritis) as indicated by WOMAC(Western Ontario and McMaster University Osteoarthritis Index) score ≥ 38
• Able to walk
• Subject agrees not to start any new therapies for OA during the course of the study
• Able to give informed consent

Exclusion criteria

• History of underlying inflammatory arthropathy; septic arthritis; inflammatory joint disease; gout; pseudogout; Paget's disease; joint fracture; acromegaly; fibromyalgia; Wilson's disease; ochronosis; haemochromatosis; heritable arthritic disorder or collagen gene mutations or rheumatoid arthritis
• Expectation of surgery in the next 4 months
• Recent injury in the area affected by OA of the knee, i.e. meniscal tear (past 4 months)
• Cartilage reconstruction procedure in the target knee
• Intra-articular corticosteroid injections in the target knee within the last 3 months
• Viscous injections in the target knee within the last 6 months
• Abnormal liver or kidney function tests (ALT or AST > 2 times the upper limit of normal; elevated creatinine, males>125 umol/L, females>110 umol/L)