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

Phase 2

Completed

Interventions: Dietary Supplement: Omija extract.
Dietary Supplement: Placebo

Brief Summary: Knee osteoarthritis (KO) is a common arthropathy and a leading cause of disability in elderly adults. Schizandra chinensis(Omija) has been known to have five predominant tastes: salty, sweet, sour, astringent, and bitter. It has also been shown to have various effects on the anti-inflammatory, cardiovascular system, gastrointestinal system, central nervous system, endocrine system, and stress protect. Therefore, this study is designed to evaluate the efficacy and safety on KO of Omija extract.

Detailed Description: 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).

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
Omija extract.	Omija extract.	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Changes in WOMAC (Western Ontario and McMaster University Osteoarthritis Index) Totol Score	12 weeks	WOMAC(Western Ontario and McMaster University Osteoarthritis Index) total score (score 0-96) was measured in study visit 1(0 week) and visit 3(12 week). The original index consists of 24 Questions. Individual question response is assigned a score of between 0 (none) to 4 (extreme) and summed to form a score ranging from 0 (best) to 96 (worst).

Secondary Outcome Measures

Name	Time	Method
Changes in Lysholm Index Score	12 weeks	Lysholm index score total score (score 0-100) was measured in study visit 1(0 week) and visit 3(12 week). The original index consists of 9 Questions(Limp, Assive devices, Up stair, Giving way, Sauat, Sit down\&up, Cripitation, Swelling, Pain). Lysholm index score total score summed to form a score ranging from 0 (worst) to 100 (best).
Changes in Hs-CRP(High Sensitivity C-reactive Protein)	12 weeks	hs-CRP(high sensitivity C-reactive protein) was measured in study visit 1(0 week) and visit 3(12 week).
Changes in OSC(Osteocalcin)	12 weeks	OSC(Osteocalcin) was measured in study visit 1(0 week) and visit 3(12 week).
Changes in DPD(Deoxypyridinoline)	12 weeks	DPD(Deoxypyridinoline) was measured in study visit 1(0 week) and visit 3(12 week).