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

Study Overview
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Brief Summary
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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
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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).

Official Title
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Efficacy and Safety of Omija Extract on Gonarthritis

Conditions
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Mild Knee Osteoarthritis

Intervention / Treatment
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* Dietary Supplement: Omija extract.
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omija extract.<br> | Dietary Supplement: Omija extract.<br>* Omija extract 1.2g/day for 12weeks<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* Placebo 1.2g/day for 12weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in WOMAC (Western Ontario and McMaster University Osteoarthritis Index) Totol Score | 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). | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Lysholm Index Score | 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). | 12 weeks | 
| Changes in Hs-CRP(High Sensitivity C-reactive Protein) | hs-CRP(high sensitivity C-reactive protein) was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks | 
| Changes in OSC(Osteocalcin) | OSC(Osteocalcin) was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks | 
| Changes in DPD(Deoxypyridinoline) | DPD(Deoxypyridinoline) was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Omija, knee osteoarthritis