Efficacy of Omija (Schisandra Chinensis) Extract in Subjects With Knee Osteoarthritis (NCT01472822) | Clinical Trial Compass
CompletedPhase 2/3
Efficacy of Omija (Schisandra Chinensis) Extract in Subjects With Knee Osteoarthritis
South Korea60 participantsStarted 2011-03
Plain-language 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.
Who can participate
Age range30 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
What they're measuring
1
Changes in WOMAC (Western Ontario and McMaster University Osteoarthritis Index) Totol Score