Phase 3
Completed N=60
Efficacy of Omija (Schisandra Chinensis) Extract in Subjects With Knee Osteoarthritis
Mild Knee Osteoarthritis
Source: ClinicalTrials.gov NCT01472822 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Feb 2013
Primary outcomePrimary: Changes in WOMAC (Western Ontario and McMaster University Osteoarthritis Index) Totol Score — 56.0; 53.3; 34.8; 31.5 Score
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in WOMAC (Western Ontario and McMaster University Osteoarthritis Index) Totol Score |
56.0; 53.3; 34.8; 31.5 | — |
| SECONDARY Changes in Lysholm Index Score |
52.6; 48.3; 54.8; 59.9 | — |
| SECONDARY Changes in Hs-CRP(High Sensitivity C-reactive Protein) |
0.3; 1.2; 0.5; 0.6 | — |
| SECONDARY Changes in OSC(Osteocalcin) |
16.5; 16.6; 16.8; 17.3 | — |
| SECONDARY Changes in DPD(Deoxypyridinoline) |
7.3; 7.2; 7.2; 7.5 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT01472822). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.