Phase 3 N=60 Randomized Double-blind Prevention

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

Mild Knee Osteoarthritis

Bottom Line

View on ClinicalTrials.gov: NCT01472822 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2013

Primary outcome: Primary: Changes in WOMAC (Western Ontario and McMaster University Osteoarthritis Index) Totol Score — 56.0; 53.3; 34.8; 31.5 Score

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Omija extract. (Dietary_supplement); Placebo (Dietary_supplement)
Age: Adult, Older Adult · 30+ yrs
Sex: All
Sponsor: Chonbuk National University Hospital
Primary completion: Jun 2011

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	—

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.

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)

View full record on ClinicalTrials.gov →

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.