Status:
COMPLETED
Efficacy of Omija (Schisandra Chinensis) Extract in Subjects With Knee Osteoarthritis
Lead Sponsor:
Chonbuk National University Hospital
Conditions:
Mild Knee Osteoarthritis
Eligibility:
All Genders
30-70 years
Phase:
PHASE2
PHASE3
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, as...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01472822
Start Date
March 1 2011
End Date
December 1 2011
Last Update
February 4 2013
Active Locations (1)
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1
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea, 560-822