Efficacy and Safety of Omija Extract on Gonarthritis
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Changes in WOMAC (Western Ontario and McMaster University Osteoarthritis Index) Totol Score
Study Overview
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, 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
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 30 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Arms & Interventions
Omija extract.
Intervention: Omija extract. (Dietary Supplement)
Placebo
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
Changes in WOMAC (Western Ontario and McMaster University Osteoarthritis Index) Totol Score
Time Frame: 12 weeks
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).
Secondary Outcomes
- Changes in Lysholm Index Score(12 weeks)
- Changes in Hs-CRP(High Sensitivity C-reactive Protein)(12 weeks)
- Changes in OSC(Osteocalcin)(12 weeks)
- Changes in DPD(Deoxypyridinoline)(12 weeks)
Investigators
Soo-Wan Chae
Clinical Trial Center for Functional Foods
Chonbuk National University Hospital