Clinical trial NCT01472822: Efficacy of Omija (Schisandra Chinensis) Extract in Subjects With Knee Osteoarthritis
Official title: Efficacy and Safety of Omija Extract on Gonarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Mild Knee Osteoarthritis
Keywords: Omija
knee osteoarthritis
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2011-11-17
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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)

Primary outcomes:
measure: Changes in WOMAC (Western Ontario and McMaster University Osteoarthritis Index) Totol Score
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in Lysholm Index Score
timeFrame: 12 weeks
measure: Changes in Hs-CRP(High Sensitivity C-reactive Protein)
timeFrame: 12 weeks
measure: Changes in OSC(Osteocalcin)
timeFrame: 12 weeks
measure: Changes in DPD(Deoxypyridinoline)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
affiliation: Chonbuk National University Hospital
name: Jeong-Hwan Seo, MD
role: PRINCIPAL_INVESTIGATOR
References: