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

NCT ID: NCT01472822

Last Updated: 2013-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2011-12-31

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).

Conditions

Mild Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Omija extract.

Group Type: EXPERIMENTAL

Omija extract.

Intervention Type: DIETARY_SUPPLEMENT

Omija extract 1.2g/day for 12weeks

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo 1.2g/day for 12weeks

Interventions

Omija extract.

Omija extract 1.2g/day for 12weeks

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo 1.2g/day for 12weeks

Intervention Type: DIETARY_SUPPLEMENT

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)

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chonbuk National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Soo-Wan Chae

Clinical Trial Center for Functional Foods

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeong-Hwan Seo, MD

Role: PRINCIPAL_INVESTIGATOR

Chonbuk National University Hospital

Locations

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Countries

South Korea

Other Identifiers

BIOYD-KA-SCHISANDRA

Identifier Type: -

Identifier Source: org_study_id