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

Efficacy and Safety of Omija Extract on Gonarthritis

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.

Study Overview

• Status: Completed
• Conditions: Mild Knee Osteoarthritis
• Intervention / Treatment: Dietary supplement: Omija extract.; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeollabuk-do
    • Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
      • Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; Placebo 1.2g/day for 12weeks
Experimental: Omija extract.	Dietary supplement: Omija extract.; Omija extract 1.2g/day for 12weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in WOMAC (Western Ontario and McMaster University Osteoarthritis Index) Totol Score	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).	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Lysholm Index Score	Lysholm index score total score (score 0-100) was measured in study visit 1(0 week) and visit 3(12 week). The original index consists of 9 Questions(Limp, Assive devices, Up stair, Giving way, Sauat, Sit down&up, Cripitation, Swelling, Pain). Lysholm index score total score summed to form a score ranging from 0 (worst) to 100 (best).	12 weeks
Changes in Hs-CRP(High Sensitivity C-reactive Protein)	hs-CRP(high sensitivity C-reactive protein) was measured in study visit 1(0 week) and visit 3(12 week).	12 weeks
Changes in OSC(Osteocalcin)	OSC(Osteocalcin) was measured in study visit 1(0 week) and visit 3(12 week).	12 weeks
Changes in DPD(Deoxypyridinoline)	DPD(Deoxypyridinoline) was measured in study visit 1(0 week) and visit 3(12 week).	12 weeks

Collaborators and Investigators

• Sponsor: Chonbuk National University Hospital
• Investigators: Principal Investigator: Jeong-Hwan Seo, MD, Chonbuk National University Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: November 14, 2011
• First Submitted That Met QC Criteria: November 16, 2011
• First Posted (Estimate): November 17, 2011

Study Record Updates

• Last Update Posted (Estimate): February 4, 2013
• Last Update Submitted That Met QC Criteria: December 27, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: knee osteoarthritis; Omija
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: BIOYD-KA-SCHISANDRA