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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Soo-Wan Chae, Chonbuk National University Hospital
ClinicalTrials.gov Identifier:
NCT01472822
First received: November 14, 2011
Last updated: December 27, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Mild Knee Osteoarthritis
Dietary Supplement: Omija extract.
Dietary Supplement: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Efficacy and Safety of Omija Extract on Gonarthritis

Resource links provided by NLM:


Further study details as provided by Chonbuk National University Hospital:

Primary Outcome Measures:
  • Changes in WOMAC (Western Ontario and McMaster University Osteoarthritis Index) Totol Score [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

    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 Outcome Measures:
  • Changes in Lysholm Index Score [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

    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).


  • Changes in Hs-CRP(High Sensitivity C-reactive Protein) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    hs-CRP(high sensitivity C-reactive protein) was measured in study visit 1(0 week) and visit 3(12 week).

  • Changes in OSC(Osteocalcin) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    OSC(Osteocalcin) was measured in study visit 1(0 week) and visit 3(12 week).

  • Changes in DPD(Deoxypyridinoline) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    DPD(Deoxypyridinoline) was measured in study visit 1(0 week) and visit 3(12 week).


Enrollment: 60
Study Start Date: March 2011
Study Completion Date: December 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Omija extract. Dietary Supplement: Omija extract.
Omija extract 1.2g/day for 12weeks
Placebo Comparator: Placebo Dietary Supplement: Placebo
Placebo 1.2g/day for 12weeks

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

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01472822

Locations
Korea, Republic of
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
Sponsors and Collaborators
Chonbuk National University Hospital
Investigators
Principal Investigator: Jeong-Hwan Seo, MD Chonbuk National University Hospital
  More Information

No publications provided

Responsible Party: Soo-Wan Chae, Clinical Trial Center for Functional Foods, Chonbuk National University Hospital
ClinicalTrials.gov Identifier: NCT01472822     History of Changes
Other Study ID Numbers: BIOYD-KA-SCHISANDRA
Study First Received: November 14, 2011
Results First Received: July 26, 2012
Last Updated: December 27, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by Chonbuk National University Hospital:
Omija
knee osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 22, 2014