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

Primary Purpose

Mild Knee Osteoarthritis

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Omija extract.
Placebo
Sponsored by
Chonbuk National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mild Knee Osteoarthritis focused on measuring Omija, knee osteoarthritis

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Omija extract.

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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).
Changes in OSC(Osteocalcin)
OSC(Osteocalcin) was measured in study visit 1(0 week) and visit 3(12 week).
Changes in DPD(Deoxypyridinoline)
DPD(Deoxypyridinoline) was measured in study visit 1(0 week) and visit 3(12 week).

Full Information

First Posted
November 14, 2011
Last Updated
December 27, 2012
Sponsor
Chonbuk National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01472822
Brief Title
Efficacy of Omija (Schisandra Chinensis) Extract in Subjects With Knee Osteoarthritis
Official Title
Efficacy and Safety of Omija Extract on Gonarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chonbuk National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Knee Osteoarthritis
Keywords
Omija, knee osteoarthritis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Omija extract.
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Omija extract.
Intervention Description
Omija extract 1.2g/day for 12weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo 1.2g/day for 12weeks
Primary Outcome Measure Information:
Title
Changes in WOMAC (Western Ontario and McMaster University Osteoarthritis Index) Totol Score
Description
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).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Changes in Lysholm Index Score
Description
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).
Time Frame
12 weeks
Title
Changes in Hs-CRP(High Sensitivity C-reactive Protein)
Description
hs-CRP(high sensitivity C-reactive protein) was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame
12 weeks
Title
Changes in OSC(Osteocalcin)
Description
OSC(Osteocalcin) was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame
12 weeks
Title
Changes in DPD(Deoxypyridinoline)
Description
DPD(Deoxypyridinoline) was measured in study visit 1(0 week) and visit 3(12 week).
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong-Hwan Seo, MD
Organizational Affiliation
Chonbuk National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
City
Jeonju
State/Province
Jeollabuk-do
ZIP/Postal Code
560-822
Country
Korea, Republic of

12. IPD Sharing Statement

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

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