NCT01472822

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 17, 2011

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

February 4, 2013

Completed
Last Updated

February 4, 2013

Status Verified

December 1, 2012

Enrollment Period

3 months

First QC Date

November 14, 2011

Results QC Date

July 26, 2012

Last Update Submit

December 27, 2012

Conditions

Mild Knee Osteoarthritis

Keywords

Omijaknee osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Changes in Lysholm Index Score

    12 weeks

  • Changes in Hs-CRP(High Sensitivity C-reactive Protein)

    12 weeks

  • Changes in OSC(Osteocalcin)

    12 weeks

  • Changes in DPD(Deoxypyridinoline)

    12 weeks

Study Arms (2)

Omija extract.

EXPERIMENTAL
Dietary Supplement: Omija extract.

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

Omija extract.DIETARY_SUPPLEMENT

Omija extract 1.2g/day for 12weeks

Omija extract.
PlaceboDIETARY_SUPPLEMENT

Placebo 1.2g/day for 12weeks

Placebo

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 560-822, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Results Point of Contact

Title
Dr. Jeong-Hwan Seo, MD
Organization
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
vivaseo@jbnu.ac.kr
82-63-276-8284

Study Officials

  • Jeong-Hwan Seo, MD

    Chonbuk National University Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Trial Center for Functional Foods

Study Record Dates

First Submitted

November 14, 2011

First Posted

November 17, 2011

Study Start

March 1, 2011

Primary Completion

June 1, 2011

Study Completion

December 1, 2011

Last Updated

February 4, 2013

Results First Posted

February 4, 2013

Record last verified: 2012-12

Locations

KR(1)