Efficacy of Omija (Schisandra Chinensis) Extract in Subjects With Knee Osteoarthritis
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|ClinicalTrials.gov Identifier: NCT01472822|
Recruitment Status : Completed
First Posted : November 17, 2011
Results First Posted : February 4, 2013
Last Update Posted : February 4, 2013
|Condition or disease||Intervention/treatment||Phase|
|Mild Knee Osteoarthritis||Dietary Supplement: Omija extract. Dietary Supplement: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Efficacy and Safety of Omija Extract on Gonarthritis|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||December 2011|
|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
- Changes in WOMAC (Western Ontario and McMaster University Osteoarthritis Index) Totol Score [ Time Frame: 12 weeks ]
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).
- Changes in Lysholm Index Score [ Time Frame: 12 weeks ]
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 ]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 ]OSC(Osteocalcin) was measured in study visit 1(0 week) and visit 3(12 week).
- Changes in DPD(Deoxypyridinoline) [ Time Frame: 12 weeks ]DPD(Deoxypyridinoline) was measured in study visit 1(0 week) and visit 3(12 week).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01472822
|Korea, Republic of|
|Clinical Trial Center for Functional Foods; Chonbuk National University Hospital|
|Jeonju, Jeollabuk-do, Korea, Republic of, 560-822|
|Principal Investigator:||Jeong-Hwan Seo, MD||Chonbuk National University Hospital|