NCT01472822

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

Efficacy and Safety of Omija Extract on Gonarthritis

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Chonbuk National University Hospital · Academic / Other
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Accepted

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).

Conditions

• Mild Knee Osteoarthritis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Omija extract.	Omija extract 1.2g/day for 12weeks
DIETARY_SUPPLEMENT	Placebo	Placebo 1.2g/day for 12weeks

Timeline

• Start date: 2011-03-01
• Primary completion: 2011-06-01
• Completion: 2011-12-01
• First posted: 2011-11-17
• Last updated: 2013-02-04
• Results posted: 2013-02-04

Locations

1 site across 1 country: South Korea