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

Chonbuk National University

Status and phase

Completed

Phase 3

Phase 2

Conditions

Mild Knee Osteoarthritis

Treatments

Dietary Supplement: Placebo

Dietary Supplement: Omija extract.

Study type

Interventional

Funder types

Other

Identifiers

NCT01472822

BIOYD-KA-SCHISANDRA

Details and patient eligibility

About

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.

Full 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).

Enrollment

60 patients

Sex

All

Ages

30 to 70 years old

Volunteers

Accepts 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)