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

Chonbuk National University Hospital60 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Mild Knee Osteoarthritis

Interventions

Omija extract.DIETARY_SUPPLEMENT

Omija extract 1.2g/day for 12weeks

PlaceboDIETARY_SUPPLEMENT

Placebo 1.2g/day for 12weeks

Eligibility

Sex: ALLMin age: 30 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Outcomes

Primary Outcomes

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).

Time frame: 12 weeks

Secondary Outcomes

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).

Time frame: 12 weeks

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).

Time frame: 12 weeks

Changes in OSC(Osteocalcin)

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

Time frame: 12 weeks

Changes in DPD(Deoxypyridinoline)

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

Time frame: 12 weeks

Data from ClinicalTrials.gov

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