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

Mild Knee Osteoarthritis Clinical Trial

Official title:

Efficacy and Safety of Omija Extract on Gonarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01472822
• Other study ID #: BIOYD-KA-SCHISANDRA
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 14, 2011
• Last updated: December 27, 2012
• Start date: March 2011
• Est. completion date: December 2011

Study information

• Verified date: December 2012
• Source: Chonbuk National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Mild Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Dietary Supplement:
• Omija extract.
Omija extract 1.2g/day for 12weeks
• Placebo
Placebo 1.2g/day for 12weeks

Locations

Country	Name	City	State
Korea, Republic of	Clinical Trial Center for Functional Foods; Chonbuk National University Hospital	Jeonju	Jeollabuk-do

Sponsors (1)

Lead Sponsor	Collaborator
Chonbuk National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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).	12 weeks	Yes
Secondary	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).	12 weeks	Yes
Secondary	Changes in OSC(Osteocalcin)	OSC(Osteocalcin) was measured in study visit 1(0 week) and visit 3(12 week).	12 weeks	Yes
Secondary	Changes in DPD(Deoxypyridinoline)	DPD(Deoxypyridinoline) was measured in study visit 1(0 week) and visit 3(12 week).	12 weeks	Yes