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

Efficacy and Safety of Omija Extract on Gonarthritis

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01472822

Enrollment

Registered

2011-11-17

Start date

2011-03-31

Completion date

2011-12-31

Last updated

2013-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Knee Osteoarthritis

Keywords

Omija, knee osteoarthritis

Brief 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).

Interventions

DIETARY_SUPPLEMENTOmija extract.

Omija extract 1.2g/day for 12weeks

DIETARY_SUPPLEMENTPlacebo

Placebo 1.2g/day for 12weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

30 Years to 70 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
Changes in WOMAC (Western Ontario and McMaster University Osteoarthritis Index) Totol Score	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).

Secondary

Measure	Time frame	Description
Changes in Lysholm Index Score	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)	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)	12 weeks	OSC(Osteocalcin) was measured in study visit 1(0 week) and visit 3(12 week).
Changes in DPD(Deoxypyridinoline)	12 weeks	DPD(Deoxypyridinoline) was measured in study visit 1(0 week) and visit 3(12 week).

Countries

South Korea

Participant flow

Recruitment details

Participants were recruited through local advertising and doctor referrals from hospital outpatients and general practice clinics.

Pre-assignment details

The criteria were an age from 30 to 70 years, mild to Moderate KO as indicated by WOMAC(Western Ontario and McMaster Universities Arthritis Index) score ≥ 38 subjects.

Participants by arm

Arm	Count
Omija	30
Placebo	30
Total	60

Baseline characteristics

Characteristic	Placebo	Omija	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	30 Participants	30 Participants	60 Participants
Age Continuous	52.4 years STANDARD_DEVIATION 9.6	52.1 years STANDARD_DEVIATION 9.5	52.2 years STANDARD_DEVIATION 9.5
Region of Enrollment Korea, Republic of	30 participants	30 participants	60 participants
Sex: Female, Male Female	28 Participants	27 Participants	55 Participants
Sex: Female, Male Male	2 Participants	3 Participants	5 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 30	0 / 30
serious Total, serious adverse events	0 / 30	0 / 30

Outcome results

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).

Time frame: 12 weeks