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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omija extract. | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omija extract. | Dietary Supplement | Omija extract 1.2g/day for 12weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeong-Hwan Seo, MD | Chonbuk National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Center for Functional Foods; Chonbuk National University Hospital | Jeonju | Jeollabuk-do | 560-822 | South Korea |
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 were recruited through local advertising and doctor referrals from hospital outpatients and general practice clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | Omija Extract. | Omija extract.(2times/day, 4tablets/day, 1.2g/day) for 12weeks Omija extract.: Omija extracted with ethanol and then concentrated and dried. |
| FG001 | Placebo | Placebo(2times/day, 4tablets/day, 1.2g/day) for 12weeks Placebo : Amount and calorie of placebo are same with Omija extract.. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Omija | |
| BG001 | Placebo | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | per protocol analysis | Posted | Mean | Standard Deviation | Score | 12 weeks |
|
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Serious and/or other [non-serious] adverse events were not collected/assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Omija | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeong-Hwan Seo, MD | Clinical Trial Center for Functional Foods; Chonbuk National University Hospital | 82-63-276-8284 | vivaseo@jbnu.ac.kr |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Placebo |
| Dietary Supplement |
Placebo 1.2g/day for 12weeks |
|
| 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 |
| Changes in OSC(Osteocalcin) | OSC(Osteocalcin) was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks |
| Changes in DPD(Deoxypyridinoline) | DPD(Deoxypyridinoline) was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks |
Total of all reporting groups
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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). | per protocol analysis | Posted | Mean | Standard Deviation | units on a scale(0-100) | 12 weeks |
|
|
|
| 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). | per protocol analysis | Posted | Mean | Standard Deviation | mg/L | 12 weeks |
|
|
|
| Secondary | Changes in OSC(Osteocalcin) | OSC(Osteocalcin) was measured in study visit 1(0 week) and visit 3(12 week). | per protocol analysis | Posted | Mean | Standard Deviation | ng/ml | 12 weeks |
|
|
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| Secondary | Changes in DPD(Deoxypyridinoline) | DPD(Deoxypyridinoline) was measured in study visit 1(0 week) and visit 3(12 week). | per protocol analysis | Posted | Mean | Standard Deviation | nanoMolar DPD per milliMolar creatine | 12 weeks |
|
|
|
| 30 |
| 0 |
| 30 |
| EG001 | Placebo | 0 | 30 | 0 | 30 |
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| D012216 |
| Rheumatic Diseases |