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| Name | Class |
|---|---|
| Nutribiotech Co., Ltd. | INDUSTRY |
| Neonutra | INDUSTRY |
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This study is a 12-week, multicenter, randomized, double-blind, placebo-controlled clinical trial in order to evaluate the efficacy and safety of tabetri on osteoarthritis.
This study is prospectively conducted to investigate the efficacy and safety of tabetri in patients diagnosed with osteoarthritis at 4 locations of Jaseng Hospital of Korean Medicine (Gangnam, Haeundae, Daejeon, and Bucheon).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tabetri | Experimental | Tabetri capsule will be administered orally twice daily for 12 weeks |
|
| Placebo | Placebo Comparator | Placebo capsule will be administered orally twice daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tabetri capsule | Dietary Supplement | 1,000 mg/capsule (Taheebo extract 600 mg/day) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| VAS (Visual Analogue Scale) | VAS is used to measure changes in joint pain on 6 and 12 weeks after administration in comparison with baseline. It is presented as a 100-mm horizontal line on which the patient's pain intensity is presented by a point between the extremes of "no pain at all" and "worst pain imaginable." | Change of the week 6 and 12 from baseline |
| K-WOMAC (Korean-Western Ontario and McMaster Universities) | K-WOMAC is used to measure changes in joint pain and function on 0, 6, and 12 weeks after administration in comparison with baseline. It measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). | Change of the week 6 and 12 from baseline |
| KSF-36 (Korean-Short Form Health Survey 36) | KSF-36 is used to measure changes in physical and mental function on 0, 6, and 12 weeks after administration in comparison with baseline. It is a 36-item self-report measure designed to assess health-related functioning. It contains eight subscales with four pertaining to physical functioning and four pertaining to psychological functioning. Scores on each subscale can range from 0 to 100, with a higher score representing better health-related functioning. Two composite scores are calculated by averaging all of the scores for four subscales pertaining to each of the two general aspects of functioning. | Change of the week 6 and 12 from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Subject's global impression of change scale | The change in activity limitations, symptoms, emotions and overall quality of life, related to painful condition that is assessed by subject Level of Quality
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| In-Hyuk Ha, KMD, MPH | Jaseng Medical Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bucheon Jaseng Hospital of Korean Medicine | Bucheon-si | Gyeonggi-do | South Korea | |||
| Haeundae Jaseng Hospital of Korean Medicine |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Placebo capsule |
| Dietary Supplement |
1,000 mg/capsule |
|
| 6 and 12 weeks |
| Investigator's global impression of change scale | The change in activity limitations, symptoms, emotions and overall quality of life, related to painful condition that is assessed by investigator Level of Quality
| 6 and 12 weeks |
| ESR (Erythrocyte sedimentation rate) | ESR to measure changes in blood inflammatory marker on 12 weeks after administration in comparison with baseline | Change of the week 12 from baseline |
| CRP (C-reactive protein) | CRP to measure changes in blood inflammatory marker on 12 weeks after administration in comparison with baseline | Change of the week 12 from baseline |
| Busan |
| South Korea |
| Daejeon Jaseng Hospital of Korean Medicine | Daejeon | South Korea |
| Jaseng Hospital of Korean Medicine | Seoul | South Korea |