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This study investigates if Shinbaro capsule has a lower incident of gastrointestinal events than celecoxib in subjects with osteoarthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shinbaro | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shinbaro Capsule | Drug | 600mg twice a day (b.i.d) oral herbal medicine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with gastrointestinal adverse events | Baseline through 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| percentage of subjects with perforation, ulcer, bleeding | baseline throgh week 24 | |
| percentage of subjects who withdrew due to GI AEs | baseline through week 24 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| BG Lee | GC Biopharma Corp | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyungpook national university hospital | Daegu | Kyungpook | South Korea | |||
| BundangCha Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27196293 | Derived | Ha CW, Park YB, Kyung HS, Han CS, Bae KC, Lim HC, Park SE, Lee MC, Won YY, Lee DC, Cho SD, Kim CW, Kim JG, Kang JS, Lee JH, Choi ES, Seon JK, Lee WS, Bin SI. Gastrointestinal safety and efficacy of long-term GCSB-5 use in patients with osteoarthritis: A 24-week, multicenter study. J Ethnopharmacol. 2016 Aug 2;189:310-8. doi: 10.1016/j.jep.2016.05.031. Epub 2016 May 16. |
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| Frequency of AEs |
| baseline throgh week 24 |
| WOMAC change from baseline | 24 weeks |
| KKS (Korean Knee Score) change from baseline | 24 weeks |
| 100mm pain VAS on walking | 24 weeks |
| Bundang |
| South Korea |
| Inje University Busan Paik Hospital | Busan | South Korea |
| Chungbuk National University Hospital | Cheongju-si | South Korea |
| Keimyung University Dongsan Medical Center | Daegu | South Korea |
| Yeungnam University Hospital | Deagu | South Korea |
| Chonnam National University Hwasun Hospital | Hwasun | South Korea |
| Dongguk University Medical Center | Ilsan | South Korea |
| Inha University Hospital | Inchun | South Korea |
| Chonbul National University Hospital | Jeonju | South Korea |
| Samsung Medical Center | Seoul | 130-710 | South Korea |
| Asan medical Center | Seoul | South Korea |
| Gangnam Severance Hospital | Seoul | South Korea |
| Inje University Seoul Paik Hospital | Seoul | South Korea |
| KyungHee University Medical Center | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Ajou University Hospital | Suwon | South Korea |
| Ulsan University Hospital | Ulsan | South Korea |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C571726 | shinbaro |
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