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| Name | Class |
|---|---|
| Kyung Hee University Hospital at Gangdong | OTHER |
| Hamsoa Pharmaceutical Co., Ltd. | INDUSTRY |
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This trial is a multi-center, randomized, double-blind, placebo-controlled, parallel, phase II clinical trial and aimed at osteoarthritis of the knee.
Patients who signed informed consent voluntarily and eligible for this study are assigned randomly to one of 3 groups after 2 week-Washout period.
Patients will take WIN-34B or Placebo BID for 12 weeks. Based on baseline, after 4 weeks(Visit 3) and 12 weeks(Visit 5), Researchers check patients' physical examination, questionnaire, laboratory experiment.
After 8 weeks(Visit 4), researchers check adverse effects and current medication status via telephone interview.
After 12 weeks(Visit 5) patients stop taking drugs and after 16 weeks(Visit 6) researchers check patients' physical examination, questionnaire, adverse effects and current medication status.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1st group : WIN-34B 900mg | Experimental | Patients assigned to 1st group take WIN-34B 450mg BID for 12weeks |
|
| 2nd group : WIN-34B 1800mg | Experimental | Patients assigned to 2nd group take WIN-34B 900mg BID for 12weeks |
|
| 3rd group : Placebo | Placebo Comparator | Patients assigned to 3rd group take Placebo BID for 12weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WIN-34B | Drug | Patients assigned to Experimental group(1st or 2nd group) take WIN-34B 450mg or WIN-34B 900mg BID for 12weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| KWOMAC(Korean Western Ontario and McMaster Universities Osteoarthritis Index) | Changes from baseline at 4, 12, 16weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pain VAS 100mm | Visit1(screening), Visit2(0week), Visit3(4weeks), Visit4(8weeks), Visit5(12weeks), Visit6(16weeks) | |
| KHAQ(Korean Health Assessment Questionnaire) | Visit2(0week), Visit3(4weeks), Visit5(12weeks), Visit6(16weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dong-Suk Park | Kyung Hee University Hospital at Gangdong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyung Hee University Oriental Medicine Hospital at Gangdong | Seoul | 134-727 | South Korea |
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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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| ID | Term |
|---|---|
| C569023 | WIN 34B |
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| Placebo | Drug |
|
| LFI(Lequesne's Functional Index) | Visit2(0week), Visit3(4weeks), Visit5(12weeks), Visit6(16weeks) |
| Nine Point Scale | Visit5(12weeks) |
| Cold-Heat Questionnaire | Visit2(0week), Visit3(4weeks), Visit5(12weeks), Visit6(16weeks) |
| Dose and Frequency of Rescue drug | Visit2(0week), Visit3(4weeks), Visit4(8weeks), Visit5(12weeks), Visit6(16weeks) |
| Safety(Vital sign, Physical examination, Laboratory experiment, ECG, Adverse event) | Visit1(screening), Visit2(0week), Visit3(4weeks), Visit4(8weeks), Visit5(12weeks), Visit6(16weeks) - There are some differences in subgroup at every visit |
| D012216 |
| Rheumatic Diseases |