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| ID | Type | Description | Link |
|---|---|---|---|
| 20130055275 | Other Identifier | KFDA |
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Participant enrollment is much delayed. The whole design needs to be revised.
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| Name | Class |
|---|---|
| SK Chemicals Co., Ltd. | INDUSTRY |
| Asan Medical Center | OTHER |
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The purpose of this study is to determine whether Renexin is effective in the treatment of vestibular symptoms in patients with recurrent vestibulopathy.
Study design
Statistical analysis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renexin | Active Comparator | Renexin 1T bid for 12 weeks |
|
| Placebo | Placebo Comparator | Placebo 1T bid for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renexin (cilostazol 100mg + gingko biloba extract 80 mg) | Drug | Take Renexin 1T bid po medication for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| equilibrium score of dynamic posturography | compared with pretreatment equilibrium score | after 8 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| dizziness handicap inventory | compared with pretreatment DHI score | at 4 weeks, 8 weeks after treatment |
| visual analogue scale (VAS) of vertigo | compared with pretreatment VAS score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jong Woo Chung, MD | Asan Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | 138-736 | South Korea |
This study is decided to be terminated. Among 26 participants, 15 finished medication according to the protocol. I am not sure that these data can be analyzed because data is still unblinded.
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| ID | Term |
|---|---|
| D020338 | Vestibular Neuronitis |
| ID | Term |
|---|---|
| D000160 | Vestibulocochlear Nerve Diseases |
| D012181 | Retrocochlear Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| C000593066 | renexin |
| D000077407 | Cilostazol |
| D000096983 | Ginkgo Extract |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Take placebo drug 1T bid po medication for 8 weeks |
|
|
| at 4 weeks, 8 weeks after treatment |
| Questionnaire for Quality of life (SF36) | compared with pretreatment SF36 score | at 4 weeks, 8 weeks after treatment |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010936 | Plant Extracts |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |