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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1248-6988 | Registry Identifier | UTN Universal Trial Number |
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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
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This study is a prospective, placebo-controlled, randomized, double-blind clinical trial, including 70 patients with chronic sensorineural tinnitus, divided into placebo and treatment groups. Participants received donepezil for 3 months, starting with 5 mg daily for the first month and 10 mg daily for the following two months.
Treatment effects were monitored using the Tinnitus Handicap Inventory (THI) and the Visual Analogue Scale (VAS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group (donepezil) | Experimental | 35 Participants with tinnitus received donepezil for 3 months, starting with 5 mg daily for the first month and 10 mg daily for the following two months. |
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| Placebo group | Placebo Comparator | 35 Pacients with tinnitus received for 3 months placebo medication |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Donepezil group | Drug | Participants received donepezil for 3 months, starting with 5 mg daily for the first month and 10 mg daily for the following two months |
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| Measure | Description | Time Frame |
|---|---|---|
| tinnitus improvement | Treatment effects were monitored using the Tinnitus Handicap Inventory (THI) and the Visual Analogue Scale (VAS). | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade De São Paulo | São Paulo | São Paulo | 04356080 | Brazil |
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| ID | Term |
|---|---|
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| Placebo group | Drug | 35 Pacients with tinnitus received for 3 months placebo medication |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |