Efficacy of Donepezil in Patients With Chronic Tinnitus
Not Applicable
Active, not recruiting
- Conditions
- Tinnitus
- Interventions
- Drug: Donepezil groupDrug: Placebo group
- Registration Number
- NCT07153991
- Lead Sponsor
- University of Sao Paulo
- Brief Summary
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.
- Detailed Description
Treatment effects were monitored using the Tinnitus Handicap Inventory (THI) and the Visual Analogue Scale (VAS).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
- patients with chronic sensorineural tinnitus type
Exclusion Criteria
- pregnancy, arrhythmia, donepezil allergy, yelow dye allergy, otitis or any ear inflamatory diseases, patients taking any medication for dementia, convulsive diseases, asthma, patients taking any of these medications: carbamazepine, dexamethasone, phenobarbital, phenytoin, rifampicin, ketoconazole, quinidine.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Group (donepezil) Donepezil group 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. Placebo group Placebo group 35 Pacients with tinnitus received for 3 months placebo medication
- Primary Outcome Measures
Name Time Method tinnitus improvement 3 months Treatment effects were monitored using the Tinnitus Handicap Inventory (THI) and the Visual Analogue Scale (VAS).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Universidade De São Paulo
🇧🇷São Paulo, São Paulo, Brazil
Universidade De São Paulo🇧🇷São Paulo, São Paulo, Brazil