Efficacy of Donepezil in Patients With Chronic Tinnitus
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- tinnitus improvement
研究概览
简要总结
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.
详细描述
Treatment effects were monitored using the Tinnitus Handicap Inventory (THI) and the Visual Analogue Scale (VAS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with chronic sensorineural tinnitus type
排除标准
- •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.
研究组 & 干预措施
Intervention Group (donepezil)
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.
干预措施: Donepezil group (Drug)
Placebo group
35 Pacients with tinnitus received for 3 months placebo medication
干预措施: Placebo group (Drug)
结局指标
主要结局
tinnitus improvement
时间窗: 3 months
Treatment effects were monitored using the Tinnitus Handicap Inventory (THI) and the Visual Analogue Scale (VAS).
次要结局
未报告次要终点
研究者
Elaine Miwa Watanabe
medical doctor
University of Sao Paulo