Efficacy of Donepezil in Patients With Chronic Tinnitus

Phase 4Active Not RecruitingNCT07153991

University of Sao Paulo70 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Tinnitus

Interventions

Donepezil groupDRUG

Participants received donepezil for 3 months, starting with 5 mg daily for the first month and 10 mg daily for the following two months

Placebo groupDRUG

35 Pacients with tinnitus received for 3 months placebo medication

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Universidade De São Paulo

São Paulo, São Paulo, Brazil

Outcomes

Primary Outcomes

tinnitus improvement

Treatment effects were monitored using the Tinnitus Handicap Inventory (THI) and the Visual Analogue Scale (VAS).

Time frame: 3 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.