Ondansetron for tinnitus
- Conditions
- Tinnitus.Tinnitus
- Registration Number
- IRCT201105185867N4
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 60
The inclusion criteria are:
1) Patients with at least 6 month of tinnitus
2) 18 to 65 year old patients
3) Patients with chief compliant of tinnitus
4) Patients with sensorineural or normal hearing
Exclusion criteria:
1) Patients with severe illnesses and end stage diseases including liver, kidney and heart impairments. Patients with severe psychosis, dementia, cancers and those who are pregnant or lactating.
2) Patients with excessive problems and ones with psychiatric problems needing psychiatrist visit or ones who had an important surgery recently.
3) Patients with pulsatile tinnitus
4) Patients with worsening of tinnitus with head and neck movements
5) Patients on tinnitus treatment (including sound therapy, complements, drug...) unless still have tinnitus and have been remained on fix dosage of drug for more than acceptable time of action (for medications about 4 weeks).
6) Patients with cerumen impaction (unless tinnitus remained after cerumen removal)
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Tinnitus loudness based on VAS. Timepoint: At the beginnig and after 4 week. Method of measurement: Quesionnaire with 0 to 10 score.;Tinnitus handicapp scale(THI). Timepoint: At the beginning and after 4 weeks. Method of measurement: Quesionnaire.;Tinnitus severity. Timepoint: At the beginnig and after 4 weeks. Method of measurement: Quesionnaire (Tinnitus severity index questionnaire).
- Secondary Outcome Measures
Name Time Method SDS. Timepoint: At the begining and after 4 weeks. Method of measurement: Audiometry.;Depression and anxiety. Timepoint: At the beginning and after 4 weeks. Method of measurement: HADS quesionnaire.;Side effect. Timepoint: At the beginnig and after 4 weeks. Method of measurement: Quesionnaire.;Tinnitus loudness match. Timepoint: At the beginnig and after 4 weeks. Method of measurement: Audiometry.;Tinnitus pich match. Timepoint: At the beginnig and after 4 weeks. Method of measurement: Audiometry.;PTA. Timepoint: At the beginnig and after 4 weeks. Method of measurement: Audiometry.;SRT. Timepoint: At the begining and after 4 weeks. Method of measurement: Audiomtry.