Tinnitus. Tinnitus
Conditions
Interventions
Intervention 1: Ondansetron 16mg
for one month (4 tablets a day). Intervention 2: Placebo (4 tablet a day) for one month.
Treatment - Drugs
Placebo
Ondansetron 16mg
for one month (4 tablets a day)
Placebo (4 tablet a day) for one month
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactShervin Taslimi
Tehran University of Medical Sciences
Outcome results
None listed