]>
IRCT201105185867N4 IRCT 2011-07-16 Tehran University of Medical Sciences Ondansetron for tinnitus Evaluation of ondansetron in patients with tinnitus: double blind control clinical trial 2011-05-18 anticipated 60 Complete https://irct.ir/trial/6355 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 2 Tinnitus. Intervention 1: Ondansetron 16mg for one month (4 tablets a day). Intervention 2: Placebo (4 tablet a day) for one month.
public Shervin Taslimi
ENT ward,Amiralam hospital, sadi street, Tehran
Tehran Iran (Islamic Republic of) +98 912 387 0602 taslimi@razi.tums.ac.ir Tehran University of Medical Sciences scientific Shervin Taslimi
ENT ward,Amiralam hospital, sadi street, Tehran
Tehran Iran (Islamic Republic of) +98 912 387 0602 taslimi@razi.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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) 18 years 65 years Both H93.1 Tinnitus Treatment - Drugs Placebo Ondansetron 16mg for one month (4 tablets a day) Placebo (4 tablet a day) for one month 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). 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. Tehran University of Medical Sciences Approved 2010-06-26 Tehran University of Medical Sciences Ethics committee Tehran University of Medical Sciences central building, Qods street, Keshavarz Blv. Tehran Iran (Islamic Republic of)