tinnitus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Outpatients aged 20 to 80 at the time of consent, regardless of gender 2) The first onset chronic, persistent, and subjective unilateral tinnitus whose duration is 2-18 months. 3) Unilateral or bilateral sensorineural hearing loss, with a hearing loss no less than 30 dB at 4,000 Hz or at 8,000 Hz 4) THI-12 total score no less than 9 and TRSw total score no less than 12 5) HADS depression score no more than 14 and HADS anxiety score no more than 14
Exclusion criteria
Exclusion criteria: a. Person with past or current malignant tumor b. Person with severe comorbidities, such as heart, liver, kidney, blood, or mental diseases c. Person with allergy against medicine or the test food d. Pregnant, unwilling to practice contraception during the study, or lactating female e. Person with middle ear disease f. Person with a history of fluctuating hearing loss, ear fullness, or recurrent dizziness g. Person with conductive hearing loss or mixed hearing loss h. Person who have been treated for sudden deafness or acute sensorineural hearing loss within the past six months i. Person who have taken prohibited drugs or treatments within 4 months prior to the start of the study, or person who have changed the dosage of drugs that are prohibited from being changed during the study period within 4 months prior to the start of the study j. Person who is not judged as not qualified by the general administrator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TRSw | — |
Secondary
| Measure | Time frame |
|---|---|
| TRSd, THI-12, HADS, Hearing test thresholds, safety (frequency of adverse events) | — |
Contacts
University of Toyama