The Effect of Riluzole on Tinnitus in Patients Referring to Amir Alam Hospital during 2017-18: A randomized, placebo-controlled clinical trial

Investigation of the effect of Riluzole on tinnitus severity

This project is a double-blind randomized controlled clinical trial which is conducted in 2017-18. The study population consisted of all patients aged 18-70 years old, with the chief complaint of tinnitus for more than 3 months who referred to the Tinnitus Clinic of Amiralam Hospital. A total of 48 patients are randomly divided into two equal groups of placebo and main drug group. Randomization will be done by using the four block size.

Patients referred to Tinnitus Clinic of Amiralam Hospital who are eligible for this study are randomly divided into two groups of main drug and placebo .The main drug group will be received the 50 mg Rilozole oral tablet twice a day for three months and the placebo group received a similar drug as a placebo .The tinnitus insensitivity will be assessed with THI questionnaire on the first day and 90th day of the study. Also, in terms of drug side effects, tinnitus pitch match ,tinnitus loudness match and maskability are also checked in the same way . The patients and the main investigators who measure the initial outcome are blind to The type of medication .

Patients aged 18- 70 years who referred to the Tinnitus Clinic with chief complaint of Tinnitus more than three months are included in the study. Those who had middle and external ear disease; conductive and mixed hearing loss; the presence of the Pulsatile tinnitus type; the presence of temporomandibular joint disorders; receiving medications with Systemic effects (in relation to tinnitus) over the past 6 months; tinnitus with less than three months; mild tinnitus with a THI of> 36 and liver and kidney failure will not be included in the study.

Intervention includes the administration of oral tablets of Riluzole in one group and the administration of placebo tablets in the control group.

The severity of tinnitus was measured by using the THI questionnaire and auditory evaluation using the PTA test.

Randomization will be done by 4 block size.

Since the placebo is exactly the same as the original medicine, and when informed consent is informed, the patient is randomly assigned to one of the drug or placebo groups, so the patient is not aware of the type of medication. Also, the main investigator who examined the initial outcome will be blind to patient's drug type, because the allocation is done by another researcher.