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IRCT20200127046283N1 IRCT 2020-06-10 Zahedan University of Medical Sciences The efficacy of gabapentin on tinnitus Comparison of the efficacy of gabapentin with placebo on Idiopathic tinnitus 2020-06-22 anticipated 56 Complete https://irct.ir/trial/45418 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Method of randomization: simple Unit of randomization: individual Tools used in randomization: table of random numbers. patient assignment in groups A and B will be done based on a completely randomized design. To prevent bias in our study a double-blind design will be performed. Both analgesics are in separate boxes A and B, and only the ENT specialist is aware of the drug's content in each group, Blinding description: Patients will be treated with prescribed medication packages by an ENT specialist. Drug packages are quite similar in shape, and the patient and project manager are unaware of the contents of the packages. Data gathering, patient analysis and filling the forms will be done by investigator and the assistant who are not aware of the contents of the packages; In the data analysis step, the analysis will be done by the project advisor and the investigator, who are not aware of the contents of the drug packages, and groups of patients (groups 1 or 2) will be defined for the data analysis. Therefore, the study is a double blind study and from the stage of the patient's entry into the study to the study phase, data collection and data analysis, the contents of the two drug groups are not clear. 3 Idiopathic tinnitus. Intervention 1: Intervention group: The treated individuals included all patients with idiopathic tinnitus referred to the ETN Clinic of Al-Zahra Hospital in 1998-99, for 12 weeks after the intervention with gabapentin (300 mg daily, made by Razak Company, Tehran, Iran). They are followed up on a monthly basis. The group will be treated for 12 weeks. Intervention 2: Control group: Control individuals included all patients with idiopathic tinnitus referred to the ETN Clinic of Al-Zahra Hospital in 1998-99, which were followed up monthly for 12 weeks after the intervention with placebo. The group will also be reviewed for 12 weeks. Yes - There is a plan to make this available What will be shared: All un-deidentified data will be shared once collecting. When: Starting one year after publication To whom: The outcome will be shared with academic institutes or people working in businesses Conditions: Research Ethics Committee Where to obtain: Raw data rashidi-darya@gmail.com How to obtain: Writing a request via email Comments:
public Mohsen Rashidi ravari
Motahari Blvd; before Khatam square; Zahedan Town
Zahedan Iran (Islamic Republic of) 9816737789 +98 54 3321 4157 rashidi.sd@gmail.com Zahedan University of Medical Sciences scientific Zahra Ghiasi
Imam Khomeini Ave; In front of Ghale office; Baharan hospital
Zahedan Iran (Islamic Republic of) 9819713955 +98 54 3351 3779 linooshghiasi@gmail.com Zahedan University of Medical Sciences Iran (Islamic Republic of) All the patient with idiopathic tinnitus referred to the ENT clinic of the Al-Zahra hospital Age between 18 and 65 Satisfaction to enter this study Patient assistance to use the drug No pregnancy , lactescent, or plan to pregnancy in the next 6 months Normal audiometry test 18 years 65 years Both Use narcotic or alcohol or sedative drugs in the past 48 hours Use MAOI, SSRI, TCA ,phenothiazine, soporific drugs in the past Sensitivity to gabapentine No satisfaction with being a case study in this study No assistance to use the drug Patient with pulsative tinnitus Patient with acute / choronic internal or middle ear infection Patient with thyroid disease Patient with rheumatologic disease Deals with noisy workplace Age more than 65 years Simultaneous use of other drugs except for gabapentin H93.1 Tinnitus Treatment - Drugs Placebo Intervention group: The treated individuals included all patients with idiopathic tinnitus referred to the ETN Clinic of Al-Zahra Hospital in 1998-99, for 12 weeks after the intervention with gabapentin (300 mg daily, made by Razak Company, Tehran, Iran). They are followed up on a monthly basis. The group will be treated for 12 weeks. Control group: Control individuals included all patients with idiopathic tinnitus referred to the ETN Clinic of Al-Zahra Hospital in 1998-99, which were followed up monthly for 12 weeks after the intervention with placebo. The group will also be reviewed for 12 weeks. The score of tinnitus in tinnitus severity index questionnaire and visual analogue scale. Timepoint: The amount of tinnitus at the beginning of the study and 1, 2 and 3 months after starting the drug and placebo will be measured. Method of measurement: Tinnitus severity index questionnaire, visual analogue scale and 5 point scale for satisfaction. Side effects of prescribed drug. Timepoint: 1-2-3 months after using drug. Method of measurement: ask about vertigo، nasea، drowsiness، biurred vision ،fatigue. Zahedan University of Medical Sciences Approved 2020-01-05 Ethics committee of zahedan university of medical sciences Alzahra Hospital; Motahari Blvd; Zahedan Town Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)