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IRCT20080831001138N26 IRCT 2018-02-17 Rasht University of Medical Sciences Tinnitus treatment with single or combination medication Study of Single and Combination Medication Treatment of Tinnitus by Alprazolam and Fluoxetine 2017-12-22 anticipated 147 Complete https://irct.ir/trial/194 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: According to the study's inclusion, the patients with tinnitus are assigned to tree groups by random block method. Before the study, the permutations are designed manually. 24 sextuple blocks with different permutations and a triple block of ABP are placed in a sealed envelope. Then, the blocks will be randomly taken out of the envelope, when the patients refer gradually to reach the sample size of 147. The envelopes are put in another room (research center), and a third party notifies the members about it, Blinding description: In order to maintain double blindness in the study, both patients and all researchers will be unaware of the received drug.( A researcher will explain about the drug to the patients and record data, and another researcher will evaluate the patients). Drugs will look completely similar in shape, color and size. The patients will be divided into three groups according to the Random Number Table. 4 Tinnitus. Intervention 1: Alprazolam: Daily taking of 0.5 mg till the end of the fourth week of treatment. Intervention 2: Oxcarbazepine: In the first week, its initial nightly dose will be 300 mg. After the second week until the end of the fourth week, the treatment will be continued with daily dose of 600 mg. Intervention 3: Fluoxetine: In the first week, its initial daily dose will be 20 mg. After the second week until the end of the fourth week, the treatment will be continued with daily dose of 50 mg. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Dr Alia Saberi
Amiralamomenin Hospital, 17 shahrivar St
Rasht Iran (Islamic Republic of) 4139637459 +98 13 3322 5242 a_saberi@gums.ac.ir Rasht University of Medical Sciences scientific Dr Alia Saberi
Amiralamomenin Hospital, 17 shahrivar St
Rasht Iran (Islamic Republic of) 4139637459 +98 13 3322 5242 a_saberi@gums.ac.ir Rasht University of Medical Sciences Iran (Islamic Republic of) Patients with 20-65 years of age Tinnitus history taking at least six months 20 years 65 years Both Acute or chronic middle ear infections History of thyroid and rheumatologic diseases History of occupational exposure to noise Concomitant use of other drugs H93.1 Tinnitus Treatment - Drugs Treatment - Drugs Treatment - Drugs Alprazolam: Daily taking of 0.5 mg till the end of the fourth week of treatment Oxcarbazepine: In the first week, its initial nightly dose will be 300 mg. After the second week until the end of the fourth week, the treatment will be continued with daily dose of 600 mg. Fluoxetine: In the first week, its initial daily dose will be 20 mg. After the second week until the end of the fourth week, the treatment will be continued with daily dose of 50 mg. Tinnitus. Timepoint: Starting Time, Fifth week. Method of measurement: TSI Questionnaire and VAS Score. Anxiety. Timepoint: Starting Time(time0), Fifth Week. Method of measurement: Beck Anxiety Inventory (BAI). Depression. Timepoint: Starting Time(time0), Fifth Week. Method of measurement: Beck Depression Inventory. Rasht University of Medical Sciences Approved 2017-07-29 Ethics committee of Guilan University of Medical Sciences vice-chancellor for Research Building, opposite of Sepah Bank,Shahid Beheshti Blvd Raht Guilan Iran (Islamic Republic of)