determine the efficacy Single and Combination Medication Treatment of Tinnitus by Alprazolam and Fluoxetine
Design
In this research, 147 patients with tinnitus referring to Amiralmomenin hospital were chosen purposefully and a code was allocated to each one of them.Then, patients were randomly divided into two control and intervention groups.
Settings and conduct
patients with chronic, non-pulsatile tinnitus (taking more than six months) will be participated in the study. An informed consent of the patients participating in the study will be obtained after giving a detailed explanation about the study. For all participants, audiometric testing will be requested before treatment and again a week after four weeks of treatment. Patients will be informed to refer to the study’s designated physician in the hospital in case of fever, sore throat, rash, unusual bruising and bleeding. Patients will randomly be divided into four groups based on a random table:
Group 1: Fluoxetine
Group 2: Alprazolam + Fluoxetine
Group 3: Placebo
Participants/Inclusion and exclusion criteria
Patients with 20-65 years of age; Tinnitus history taking at least six months; Exclusion Criteria: Acute or chronic middle ear infections; History of thyroid and rheumatologic diseases; History of occupational exposure to noise; Concomitant use of other drugs;
Intervention groups
Group 1: Fluoxetine
Group 2: Alprazolam + Fluoxetine
Group 3: Placebo
Main outcome variables
Tinnitus
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080831001138N26
Registration date:2018-02-17, 1396/11/28
Registration timing:registered_while_recruiting
Last update:2018-02-17, 1396/11/28
Update count:0
Registration date
2018-02-17, 1396/11/28
Registrant information
Name
Fataneh Bakhshi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1223 8307
Email address
entrc@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Science, Vice Chancellor for Resarch
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of Single and Combination Medication Treatment of Tinnitus by Alprazolam and Fluoxetine
Public title
Tinnitus treatment with single or combination medication
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with 20-65 years of age
Tinnitus history taking at least six months
Exclusion criteria:
Acute or chronic middle ear infections
History of thyroid and rheumatologic diseases
History of occupational exposure to noise
Concomitant use of other drugs
Age
From 20 years old to 65 years old
Gender
Both
Phase
4
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
147
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
vice-chancellor for Research Building, opposite of Sepah Bank,Shahid Beheshti Blvd
City
Raht
Province
Guilan
Postal code
4139637459
Approval date
2017-07-29, 1396/05/07
Ethics committee reference number
IR.GUMS.REC.1395.185
Health conditions studied
1
Description of health condition studied
Tinnitus
ICD-10 code
H93.1
ICD-10 code description
Tinnitus
Primary outcomes
1
Description
Tinnitus
Timepoint
Starting Time, Fifth week
Method of measurement
TSI Questionnaire and VAS Score
Secondary outcomes
1
Description
Anxiety
Timepoint
Starting Time(time0), Fifth Week
Method of measurement
Beck Anxiety Inventory (BAI)
2
Description
Depression
Timepoint
Starting Time(time0), Fifth Week
Method of measurement
Beck Depression Inventory
Intervention groups
1
Description
Alprazolam: Daily taking of 0.5 mg till the end of the fourth week of treatment
Category
Treatment - Drugs
2
Description
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.
Category
Treatment - Drugs
3
Description
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.