(1) Objective: Determination of fluvoxamine effect on tone, frequency and intensity of tinnitus due to sensorineural hearing loss in referred patients to Khorramabad Shohadaye Ashayer Hospital. (2) Design: Randomized / Triple blind / Controlled with Placebo / Single center. (3) Method: Sampling method is based on inclusion criteria. One hundred patients will be randomly divided into two groups of fifty patient, A and B. In group A, fluvoxamine (50 mg daily) and in group B, placebo will be given for one month. Characteristics of tinnitus include frequency, intensity and tone, will be evaluated by tinnitus matching, before and after treatment. Result will be compared at the end of the study. (4) Participants, Inclusion and exclusion criteria: Sample volume is 100. Inclusion criteria: The patients who suffer from sensorineural hearing loss and tinnitus / No contraindication to fluvoxamine / With a written consent form. Exclusion criteria: Using similar drugs / Using other medications that interact with fluvoxamine / Fluvoxamine side effects presentation. (5) Interventions: Fluvoxamine and placebo (capsules consisted of corn starch) will be given to patients for one month. (6) Primary outcome measure: Intensity of tinnitus according to tinnitus matching
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012101811157N1
Registration date:2012-11-25, 1391/09/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-11-25, 1391/09/05
Registrant information
Name
Fateme Beiranvand
Name of organization / entity
Lorestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 6616200155169
Email address
drkazemi@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Lorestan University of Medical Sciences, Vice chancellor for research
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2012-11-21, 1391/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The clinical trial of comparing the effect of fluvoxamine with placebo on intensity of tinnitus due to sensorineural hearing loss
Public title
Evaluation of fluvoxamine
effect on tinnitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The patients who suffer from sensorineural hearing loss and tinnitus / No contraindication to fluvoxamine /With a written consent form
Exclusion criteria: Using similar drugs / Using other medications that interact with fluvoxamine / Fluvoxamine side effects presentation
Age
From 20 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
This study is triple blind because: (1) Researcher and statistician
do not know which one of two drugs the patient has received. (2) The patient does not know which one of two drugs has received. (3) The clinic receptionist gives drugs to patients in pockets marked with A and B.
Randomization method: The patients will be matched by stratified block method according to intensity of tinnitus, sex and age groups, and also will be randomly allocated into tow groups, A and B.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Lorestan University of Medical Sciences
Street address
Pardis (Kamalvand) Academic Centre, Fifth kilometer of Khorramabad- Brujerd road
City
Khorramabad
Postal code
Approval date
2012-09-22, 1391/07/01
Ethics committee reference number
200/73/740
Health conditions studied
1
Description of health condition studied
Tinnitus
ICD-10 code
H93.1
ICD-10 code description
Tinnitus
Primary outcomes
1
Description
Intensity of tinnitus
Timepoint
Before and one month after intervention
Method of measurement
According to Tinnitus Matching
Secondary outcomes
1
Description
Frequency of tinnitus
Timepoint
Before and one month after intervention
Method of measurement
According to Tinnitus Matching
2
Description
Sex
Timepoint
Before intervention
Method of measurement
According to questionnaire
3
Description
Tone of tinnitus
Timepoint
Before and one month after intervention
Method of measurement
According to Tinnitus Matching
4
Description
Age
Timepoint
Before intervention
Method of measurement
According to questionnaire
5
Description
The satisfaction of treatment
Timepoint
After intervention
Method of measurement
According to Visual Analog Scale
Intervention groups
1
Description
Intervention/ Control1: Fluvoxamine group: Fluvoxamine / Oral Tablet 50 mg / Once a day for one month / Sobhan Company
Category
Treatment - Drugs
2
Description
Intervention/Control2: Control group: Placebo capsule consisted of corn starch / 250 mg / Oral / Once a day for one month
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Khorramabad Shohadaye Ashayer Hospital
Full name of responsible person
Dr. Siroos Kazemi, Otolaryngologist, Assistant Professor
Street address
Shohadaye Ashayer Hospital, Enghelab Street
City
Khorramabad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Lorestan University of Medical Sciences, Vice chancellor for research
Full name of responsible person
Dr. Mohammad Hasan Kayedi
Street address
Pardis (Kamalvand) Academic Centre, Fifth kilometer of Khorramabad - Brujerd Road
City
Khorramabad
Grant name
124409
Grant code / Reference number
1193
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Lorestan University of Medical Sciences, Vice chancellor for research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Dr. Siroos Kazemi
Position
Otolaryngologist, Assistant Professor
Other areas of specialty/work
Street address
Pardis (Kamalvand) Academic Centre, Fifth kilometer of Khorramabad - Brujerd Road
City
Khorramabad
Postal code
Phone
+98 6616200155169
Fax
Email
Drkazemi@lums.ac.ir
Web page address
www.lums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Dr. Siroos Kazemi
Position
Otolaryngologist, Assistant Professor
Other areas of specialty/work
Street address
Pardis (Kamalvand) Academic Centre, Fifth kilometer of Khorramabad - Brujerd Road
City
Khorramabad
Postal code
Phone
+98 6616200155169
Fax
Email
Drkazemi@lums.ac.ir
Web page address
www.lums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Dr. Siroos Kazemi
Position
Otolaryngologist, Assistant Professor
Other areas of specialty/work
Street address
Pardis (Kamalvand) Academic Centre, Fifth kilometer of Khorramabad - Brujerd Road
City
Khorramabad
Postal code
Phone
+98 6616200155169
Fax
Email
Drkazemi@lums.ac.ir
Web page address
www.lums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)