Aim: Evaluation the effect of sertraline and melatonin on the treatment of tinnitus. Design: In this Clinical trial study, 70 patients with tinnitus will be selected according to the inclusion criteria including: tinnitus for at least 6 months; normal audiogram test; possibility of follow up; Insensitivity to sertraline, melatonin and benzodiazepine compounds and agreement to participate in this study. Patients who have tinnitus with specific etiology or have a history of recent head trauma will be excluded from the study. Afterward patients will be randomly allocated into two groups. Group 1 or intervention group receive Sertraline 50 mg tablet, once a day and group 2 or control group receive melatonin tablet 3 mg once a day for 3 months. After the end of the treatment courses, we will collect patients’ outcomes’ information using a questionnaire. The main outcome in this study will be tinnitus.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017011412782N13
Registration date:2017-03-30, 1396/01/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-03-30, 1396/01/10
Registrant information
Name
Ali Mehrabi kushki
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 1510
Email address
mehrabi@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Isfahan University of Medical Sciences .
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to compare the effect of sertraline and melatonin on the treatment of tinnitus
Public title
Effect of sertraline and melatonin on tinnitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: tinnitus for at least 6 months; normal audiogram test; possibility of follow up; Insensitivity to sertraline, melatonin and benzodiazepine compounds and agreement to participate in this study.
Exclusion criteria: patients who have tinnitus with specific etiology or have a history of recent head trauma.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Random selection using random numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical sciences, Hezar Jareeb street,Isfahan, Iran
City
Isfahan
Postal code
Approval date
2015-09-23, 1394/07/01
Ethics committee reference number
IR.MUI.REC.1395.30134
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
before intervention and three months after intervention
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients are treated by sertraline, 50 mg oral tablet, once a day for 3 months.
Category
Treatment - Drugs
2
Description
Control group: patients are treated by Melatonin 3 mg oral tablet, once a day for 3 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
AL-Zahra hospital
Full name of responsible person
Dr Seyed Hamid Abtahi
Street address
Alzahra hospital, Alzahra street, Isfahan, Iran
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Isfahan University of Medical Sciences
Full name of responsible person
Dr Mansour Siavash
Street address
Isfahan University of Medical Sciences, Hezar jareeb street, Isfahan, Iran
City
Isfahan
Grant name
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Isfahan University of Medical Sciences
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
Isfahan University of Medical Sciences
Full name of responsible person
Dr.Mahdi Mahmoodi
Position
Resident of Otolaryngology
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar jareeb street, Isfahan, Iran
City
Isfahan
Postal code
7346181746
Phone
+98 31 3668 0048
Fax
Email
Dr.mahdi.mahmoodi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Seyed Hamidreza Abtahi
Position
Otolaryngologist
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezar jareeb street, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 3668 0048
Fax
Email
shrabtahi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University Medical Sciences
Full name of responsible person
Ali Mehrabi Koushki
Position
Responsible for research/Master of Science
Other areas of specialty/work
Street address
Research office , Al-Zahra hospital, Al-zahra street, Isfahan, Iran
City
Isfahan
Postal code
8174675731
Phone
+98 31 3265 1574
Fax
Email
Mehrabi@mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)