Determining the effect of Osvix drug on tinnitus and headache in patients with stenosis or hypoplasia of the transverse venous sinus.
Design
42 available patients were included in the study and were treated with 75 mg of Osvix daily for one month, and before and after the intervention, they were evaluated for the severity of disability caused by headache and tinnitus.
Settings and conduct
42 available patients referred to the neurology clinic of Imam Reza Hospital with symptoms of tinnitus and headache, diagnosed by a neurologist in vascular imaging as having stenosis or hypoplasia of the transverse venous sinus, were included in the study. They are given 75 mg of Osvix daily, and before and after the intervention, they are evaluated in terms of the severity of disability caused by headache and tinnitus by a questionnaire.
Participants/Inclusion and exclusion criteria
Age between 18 and 68 years
Having tinnitus and headache, and unilateral or bilateral stenosis or hypoplasia in the transverse venous sinus evident in MRV
The absence of known neurological diseases leading to tinnitus, Pregnancy and breastfeeding
Intervention groups
42 patients were included in the study and were treated for one month with 75 mg of Osix daily.
Main outcome variables
Reducing the sensation of Tinnitus and headache
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220715055474N1
Registration date:2023-08-12, 1402/05/21
Registration timing:retrospective
Last update:2023-08-12, 1402/05/21
Update count:0
Registration date
2023-08-12, 1402/05/21
Registrant information
Name
Ali Mirzaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4453 4450
Email address
amteh76@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-15, 1402/02/25
Expected recruitment end date
2023-07-23, 1402/05/01
Actual recruitment start date
2023-05-15, 1402/02/25
Actual recruitment end date
2023-07-23, 1402/05/01
Trial completion date
2023-07-23, 1402/05/01
Scientific title
Evaluation of the effect of Osvix on tinnitus and Headache in patient with transverse venous sinus stenosis or hypoplasia
Public title
Evaluation of the effect of Osvix on tinnitus and Headache in patient with transverse venous sinus stenosis or hypoplasia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Tinnitus and headache with venous sinus stenosis or hypoplasia
Exclusion criteria:
Known neurological disease
Pregnancy or breastfeeding
Patient dissatisfaction
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
42
Actual sample size reached:
42
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees AJA University of Medical Sciences
Street address
West Fatemi Street, Shahid Etemad Zadeh Street, Army University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2023-05-15, 1402/02/25
Ethics committee reference number
IR.AJAUMS.REC.1402.033
Health conditions studied
1
Description of health condition studied
Tinnitus and headache and transverse venous sinus stenosis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Severity of disability caused by tinnitus and headache by Tinnitus handicap inventory and Headache disability index
Timepoint
At the beginning of the study and thirty days after the intervention
Method of measurement
Tinnitus handicap inventory and Headache disability index
Secondary outcomes
1
Description
Tinnitus and headache severity score measured by Tinnitus handicap inventory and Headache disability index questionnaires
Timepoint
30 days after the intervention
Method of measurement
Tinnitus and headache severity score measured by Tinnitus handicap inventory and Headache disability index questionnaires
Intervention groups
1
Description
Intervention group:
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Ali Mirzaei
Street address
Fatemi West Street, Shahid Etemadzadeh Street, Imam Reza Hospital
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
mail.ajaums.ac.ir@yahoo.com
Web page address
https://imamreza.ajaums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Vice President of Research and Technology
Street address
West Fatemi Street - Shahid Etemadzadeh Street - Army University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
Amteh76@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Ali Mirzaei
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
West Fatemi St. - Shahid Etemadzadeh St
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
Amteh76@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Ali Mirzaei
Position
Studnt
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
West Fatemi Street - Shahid Etemadzadeh Street - Army University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
Amteh76@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Ali Mirzaei
Position
Studnt
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
West Fatemi Street - Shahid Etemadzadeh Street - Army University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
Amteh76@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available