The comparison of the effect intra tympanic methylprednisolon injection and intra tympanic gentamicin injection in control vertigo in patients with unilateral meniere's disease.
This study aims to compare the effect of intra tympanic methylprednisolon injection versus intra tympanic gentamicin injection in vertigo control. Inclusion criteria: Patients with unilateral meniere's disease;
Exclusion criteria: patients with bilateral meniere's disease; patients whose involved ear is the only hearing ear; not suffering from central nervous system disease; patients who do not let to inject. The experimental group contains 20 patients, Patients are divided into two groups and then 27.6 mg of gentamicin is injected to one group and 62.5 mg metylprednisolon is injected to the other group for three week. Finally the groups vertigo, tinnitus and hearing loss are compared 3 to 6 month after the last injection by questionnaires and radiometry.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015041021582N1
Registration date:2015-05-31, 1394/03/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-05-31, 1394/03/10
Registrant information
Name
Armin Arad
Name of organization / entity
Ahvaz university of medical sciencesy
Country
Iran (Islamic Republic of)
Phone
+98 613367543
Email address
arad.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz university of Medical Sciences
Expected recruitment start date
2014-11-29, 1393/09/08
Expected recruitment end date
2015-05-22, 1394/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effect intra tympanic methylprednisolon injection and intra tympanic gentamicin injection in control vertigo in patients with unilateral meniere's disease.
Public title
The effect of gentamicin and methylprednisolon on vertigo.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with unilateral meniere's disease;
Exclusion criteria: patients with bilateral meniere's disease; patients whose involved ear is the only hearing ear; not suffering from central nervous system disease; dissatisfaction
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of ahvaz university of Medical Sciences
Street address
Ahvaz University of Medical Sciences, Golestan street
City
Ahvaz
Postal code
15794_61357
Approval date
2014-11-29, 1393/09/08
Ethics committee reference number
ajums.rec.1392.292
Health conditions studied
1
Description of health condition studied
Meniere,s disease
ICD-10 code
h81.0
ICD-10 code description
Meniere,s disease
Primary outcomes
1
Description
Vertigo
Timepoint
before treatment and 3 months later
Method of measurement
Questennaire
Secondary outcomes
1
Description
Tinnitus
Timepoint
before treatment and 3 month later
Method of measurement
Questennaire
2
Description
hearing loss
Timepoint
before treatment and 3 month later
Method of measurement
audiometry
Intervention groups
1
Description
intervention group 1- gentamicin with dose 27.6 mg once via intra tympanic injection
Category
Treatment - Drugs
2
Description
intervention group 2- methyl perednosolone with dose 62.5 mg weekly intra tympanic injection in three times
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital of Ahvaz
Full name of responsible person
Armin arad
Street address
Azadegan street, Imam Khomeini Hospital of Ahvaz
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy for research of Avaz University of Medical Sciences
Full name of responsible person
Dr. Nader Saki
Street address
Golestan street, Ahvaz University of Medical Sciences
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy for research of Avaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Armin Arad
Position
Resident of ENT
Other areas of specialty/work
Street address
ENT Department, Imam Khomeini Hospital, 24 Metri Street
City
Ahvaz
Postal code
61357-15794
Phone
+98 613367543
Fax
Email
Aramesh302@Yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Armin Arad
Position
Resident of ENT
Other areas of specialty/work
Street address
ENT Department, Imam khomeini hospital,24 Metri street
City
Ahvaz
Postal code
61357-15794
Phone
+98 613367543
Fax
Email
Aramesh302@Yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Armin Arad
Position
Resident of ENT
Other areas of specialty/work
Street address
ENT Department, Imam khomeini hospital, 24 Metri street
City
Ahvaz
Postal code
61357-15794
Phone
+98 613367543
Fax
Email
aramesh302@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)