study on effectiveness of methyl prednisolon intratempanic injection in compared to dexametason indoenphatic hydrops and tinnitus cure in definite menier pationts with using of ECOG test
Objective: study on effectiveness of methyl prednisolon intratempanic injection in compared to dexametason indoenphatic hydrops and tinnitus cure in definite menier pationts
Design: clinical trial
Setting and conduct: Definite Meniere's disease Amir Alam hospital for three months did not respond to routine treatment were enrolled and randomly divided into two groups. In a intratympanic injections of methyl prednisolone (40mg / 1ml) and the other group intratympanic injection of dexamethasone (8 mg / 2ml) done.
Inclusion criteria: Patients between 18 and 80 years, did not respond to treatment salt restriction, diuretics and betahistine for three months
Exclusion criteria: Disease of neuromuscular system, diseases of the spinal cord and CNS disease of the middle ear, otitis media, conductive hearing loss, taking ototoxic, drug addiction, patients with a history of middle ear surgery, surgical intervention in the inner ear, patients by menier bilateral and perforation of the tympanic membrane and absence of systemic corticosteroid treatment
Intervention: 41 patients with definite Meniere clinic under local anesthesia in each group and prednisone or dexamethasone intratympanic injection for intratympanic. Three injections can be done within a week. Two to 4 weeks after injection, electrocochleography test will be performed.
No control group
Main outcome measures (variables): Improvement in vertigo
General information
Acronym
تست الکتروکوکلئوگرافی
IRCT registration information
IRCT registration number:IRCT2015102912691N3
Registration date:2016-01-19, 1394/10/29
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-01-19, 1394/10/29
Registrant information
Name
Nasrin Yazdani
Name of organization / entity
Tehran univesity of Medical Sciences, Amir Alam Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 6676 0269
Email address
n_yazdani@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
study on effectiveness of methyl prednisolon intratempanic injection in compared to dexametason indoenphatic hydrops and tinnitus cure in definite menier pationts with using of ECOG test
Public title
study on effectiveness of methyl prednisolon intratempanic injection in compared to dexametason indoenphatic hydrops and tinnitus cure in definite menier pationts
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients between 18 and 80 years, did not respond to treatment salt restriction, diuretics and betahistine for three months
Exclusion criteria: Disease of neuromuscular system, diseases of the spinal cord and CNS disease of the middle ear, otitis media, conductive hearing loss, taking ototoxic, drug addiction, patients with a history of middle ear surgery, surgical intervention in the inner ear, patients by menier bilateral and perforation of the tympanic membrane and absence of systemic corticosteroid treatment
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
41
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not 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 Tehran University of Medical Sciences
Street address
Ghods Street, Keshavarz Boulevard
City
Tehran
Postal code
1417653761
Approval date
2015-06-25, 1394/04/04
Ethics committee reference number
IR.TUMS.REC.343
Health conditions studied
1
Description of health condition studied
Meniere
ICD-10 code
H81.0
ICD-10 code description
Ménière disease
Primary outcomes
1
Description
Vertigo
Timepoint
Arrival, 2 to 4 weeks, every 6 weeks for 6 to 12 months
Method of measurement
Audiometery Test and questionnaire
Secondary outcomes
1
Description
hearing
Timepoint
Arrival, 2 to 4 weeks, every 6 weeks for 6 to 12 months
Method of measurement
Audiometry Test
2
Description
Tinnitus
Timepoint
Arrival, 2 to 4 weeks, every 6 weeks for 6 to 12 months
Method of measurement
questionnaire
Intervention groups
1
Description
Intrevention group 1: 41 patients with definite Meniere intratympanic methyl prednisolone injections at the clinic undergoing local anesthesia for intratympanic.
Category
Treatment - Drugs
2
Description
Intervention group 2: 41 patients with definite Meniere intratympanic dexamethasone injections at the clinic undergoing local anesthesia for intratympanic.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
AmirAlam Hospital
Full name of responsible person
Dr Nasrin Yazdani
Street address
Amir Alam Hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellorfor Research, Tehran University of Medical Sciences
Full name of responsible person
Dr Masoud Younesian
Street address
Central Organization of Tehran University of Medical Sciences, Ghods Street, Keshavarz Boulevard
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellorfor Research, Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr Elham Masoumi
Position
Resident
Other areas of specialty/work
Street address
AmirAlam Hospital
City
Tehran
Postal code
1145765111
Phone
+216 6760269
Fax
+98 21 6676 0269
Email
elham.masoumi177@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Nasrin Yazdani
Position
Associated Professor
Other areas of specialty/work
Street address
AmirAlam Hospital
City
Tehran
Postal code
1145765111
Phone
+216 6703037
Fax
Email
n_yazdani@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Elham Masoumi
Position
Resident
Other areas of specialty/work
Street address
AmirAlam Hospital
City
Tehran
Postal code
1145765111
Phone
+98 21 6676 0269
Fax
+98 21 6676 0269
Email
elham.masoumi177@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)