1. Home
  2. Approved trials
  3. » فارسی

Evaluation of intra-tympanic dexamethasone with alterations of electrocochleography in meniere's  patients.

Protocol summary

Summary
To assess the effectiveness of intra-tympanic dexamethasone on the frequency and severity of attacks of vertigo, on chronic symptoms such as tinnitus, imbalance and hearing loss, and on the progression of these symptoms in patients with definite meniere’s disease or syndrome, as defined by the AAO-HNS Committee.We also use electrocochleography (ECOG) for evaluation of hydrops before and after of injection. Materials and Metods :A prospective cohort study including 25 adult patients of a tertiary referral ENT clinic whom definite , unilateral meniere's patients and non responsive to medical treatment was selected. also they had no piror ear surgery or other medical comorbidity. Baseline ECOG obtained , treatment with 4 mg ( IT-Dex) , ( 3 doses totally &with a week interval) was carried out. We recorded Post treatment ECOG, one month after 3rd ( IT-Dex) injection , and evaluated clinical sign 6 to 12 months after treatment.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014050112691N2
Registration date: 2014-12-08, 1393/09/17
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-12-08, 1393/09/17
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
Tehran University of Medical Science
Expected recruitment start date
2013-02-28, 1391/12/10
Expected recruitment end date
2014-12-31, 1393/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of intra-tympanic dexamethasone with alterations of electrocochleography in meniere's  patients.
Public title
Evaluation of intra-tympanic dexamethasone in meniere disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Definite meniere ; Age beyond 18 years; NOresponse to medical mangment Exclusion criteria: Musculoskeletal disease ; Spinal cord disease; Middle ear disease ; Addiction ;Usage of ototoxic drugs
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 23
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
Tehran University of Medical Sicence
Street address
Poursinastreet ; 16 azar street ; Keshavarz blvd
City
Tehran
Postal code
Approval date
2014-09-13, 1393/06/22
Ethics committee reference number
23349

Health conditions studied

1

Description of health condition studied
Meniere disease
ICD-10 code
H81.0
ICD-10 code description
Ménière disease

Primary outcomes

1

Description
Vertigo
Timepoint
1 ; 3 and 6 months
Method of measurement
In respect to standardized questionarie

Secondary outcomes

1

Description
tinitus ;hearing level
Timepoint
1 ; 3 and 6 months
Method of measurement
Audiometry / respect to questionarie

Intervention groups

1

Description
4 mg intratympanic dexamethasone injection 3 doses toally with 1 week interval.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Amir-Alam hospital
Full name of responsible person
Reza. Gharibi.MD
Street address
Northern saadi street, Darwaze Dowlat , Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Mrs.Mokhtari
Street address
Poursina street ; Keshavarz blvd ; Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Science
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
Amir Alam hospital
Full name of responsible person
Reza Gharibi
Position
Otorhinolaryngology resident
Other areas of specialty/work
Street address
Northern saadi street, Darwaze dowlat
City
Tehran
Postal code
Phone
+212 166760245
Fax
Email
hessam.gharibi@ymail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sience
Full name of responsible person
Reza Gharibi
Position
Otorhinolaryngology resident
Other areas of specialty/work
Street address
Northern saadi street , Darvaze dowlat
City
Tehran
Postal code
Phone
+98 21 6676 0245
Fax
Email
hessam.gharibi@ymail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Amir Alam hospital
Full name of responsible person
Reza Gharibi
Position
Otorhinolaryngology resident
Other areas of specialty/work
Street address
Northern saadi street , Darwaze Dowlat
City
Tehran
Postal code
Phone
+98 21 6676 0245
Fax
Email
hessam.gharibi@ymail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...