Evaluating the therapeutic effect of intratympanic dexamethasone and hyaluronic acid combination on Meniere's disease
Design
Clinical trial, without a control group, without blinding
Settings and conduct
Sampling in this study is done in Kashani and Alzahra hospitals in Isfahan. The patients with Meniere's disease are selected based on the American committee of otolaryngology-Head & neck surgery guideline. The intervention group receives two intratympanic injections of 0.3 ml dexamethasone and 0.2 ml hyaluronic acid as a mixture and the interval between two injections is one month. Patients are examined for hearing impairment, vertigo and tinnitus before and two weeks after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with Meniere's disease and resistant to other treatments such as lifestyle modifications, vasodilators or diuretics during the last 6 months.
Exclusion criteria: Nothing.
Intervention groups
The intervention group receives two intratympanic injections of 0.3 ml dexamethasone (manufacture by Abidi company) and 0.2 ml hyaluronic acid (Hyalgan manufacture by Fidia Pharma USA) as a mixture and the interval between two injections is one month.
Main outcome variables
Hearing impairment, vertigo, tinnitus
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130311012782N25
Registration date:2018-12-07, 1397/09/16
Registration timing:registered_while_recruiting
Last update:2018-12-07, 1397/09/16
Update count:0
Registration date
2018-12-07, 1397/09/16
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
Expected recruitment start date
2018-01-01, 1396/10/11
Expected recruitment end date
2018-12-30, 1397/10/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Therapeutic effect of intratympanic dexamethasone and hyaluronic acid combination on Meniere's disease patients
Public title
Effect of dexamethasone and hyaluronic acid combination on Meniere's disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Meniere's disease
Patients resistant to other treatments such as lifestyle modifications, vasodilators or diuretics during the last 6 months
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
Not randomized
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
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2017-08-01, 1396/05/10
Ethics committee reference number
IR.MUI.REC.1396.30455
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
hearing impairment
Timepoint
Before the intervention and 2 weeks after the treatment
Method of measurement
Speech discrimination score
2
Description
Vertigo
Timepoint
Before the intervention and 2 weeks after the treatment
Method of measurement
Dizziness Handicap Inventory
3
Description
Tinnitus
Timepoint
Before the intervention and 2 weeks after the treatment
Method of measurement
Tinnitus Handicap Inventory
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group: Receives two intratympanic injections of 0.3 ml dexamethasone (manufacture by Abidi company) and 0.2 ml hyaluronic acid (Hyalgan manufacture by Fidia Pharma USA) as a mixture and the interval between two injections is one month.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani hospital
Full name of responsible person
Leila Assadpour
Street address
Kashani Hospital, Kashani Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
1435915371
Phone
+98 31 3386 6266
Email
kashani@mui.ac.ir
Web page address
http://kashani.mui.ac.ir
2
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Leila Assadpour
Street address
Alzahra Hospital, Sofe street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alzahra@mui.ac.ir
Web page address
http://alzahra.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
Isfahan University of Medical Sciences, Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 7079
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Leila Assadpour
Position
Non-faculty specialist
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Isfahan University of Medical Sciences, Hezar Jarib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 8597
Email
leilaasadpour35@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Leila Assadpour
Position
Non-faculty specialist
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Isfahan University of Medical Sciences, Hezar Jarib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 8597
Email
leilaasadpour35@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Leila Assadpour
Position
Non-faculty specialist
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Isfahan University of Medical Sciences, Hezar Jarib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 8597
Email
leilaasadpour35@gmail.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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Only the results of the whole data are made available to the public
When the data will become available and for how long
Starting 3 months after publication
To whom data/document is available
Information is provided to Isfahan University of Medical Sciences
Under which criteria data/document could be used
The use of data is merely intended to introduce the study and examine how the parameters are measured
From where data/document is obtainable
Dr. Leila Assadpour (Project manager)
Address: Isfahan University of Medical Sciences, Hezar Jarib street, Isfahan, Iran
Phone: 00983136688597
Mobile: 00989171074662
Email: leilaasadpour35@gmail.com
What processes are involved for a request to access data/document
1. No use these data in another study
2. Member of the Faculty of Medicine of Isfahan University of Medical Sciences
3. No data access to someone else