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Comparing the therapeutic effects of oral corticosteroid, intratympanic corticosteroid and combined approach in patients with sudden sensorineural hearing loss

Protocol summary

Summary
Sudden Sensorineural Hearing Loss (SSNHL) is an emergency issue in the field of ENT.The present study was designed to compare the therapeutic effects of 3 modalities among 150 subjects: group1) receiving oral prednisolone for 10 days (75mg). They will also be administered 0.6ml of placebo at days 1,5,9, and 13 intratympanically. group2) receiving 0.6ml of methyl prednisolone intratympanically at days 1,5,9, and 13 as well placebo orally. group3) receing prednisolone as group 1 and methyl prednisiolone as group 2 protocol. Meanwhile, serum level of TG, cholesterol, FBS, HBA1C, LDL, HDL, ESR, RF, ANA, and FTA-ABS will be assessed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201202159039N1
Registration date: 2012-03-12, 1390/12/22
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-03-12, 1390/12/22
Registrant information
Name
Shahin Bastaninezhad
Name of organization / entity
Dep. ENT, AmirAlam Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 6676 0269
Email address
shahinbastani@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
ENT research cneter, Tehran University of Medical Sciences
Expected recruitment start date
2012-02-20, 1390/12/01
Expected recruitment end date
2013-02-18, 1391/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the therapeutic effects of oral corticosteroid, intratympanic corticosteroid and combined approach in patients with sudden sensorineural hearing loss
Public title
Ttreating sudden sensorineural hearing loss
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All patients with SSNHL referring to Amiralam hospital within the first 10 day of onset Exclusion criteria: receiving therapy in other centers; contraindication to corticosteroid such as pregnancy, diabetus mellitus, etc; previous history of SSNHL; immunocompromised subjects; fluctuating SNHL; previous history of hydropsis; history of brain pathology or temporal bone pathology; concurrent acute or chronic otitis; VDRL-positive cases; uncoopearte subjects; refering after 10 days.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
None
Secondary trial Id
None
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences, Ethics Committee
Street address
Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2011-12-30, 1390/10/09
Ethics committee reference number
90-03-48-15295-42721

Health conditions studied

1

Description of health condition studied
Idiopathic sudden sensorineural hearing loss
ICD-10 code
H91.2
ICD-10 code description
Sudden hearing loss NOS

Primary outcomes

1

Description
Hearing loss
Timepoint
Before trial, one and 4 weeks following the intervention
Method of measurement
Audiometry

Secondary outcomes

empty

Intervention groups

1

Description
Group 1) Oral prednisolone (75mg) for 10 days, and 0.6ml of intratympanic placebo at days 1,5,9,13
Category
Treatment - Drugs

2

Description
Group 2) 0.6ml intratympanic methyl prednisolone at days 1,5,9,13 and oral placebo for 10 days
Category
Treatment - Drugs

3

Description
Group 3) oral prednisolone like group 1 and intratympanic methyl prednisolone like group 2
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Amiralam Hospital
Full name of responsible person
Farzad Firouzi, MD
Street address
South Saadi, Amiralam Hospital
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
ENT Research center, Tehran University of Medical Sciences
Full name of responsible person
Khorsandi Mohammadtaghi, MD
Street address
Amiralam Hospital
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
ENT Research center, 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
ENT Reaserch center
Full name of responsible person
Farzad Firouzi, MD
Position
ENT Resident
Other areas of specialty/work
Street address
North Saadi Street, Amiralam Hospital
City
Tehran
Postal code
Phone
+98 21 6676 0269
Fax
Email
firouzifar1975@razi.tums.ac.irfirouzifar1975@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Bastaninezhad, MD
Position
Assistant professor
Other areas of specialty/work
Street address
Amiralam Hospital
City
Tehran
Postal code
Phone
+98 21 6676 0269
Fax
Email
shahinbastani@razi.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
ENT research Center, Tehran University of Medical Sciences
Full name of responsible person
Farzad Firouzi, MD
Position
Other areas of specialty/work
Street address
Amiralam Hospital, North Saadi Street
City
Postal code
Phone
Fax
Email
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
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