Evaluation and comparison of the effect of rivaroxaban on pure tone audiometry and word recognition score in treatment of sudden sensorineural hearing loss
Design
Clinical trial with control group, with parallel groups, double-blind, phase 2 on 34 patients
Settings and conduct
This study will be performed in 1399 in Kashani Educational-Medical Center of Isfahan. Researchers and patients are unaware of the type of drug used.
Participants/Inclusion and exclusion criteria
Patients over 18 years of age with sudden hearing loss without a history of hearing problems or blood coagulation are included in the study.
Intervention groups
Patients in both groups treated with prednisolone 1 mg / kg daily for the first 10 days of illness and intratympanic injection of dexamethasone 5 mg / ml daily for a total of up to 5 days . If patients have a partial response to corticosteroids after 10 days (based on audiometric tests), treatment with prednisolone tablets should be continued for another 10 days until further improvement is found based on audiometric tests.
In the first group, patients receive 10 mg of rivaroxaban tablets daily for 10 days in addition to corticosteroid therapy, while in the second group, patients do not receive any medication other than corticosteroid therapy.
Main outcome variables
PTA level: WRS level: Vitamin D level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110603006699N5
Registration date:2021-03-09, 1399/12/19
Registration timing:prospective
Last update:2021-03-09, 1399/12/19
Update count:0
Registration date
2021-03-09, 1399/12/19
Registrant information
Name
Mehrdad Rogha
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3664 0352
Email address
rogha@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-10, 1399/12/20
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison and evaluation of the effect of rivaroxaban in the complementary treatment of sudden sensorineural hearing loss
Public title
The effect of rivaroxaban on hearing loss
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of SNHL by an ENT specialist
Reduction of more than 30 dB in hearing at least 3 frequencies
Body mass index between 18-30 kg per square meter
Negative pregnancy test in women of reproductive age 15-35 years
Normal coagulation tests
Normal renal function
Regular visits for follow up
Consent to enter the study
Exclusion criteria:
Previous hemorrhagic diseases such as intracranial hemorrhage
Previous coagulation diseases
History of previous thrombosis anywhere on the body
Active stomach ulcers
History of psychiatric diseases
Any previous illness or surgery on the ears
Any signs of inflammation or infection of the ear on examination
History of hearing loss
Meniere's disease
Recent vocal or compressive trauma
Underlying disease that may be the cause of SNHL, such as trauma, autotoxic drugs, infection, etc
Blood pressure higher than 180/110
Uncontrolled diabetes
Hypersensitivity reaction to corticosteroids
Taking drugs such as methadone
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients and researchers are unaware of the type of drug or placebo used, and the drugs are coded with the same shape and packaging.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan university of medical science
Street address
hezar jirib Ave, Isfahan university of medical science
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2020-10-17, 1399/07/26
Ethics committee reference number
ir.mui.med.rec.1399.631
Health conditions studied
1
Description of health condition studied
Decreased sensorineural hearing
ICD-10 code
H90.5
ICD-10 code description
Unspecified sensorineural hearing loss
Primary outcomes
1
Description
Pure tone audiometry Level
Timepoint
Beginning and end of the study
Method of measurement
Audiometric device
2
Description
Word recognition score level
Timepoint
Beginning and end of the study
Method of measurement
Audiometric device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Rivaroxaban 10 mg tablets of the َArena company are received daily for 10 days.
Category
Treatment - Drugs
2
Description
Control group: Placebo tablets with the same shape and color are taken daily for 10 days. Placebo has been prepared in the laboratory of the Faculty of Pharmacy, University of Isfahan.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani hospital
Full name of responsible person
Ehsan moshtaghi
Street address
Ayatollah Kashani Hospital, Ayatollah Kashani Main Street
City
Esfahan
Province
Isfehan
Postal code
۸۳۴۳۴۸۱۸۳۹
Phone
+98 31 3233 0091
Email
ehsan_moshtaghi1989@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
Esfahan University of Medical Science , Hezar Jerib street , Isfahan , Iran
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
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
Ehsan moshtaghi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Esfahan University of Medical Science , Hezar Jerib street , Isfahan , Iran
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
0098312330066
Email
ehsan_moshtaghi1989@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehrdad Rogha
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Hezar jarib street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3664 0352
Fax
+98 31 3233 9021
Email
rogha@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehrdad Rogha,MD
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Otolaryngology ward, Kashani Hospital,Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98312330066
Fax
Email
rogha@med.mui.ac.ir
Web page address
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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available