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Comparing of Gabapentin and Cinnarizine Effect on Tinnitus in Patients with Sensorineural Hearing Loss

Protocol summary

Study aim
Comparing of Gabapentin and Cinnarizine effect on tinnitus in patients with Sensorineural Hearing Loss and Ability to provide a safe, non-invasive, effective and economical treatment for patients with Tinnitus
Design
Two arm parallel group randomized trial with 114 patients, Randomization with a table of random numbers on an online site
Settings and conduct
114 patients who referred to the ENT clinic of Imam Khomeini Hospital in Urmia with a complaint of Tinnitus and have sensorineural hearing loss and have entry condition and do not have the non-entry condition of the study after completing the consent form by the patients for participation In this study, taking a complete history and performing examinations, and if needed, performing audiometry and necessary tests, the THI questionnaire will be completed for them. Patients are randomly divided into two groups, A and B (A: Gabapentin, B: Cinnarizine), and are treated for 6 weeks, and after the completion of the treatment period, they return to complete the THI questionnaire.
Participants/Inclusion and exclusion criteria
Entry condition: Age:18-75 years old, Having persistent and pulseless Tinnitus for at least one year, Having Sensorineural Hearing Loss, Obtaining a score of 38 and above in the Tinnitus Handicap Inventory (THI) questionnaire, Non-entry condition: Having an active Meniere's disease, Being pregnant or breastfeeding, Having any one of the following: Glaucoma, Urinary Retention, Prostatic Hypertrophy, Epilepsy, and Liver disease, Having a health condition that prohibits the use of gabapentin for the patient and other contraindications
Intervention groups
A: Gabapentin 100mg/d 1st week, 300mg/d 2nd week, 900mg/d 3rd and 4th weeks, 300mg/d 5th week, 100mg/d 6th week B: Cinnarizine 25mg/d 1st week, 50mg/d 2nd week, 75mg/d 3rd and 4th weeks, 50mg/d 5th week, 25mg/d 6th week
Main outcome variables
Tinnitus severity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221002056073N1
Registration date: 2022-10-09, 1401/07/17
Registration timing: prospective

Last update: 2022-10-09, 1401/07/17
Update count: 0
Registration date
2022-10-09, 1401/07/17
Registrant information
Name
Reza Samarei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3345 7286
Email address
samareireza@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-23, 1401/08/01
Expected recruitment end date
2023-02-19, 1401/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing of Gabapentin and Cinnarizine Effect on Tinnitus in Patients with Sensorineural Hearing Loss
Public title
Comparing of Gabapentin and Cinnarizine Effect on Tinnitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient has continuous tinnitus without pulsation for at least one year. Having sensorineural hearing loss Based on the Tinnitus Handicap Inventory (THI), the patient must have scored 38 or higher.
Exclusion criteria:
Having active Meniere's Disease Having Kidney Dysfunction Being pregnant or breastfeeding Having any of the following: Glaucoma, Urinary Retention, Prostate Hypertrophy, Epilepsy and Liver Disease Having a health condition that prohibits the use of Gabapentin for the patient or other Contraindications
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 114
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be grouped into two groups, A and B, where group A will receive Gabapentin and group B will receive Cinnarizine. In this way, the number between 1 and 114 will be applied to the patients in the order of entering the study, and then using the website https://www.graphpad.com/quickcalcs, a table of random numbers with two groups will be randomized online. We will create A and B with 57 numbers in each group from numbers 1 to 114.
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
Research Ethics Committees of Urmia University of Medical Sciences - Imam Khomeini University Hospit
Street address
Imam Khomeini University Hospital, Ershad Ave., Modarres Blvd.
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Approval date
2022-02-09, 1400/11/20
Ethics committee reference number
IR.UMSU.HIMAM.REC.1401.015

Health conditions studied

1

Description of health condition studied
Tinnitus
ICD-10 code
H93.1
ICD-10 code description
Tinnitus

Primary outcomes

1

Description
Severity of tinnitus
Timepoint
At the beginning of the study (before the start of the intervention) and 6 weeks after starting the medication
Method of measurement
Tinnitus Handicap Inventory Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Cap Gabapentin 100mg/d 1st week, 300mg/d 2nd week (100mg q8h), 900mg/d 3th and 4th weeks (300mg q8h), 300mg/d 5th week (100mg q8h), 100mg/d 6th week- oral administration
Category
Treatment - Drugs

2

Description
Control group: Tab Cinnarizine 25mg/d 1st week, 50mg/d 2nd week (25mg q12h), 75mg/d 3th and 4th weeks (25mg q8h), 50mg/d 5th week (25mg q12h), 25mg/d 6th week- oral administration
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini University Hospital
Full name of responsible person
Reza Samarei
Street address
Imam Khomeini University Hospital, Ershad Ave., Modarres Blvd.
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Phone
+98 44 3345 9538
Email
samarai.r@umsu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Saber Gholizadeh
Street address
Research and Technology Vice-Chancellor Building, Headquarters of Urmia University of Medical Sciences, Emergency St., Resalat Blvd.
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3193 7224
Email
saber@umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Reza Samarei
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Imam Khomeini University Hospital, Ershad Ave., Modarres Blvd.
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Phone
+98 44 3345 9538
Email
samarai.r@umsu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Reza Samarei
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Imam Khomeini University Hospital, Ershad Ave., Modarres Blvd.
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Phone
+98 44 3345 9538
Email
samarai.r@umsu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Reza Samarei
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Imam Khomeini University Hospital, Ershad Ave., Modarres Blvd.
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Phone
+98 44 3345 9538
Email
samarai.r@umsu.ac.ir

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
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