Assessment and comparison of recovery rate, incidence of complications, and satisfaction rate in patients received gabapentin or placebo referred to Al-Zahra Hospital Ear, Nose and Throat Clinic in 2020-2021 based on TSI questionnaire
Design
Completely randomized Clinical trial with control group, double-blind on 56 patients.
Settings and conduct
This trial will be performed as a randomized double blind placebo control design from 1398 to 1399. The subjects included all patients with idiopathic tinnitus referred to the Ear, Nose and Throat Clinic of Al-Zahra Hospital in 1998-99, who were followed up monthly for 12 weeks after the intervention.
Participants/Inclusion and exclusion criteria
ٍAll the patient with idiopathic tinnitus referred to the ENT clinic of the Al-Zahra hospital
Age between 18 and 65
Satisfaction of entering the study
Patient assistance to use the drug
No pregnancy , lactescent, or design to pregnancy in the next 6 months
Normal audiometry test
Use narcotic or alcohol or sedative drugs in the past 48 hours
Use MAOI, SSRI, TCA ,phenothiazine, soporific drugs in the past
Sensitivity to gabapentine
No satisfaction of being a case study in this study
No assistance to use the drug
Patient with pulsative tinnitus
Patient with acute / choronic internal or middle ear infection
Patient with thyroid disease
Patient with rheumatologic disease
Deals with noisy workplace
Age more than 65 years
Simultaneous use of other drugs except for gabapentin
Intervention groups
In this study, participants will receive two interventions of gabapentin and placebo. Groups A or B of participants will be treated with gabapentin (300 mg daily) or placebo for 12 weeks.
Main outcome variables
Tinitus score in tinnitus severity index questionnaire; visual analogue scale; satisfaction rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200127046283N1
Registration date:2020-06-10, 1399/03/21
Registration timing:prospective
Last update:2020-06-10, 1399/03/21
Update count:0
Registration date
2020-06-10, 1399/03/21
Registrant information
Name
Mohsen Rashidi ravari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3341 4754
Email address
rashidi.sd@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-22, 1399/04/02
Expected recruitment end date
2021-04-19, 1400/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of gabapentin with placebo on Idiopathic tinnitus
Public title
The efficacy of gabapentin on tinnitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All the patient with idiopathic tinnitus referred to the ENT clinic of the Al-Zahra hospital
Age between 18 and 65
Satisfaction to enter this study
Patient assistance to use the drug
No pregnancy , lactescent, or plan to pregnancy in the next 6 months
Normal audiometry test
Exclusion criteria:
Use narcotic or alcohol or sedative drugs in the past 48 hours
Use MAOI, SSRI, TCA ,phenothiazine, soporific drugs in the past
Sensitivity to gabapentine
No satisfaction with being a case study in this study
No assistance to use the drug
Patient with pulsative tinnitus
Patient with acute / choronic internal or middle ear infection
Patient with thyroid disease
Patient with rheumatologic disease
Deals with noisy workplace
Age more than 65 years
Simultaneous use of other drugs except for gabapentin
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Method of randomization: simple
Unit of randomization: individual
Tools used in randomization: table of random numbers.
patient assignment in groups A and B will be done based on a completely randomized design.
To prevent bias in our study a double-blind design will be performed. Both analgesics are in separate boxes A and B, and only the ENT specialist is aware of the drug's content in each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients will be treated with prescribed medication packages by an ENT specialist. Drug packages are quite similar in shape, and the patient and project manager are unaware of the contents of the packages. Data gathering, patient analysis and filling the forms will be done by investigator and the assistant who are not aware of the contents of the packages; In the data analysis step, the analysis will be done by the project advisor and the investigator, who are not aware of the contents of the drug packages, and groups of patients (groups 1 or 2) will be defined for the data analysis. Therefore, the study is a double blind study and from the stage of the patient's entry into the study to the study phase, data collection and data analysis, the contents of the two drug groups are not clear.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of zahedan university of medical sciences
Street address
Alzahra Hospital; Motahari Blvd; Zahedan Town
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816737789
Approval date
2020-01-05, 1398/10/15
Ethics committee reference number
IR.ZAUMS.REC.1398.377
Health conditions studied
1
Description of health condition studied
Idiopathic tinnitus
ICD-10 code
H93.1
ICD-10 code description
Tinnitus
Primary outcomes
1
Description
the score of tinnitus in tinnitus severity index questionnaire and visual analogue scale
Timepoint
The amount of tinnitus at the beginning of the study and 1, 2 and 3 months after starting the drug and placebo will be measured.
Method of measurement
Tinnitus severity index questionnaire, visual analogue scale and 5 point scale for satisfaction
Secondary outcomes
1
Description
Side effects of prescribed drug
Timepoint
1-2-3 months after using drug
Method of measurement
ask about vertigo، nasea، drowsiness، biurred vision ،fatigue
Intervention groups
1
Description
Intervention group: The treated individuals included all patients with idiopathic tinnitus referred to the ETN Clinic of Al-Zahra Hospital in 1998-99, for 12 weeks after the intervention with gabapentin (300 mg daily, made by Razak Company, Tehran, Iran). They are followed up on a monthly basis. The group will be treated for 12 weeks.
Category
Treatment - Drugs
2
Description
Control group: Control individuals included all patients with idiopathic tinnitus referred to the ETN Clinic of Al-Zahra Hospital in 1998-99, which were followed up monthly for 12 weeks after the intervention with placebo. The group will also be reviewed for 12 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
the ENTclinic of Alzahra hospital in Zahedan
Full name of responsible person
Mohsen Rashidi Ravari
Street address
Motahari Blvd،before Khatam square، Zahedan Town
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816737789
Phone
+98 54 3321 4157
Email
rashidi.sd@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Prof. Nourmohammad Bakhshani
Street address
Motahari Blvd،before Khatam square، Zahedan Town
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816737789
Phone
+98 54 3321 4157
Email
rashidi.sd@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Mohsen Rashidi ravari
Position
Assictant professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Motahari Blvd; before Khatam square; Zahedan Town
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816737789
Phone
+98 54 3321 4157
Fax
Email
rashidi.sd@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Zahra Ghiasi
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Imam Khomeini Ave; In front of Ghale office; Baharan hospital
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9819713955
Phone
+98 54 3351 3779
Email
linooshghiasi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mohsen Rashidi ravari
Position
Assictant professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Arash26_first door on the right side
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9817764154
Phone
+98 54 3341 4754
Fax
Email
rashidi.sd@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All un-deidentified data will be shared once collecting.
When the data will become available and for how long
Starting one year after publication
To whom data/document is available
The outcome will be shared with academic institutes or people working in businesses
Under which criteria data/document could be used
Research Ethics Committee
From where data/document is obtainable
Raw data
rashidi-darya@gmail.com
What processes are involved for a request to access data/document