To assess the effect of co-enzyme Q10 versus placebo on treatment of tinnitus due to presbycusis
Design
This is a triple-blind randomized clinical trial, phase II, in which 50 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients with tinnitus due to presbycusis referring to the Besat Hospital in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the drawing of lots. This trial will be triple-blinded so that neither patients nor the physician examining the patients and nor the data analyzer will be aware of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 50 to 90 years,
Tinnitus for over a year,
Bilateral neural sensorineural hearing loss
Exclusion criteria:
Psychosomatic disorder,
Consumption of calcium, vitamin, and magnesium in the past two months,
Tinnitus due to drug side effects,
Atypical tinnitus,
Meniere's disease,
Conductive hearing loss
Intervention groups
Intervention group:
Neurotriptyline tablet 25 mg (manufactured by Darupakhsh Pharmaceutical Co.) daily plus co-enzyme Q10 tablet 100 mg (manufactured by Health Aid Co.) daily for 6 weeks
Control group:
Neurotriptyline tablet 25 mg (manufactured by Darupakhsh Pharmaceutical Co.) daily plus placebo tablet 100 mg daily for 6 weeks
Main outcome variables
Primary outcome:
The severity of tinnitus, sleep disorder, quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N339
Registration date:2020-02-07, 1398/11/18
Registration timing:registered_while_recruiting
Last update:2020-02-07, 1398/11/18
Update count:0
Registration date
2020-02-07, 1398/11/18
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-02-19, 1398/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of co-enzyme Q10 versus placebo on treatment of tinnitus due to presbycusis: a triple-blind randomized clinical trial
Public title
Effect of co-enzyme Q10 versus placebo on treatment of tinnitus due to presbycusis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 50 to 90 years,
Tinnitus for over a year,
Bilateral neural sensorineural hearing loss
Exclusion criteria:
Psychosomatic disorder,
Consumption of calcium, vitamin and magnesium in the past two months,
Tinnitus due to drug side effects,
Atypical tinnitus,
Meniere's disease,
Conductive hearing loss
Age
From 50 years old to 90 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "intervention" on one sheet and "control" on another. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or
Blinding (investigator's opinion)
Triple blinded
Blinding description
The drugs will be given in coded envelopes. The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. The analyzer will be unaware of the type of interventions Thus, the trial will be run as triple-blind
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2019-07-06, 1398/04/15
Ethics committee reference number
IR.UMSHA.REC.1398.301
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
Before the intervention and 6 months later
Method of measurement
Using the Tinnitus Handicap Inventory (THI)
2
Description
Sleep disorder
Timepoint
Before the intervention and 6 months later
Method of measurement
Using the Petersburg questionnaire
3
Description
Quality of life
Timepoint
Before the intervention and 6 months later
Method of measurement
Using the SF-36 questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Neurotriptyline tablet 25 mg (manufactured by Darupakhsh Pharmaceutical Co.) daily plus co-enzyme Q10 tablet 100 mg (manufactured by Health Aid Co.) daily for 6 weeks
Category
Treatment - Drugs
2
Description
Control group: Neurotriptyline tablet 25 mg (manufactured by Darupakhsh Pharmaceutical Co.) daily plus placebo tablet 100 mg daily for 6 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital in Hamadan city
Full name of responsible person
Dr Zahra Sadeghi
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
sazcsaz66@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr Zahra Sadeghi
Position
Resident of ENT
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
sazcsaz66@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Rooholah Abbasi
Position
Otolaryngologist
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
Ruholah@abasihatmil.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.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