In this double-blind randomized clinical trial the therapeutic effect of Neurotec on improvement of Tinnitus was investigated. Hundred patients with chief complaint of Tinnitus were examined and diagnosed by a single otolaryngologist and were randomly allocated to two intervention and control group using random number table. Patients with Informed consent, Tinnitus for at least 6 months and Age over 19 were included in the trial. Patients with Pregnancy, Age over 75 and under 19, Chronic or Acute neurologic disease, Psychologic disease, Previous surgery on the affected ear, Pulsatile Tinnitus, Epilepsy, Multiple sclerosis, History of sever trauma to head and neck and History of treatment 1 month prior to intervention were excluded from the trial.Patients in intervention group underwent treatment with Neurotec 100 mg (twice daily) and patients in control group underwent treatment with placebo in the same manner. All the patients received the main treatment which is education and reassurance. All patients in both groups underwent Pure Tone Audiometry (PTA) and filled Tinnitus Handicap Inventory (THI) before, one month and 3 months after intervention and the results were compared together.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017042817413N23
Registration date:2017-05-29, 1396/03/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-05-29, 1396/03/08
Registrant information
Name
Hamidreza Karimi-Sari
Name of organization / entity
Student Research Committee, Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8126 4354
Email address
hrkarimisari@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research Baqiyatallah University of Medical Sciences
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2017-04-21, 1396/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Nuerotec on Improving of Tinnitus signs and symptoms
Public title
Therapeutic effects of Neurotec on Improving Tinnitus in patients attending to Baqiyatallah Clinic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
1- Informed consent
2- Tinnitus for at least 6 months
3- Age over 19
Exclusion criteria:
1-Pregnancy
2-Age over 75 and under 19
3-Chronic or Acute neurologic disease
4-Psychologic disease
5-Previous surgery on the affected ear
6-Pulsatile Tinnitus
7-Epilepsy
8-Multiple sclerosis
9- History of sever trauma to head and neck
10- History of treatment 1 month prior to intervention
Age
From 19 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Baqiyatallah University of Medical Sciences
Street address
Nosrati ave., South Sheykh Bahaei, Mollasadra st., Vanaq sq., Tehran
City
Tehran
Postal code
Approval date
2016-08-01, 1395/05/11
Ethics committee reference number
IR.BMSU.REC.1395.176
Health conditions studied
1
Description of health condition studied
Tinnitus
ICD-10 code
H93.1
ICD-10 code description
Tinnitus
Primary outcomes
1
Description
Hearing Threshold
Timepoint
Before, one month and three months after interventin
Method of measurement
Pure Tone Audiometry
2
Description
Quality of Life
Timepoint
Before, one month and three months after interventin
Method of measurement
Tinnitus Handicap Inventory
Secondary outcomes
1
Description
Drug Complications
Timepoint
During study
Method of measurement
Patients' complaint
Intervention groups
1
Description
Intervention group underwent treatment with Neurotec capsule 100 mg twice daily for 3 months
Category
Treatment - Drugs
2
Description
Control group patients underwent treatment with placebo twice daily for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah Hospital
Full name of responsible person
Mohammad Hossein Khosravi
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Baqiyatallah University of Medical Sciences
Full name of responsible person
Morteza Izadi
Street address
Baqiyatallah University of Medical Sciences, Nosrati Alley, Sheykh Bahaei st., Mollasadra st., Vanaq sq., Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Baqiyatallah 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
Student Research Committee, Baqiyatallah University of Medical Sciences, Tehran, Iran