Tinnitus is a common disorder in general population and affect many age groups. Permanent tinnitus is seen in 6-30% of general population, and 25% of these cases ( about 4% general population) tinnitus is very severe that leads to physical and psychological disorders and hampers their quality of life. Recently, the researchers in this field, believe that tinnitus is a seizure type activity in the cortical and sub cortical areas of the brain that leads to aberrant acoustic perception. Therefore anti epileptic agents have been suggested for decrease of tinnitus intensity and relief of the patients from annoying tinnitus. After initial examination the tinnitus subjects by otolaryngologist, the patients will be recruited into the study. Audiometry and tinnitus tests will be performed and then, the patients explain their tinnitus intensity by use of VAS. Also the tinnitus severity index (TSI) questionnaire will be completed for them. After explaining the prossess of the trial, written informed consent will be obtained from participants. Then they will be divided into three groups randomely: for the first group; carbamazepine, for the second group; oxcarbazepine; and for the third group placebo will be administered for 3 months (12 weeks). At the end of 8th and 12th weeks of study tinnitus intensity will be evaluate by VSA criteria and tinnitus quality and patient quality of life will be re-evaluated using TSI questionnaire. Then the results of intervention in three groups will be analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903061138N2
Registration date:2010-05-27, 1389/03/06
Registration timing:prospective
Last update:
Update count:0
Registration date
2010-05-27, 1389/03/06
Registrant information
Name
Fataneh Bakhshi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1223 8307
Email address
entrc@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical sciences, Vice chancellor for Research
Expected recruitment start date
2010-08-21, 1389/05/30
Expected recruitment end date
2011-04-21, 1390/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Carbamazepine and Oxcarbazepine effect on Tinnitus in patients referred to
Amir Almomenin Hospital rasht-iran.
Public title
Effect of Carbamazepine and Oxcarbazepine on Tinnitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1-tinnitus history more than 6 months; 2- The patients 21-65 years with nonpulsatile tinnitus.
Excllusion crateria:1-pulsatile tinnitus 2-mineare's disease 3-vestibular neurinoma 4-otosclerosis 5-the patients use of hearing-aid 6-pregnancy 7- patients with psychologic disorders need to treatment 8-the nontulerance minimal dose of carbamazepine and oxcarbazepine or hypersensitivity to these drugs 9-recent treatment with anti convulsion drugs 10-OCP consumptions and the drugs interaction with carbamazepine but are necessary to patients 10-patients with severe heart disease(CHF,IHD) 11- appearance severe drug hypersensitivity reaction during of treatment
Age
From 20 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
57
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
Guilan University of Medical Sciences
Street address
Amiralmomenin Hospital
City
Rasht
Postal code
41439
Approval date
2010-05-22, 1389/03/01
Ethics committee reference number
1023/132/پ
Health conditions studied
1
Description of health condition studied
nonpulsatile tinnitus
ICD-10 code
H83
ICD-10 code description
Other diseases of inner ear
Primary outcomes
1
Description
Tinnitus severity
Timepoint
The beginning of treatment and ending of 8th and 12th week
Method of measurement
VAS & TSI
2
Description
Quality of Life
Timepoint
The beginning of treatment and ending of 8th and 12th week