This research is planned to study effectiveness of Alprazolam on non-pulsative tinnitus in patients referred to Amiralmomenin Hospital. 30 patients who have non- pulsative tinnitus for more than 1 year and have not anxiety or depressive disorders will be recruited. At the first, patients are given Chlordiazepoxide (5 mg bid for 14 days). Then eligible patients, who have good cooperation, are selected. After signing informed consent, these patients will be randomized into two groups. In one group Alprazolam (starts with 0.5 mg and increases to 1.5 mg) and in other group active placebo will be given. After 8 weeks, drugs will taper and discontinue completely in 6 days. After 2 weeks washout span, drugs will continue for 8 weeks as cross-over. Primary outcome in this study is severity of tinnitus (through Visual Analog Scale and Tinnitus Handicap Inventory) and tinnitus test (including Loudness matching). Primary outcome will be measured before and during the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138709121483N1
Registration date:2009-01-01, 1387/10/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-01-01, 1387/10/12
Registrant information
Name
Mir Mohammad Jalali
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1324 3085
Email address
mmjalali@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Pro-vice chancellor, Guilan University of Medical Sciences and Health Services
Expected recruitment start date
2006-11-21, 1385/08/30
Expected recruitment end date
2008-04-19, 1387/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of alprazolam effect on tinnitus
Public title
Evaluation of alprazolam effect on tinnitus in the patients of Rasht Amiralmomenin Hospital
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1- Duration of tinnitus more than 1 year 2- Non pulsative tinnitus
Exclusion criteria:1- pulsative tinnitus 2- Meniere's disease 3- Vestibular Schwannoma 4-Otosclerosis 5-Hearing aid users 6- Temporal lobe tumor 7-Depression 8-Anxiety 9- Unable to tolerate minimal effective dose (0.5 mg Alprazolam bid)
Age
From 21 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Guilan University of Medical Sciences
Street address
Namjoo street- Rasht
City
Rasht
Postal code
Approval date
2006-08-19, 1385/05/28
Ethics committee reference number
3758/132/3/پ
Health conditions studied
1
Description of health condition studied
Tinnitus
ICD-10 code
H93.1
ICD-10 code description
Tinnitus
Primary outcomes
1
Description
tinnitus severity
Timepoint
at -3, 0, 8, 10, 18th week
Method of measurement
Tinnitus Handicap Inventory questionnaire
2
Description
tinnitus test
Timepoint
at -3, 0, 8, 10, 18th week
Method of measurement
loudness matching
3
Description
Severity of Tinnitus
Timepoint
at -3, 0, 8, 10, 18th week
Method of measurement
Visual Analog Scale
Secondary outcomes
empty
Intervention groups
1
Description
Alprazolam 0.5 mg daily for 2 weeks, then 0.5 mg bid for 2 weeks, then 0.5 mg tid for 4 weeks, then 0.5 mg bid for 3 days, then 0.5 mg daily for 3 days
Category
Treatment - Drugs
2
Description
Chlorpheniramine 0.5 mg daily for 2 weeks, then 0.5 mg bid for 2 weeks, then 0.5 mg tid for 4 weeks, then 0.5 mg bid for 3 days, then 0.5 mg daily for 3 days
Category
empty
3
Description
Chlordiazepoxide 5 mg bid for 14 days before initiating the main interventions.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin hospital
Full name of responsible person
Dr Mir Mohammad Jalali
Street address
17 Sharivar street, Melli Bank sq
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr abdolrasol Sobhani
Street address
Mellat St., Namjoo Ave.
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Dr Sapideh Hajforosh
Position
Otolaryngology resident
Other areas of specialty/work
Street address
Amiralmomenin hospital, 17 Sharivar street, Melli Bank sq
City
Rasht
Postal code
Phone
+98 13 1223 8307
Fax
Email
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Mir Mohammad Jalali
Position
Assisstant professor
Other areas of specialty/work
Street address
Amiralmomenin hospital,17 Sharivar street, Melli Bank sq
City
Rasht
Postal code
Phone
+98 13 1223 8307
Fax
+98 13 1324 1842
Email
mmjalali@gums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Mir Mohammad Jalali
Position
Assisstant Professor
Other areas of specialty/work
Street address
Amiralmomenin hospital,17 Sharivar street, Melli Bank sq
City
Rasht
Postal code
Phone
+98 13 1223 8307
Fax
+98 13 1324 1842
Email
mmjalali@gums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)