This study was to compare the effectiveness of the Ginkgo biloba with cinnarizine on the subjective tinnitus and determine the effective dose of Ginko on the patients.
Inclusion criteria included: patients with tinnitus for over 18 years and less than 70 years who had definite pathological examination and exclusion criteria included previous use of drugs Ginkgo biloba, anti-coagulant drug use, history of hypertension, pregnant or planning to get pregnant.
Population of this study was 61 patients with subjective tinnitus that referred ear, nose and throat clinic in 1393. Patients were assigned randomly into two groups Cinnarizine (n = 32patients) and Ginkgo biloba (n = 29) that matched in terms of age and gender. According to literature during the treatment period was 2 months. At baseline and after 2 months of treatment, patients were evaluated with questionnaire of Tinnitus severity index.
After two months of treatment with Ginkgo biloba (120-140 mg per day) tinnitus severity decreased in patients and there are no many differences between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013011212101N1
Registration date:2014-10-19, 1393/07/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-10-19, 1393/07/27
Registrant information
Name
Parastoo Yarmohammadi
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 3352 4328
Email address
yarmohamadi@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of Shahrekord University of medical sciences.
Expected recruitment start date
2012-03-19, 1390/12/29
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing effectiveness of Ginkgo biloba with cinnarizine in tinnitus intencivity of patients with subjective tinnitus
Public title
Effectiveness of Ginkgo biloba in treatment of subjective tinnitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with tinnitus for over 18 years; patients less than 70 years who had definite pathological examination
Exclusion criteria: previous use of drugs Ginkgo biloba, anti-coagulant drug use; history of hypertension; pregnant or planning to get pregnant; to be any unexpected complications, patient dissatisfaction
Age
From 26 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
61
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahrekord University Of Medical Science
Street address
Vice President of Research, Shahrekord University of Medical Sciences,yatollah Kashani Boulevard,Shahrekord ,Chahar Mahal and Bakhtiari
City
shahrekord
Postal code
۸۸۱۵۷۱۳۴۷۱
Approval date
2012-07-14, 1391/04/24
Ethics committee reference number
17-4-91
Health conditions studied
1
Description of health condition studied
Tinnitus
ICD-10 code
H93.1
ICD-10 code description
Tinnitus
Primary outcomes
1
Description
subjective tinnitus
Timepoint
2 months
Method of measurement
Audiometry
Secondary outcomes
empty
Intervention groups
1
Description
Cinnarizine groups: Oral Cinnarizine 75 mg daily in three divided doses for 2 months of treatment
Category
Treatment - Drugs
2
Description
Ginkgo biloba: Oral Ginkgo biloba 120-140 mg daily in 2to 3 divided doses for 2 months of treatment
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahrekord Ayatollah Kashani Hospital
Full name of responsible person
Doctor Hamidreza khazraei
Street address
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research and Technology, Shahrekord University of medical sciences.
Full name of responsible person
Fatemeh Rafiee
Street address
Research Department, Shahrekord University of Medical Sciences,Ayatollah Kashani Boulevard,Shahrekord,Chahar Mahal and Bakhtiari
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research and Technology, Shahrekord 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Dr. Hamid Reza Khazraei
Position
Ear, nose and throat Specialist
Other areas of specialty/work
Street address
School of Medicine,Shahrekord University of Medical Sciences,Shahrekord
City
Shahrekord
Postal code
Phone
+98 38 1226 4830
Fax
Email
A1hamid@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Parastoo Yarmohammadi
Position
MSc Health Education
Other areas of specialty/work
Street address
Kashani hospital, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38 1226 4830
Fax
Email
Yarmohamadi@hlth.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)