Clinical trials without a control group and not blinded
Settings and conduct
74 patients with a tinnitus complaint who referred to the Clinic of the Ear and Nose of the Khatam Al-Nabia Hospital used 50 mg of Genikobylbao extract three times a day for 12 weeks. The evaluation of tinnitus and treatment was done by questionnaire. Initially, the researcher gave participants 4 forms of information to provide them the necessary explanations. They were asked to fill out the questionnaires before beginning of the treatment, after 4 weeks of treatment, after 12 weeks of receiving the treatment.
Participants/Inclusion and exclusion criteria
Inclusion: Satisfaction with receiving treatment, tinnitus for more than 6 months without any specific cause
Exclusion: Age younger than 18 years of age over 70 years, pregnancy or intent to become pregnant, previous Bilbao extract consumption, tinnitus less than 6 months
Intervention groups
The intervention group included patients with tinnitus. First, they were evaluated for anatomic and clinical findings. If there was a clear structural-clinical defect or exit criteria, the patient was excluded. Patients who were included in the study took 50 mg of Genikobylbao extract 3 times a day for 12 weeks.
Main outcome variables
Tenitus score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180425039418N6
Registration date:2019-06-09, 1398/03/19
Registration timing:registered_while_recruiting
Last update:2019-06-09, 1398/03/19
Update count:0
Registration date
2019-06-09, 1398/03/19
Registrant information
Name
mohammad Ghena'at Pisheh Sanani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3343 1227
Email address
mohammad.ghenaat71@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-17, 1397/07/25
Expected recruitment end date
2019-07-16, 1398/04/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Chinese Ginseng on tinnitus
Public title
Effect of Chinese Ginseng on tinnitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction with receiving treatment
tinnitus for more than 6 months without any specific cause
Exclusion criteria:
Patients under the age of 18 and over 70 years
Patients with a specific cause of tenetius
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of medical sciences
Street address
Medical Sciences Campus, Doctor Hesabi Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2019-09-29, 1398/07/07
Ethics committee reference number
IR.ZAUMS.REC.1398.077
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 score
Timepoint
Before treatment, after 4 weeks of treatment, after 12 weeks of treatment, and finally 4 weeks after treatment
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Use 50 mg of Genikobylbao extract 3 times a day for 12 weeks.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam Al Anbia Hospital
Full name of responsible person
Dr Reza Gharibi
Street address
Amir Al Momenin street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3348 2796
Email
boali@zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr Reza Gharibi
Street address
Dr.Hesabi Square , campus of medical sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5744
Email
public@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Dr Reza Gharibi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Dr. Hesabi square campus of medical sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98167-43175
Phone
+98 543329571522
Email
hessam.gharibi@ymail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr Reza Gharibi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Dr. Hesabi square campus of medical sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98167-43175
Phone
+98 543329571522
Email
hessam.gharibi@ymail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr Reza Gharibi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Dr. Hesabi square campus of medical sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98167-43175
Phone
+98 543329571522
Email
hessam.gharibi@ymail.com
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