Determination and Comparison of the Effect of cinnarizine and betahistine on the treatment of vertigo in patients referring to Imam Ali Hospital, Shahrekord
Design
A clinical trial without a parallel control group, single blind, randomized
Settings and conduct
They are randomly assigned to one of the two cinnarizine or betahistine groups. At the beginning of the study, all clinical and neurological examinations will be performed. Detection of environmental attack vertigo based on the onset of a patient's transient dizziness that causes round-head circumference, auditory symptoms, and the creation of vertical-spin nystagmus in a Dix-Hallpike maneuver.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Aged 18-65 years; having vertigo symptoms for at least two months; drug hypersensitivity to cinnarizine and betahistine; normal vital signs and findings; normal nerve examination; lack of control of vertigo control drugs at least 7 days ago; no evidence of evidence Causes of central dizziness in CT scan performed by the patient before the study begins; Exclusion criteria: Patients with abnormal vital signs, kidney failure, liver disease, heart disease, active stomach ulcer disease or diabetes; patients with ulcerative diagnosis of vertigo with central causes; brain injury due to trauma: simultaneous use of blood pressure medications such as thiazide, antihistamine, Corticosteroids and calcium channel antagonists; Patients who have been treated with benzodiazepines for any reason; Patients who have received anti-vertigo during the last week; The sensitivity of the drug to cinnarizine and betahistine; those who are pregnant or breastfeeding; those who are satisfied with Do not study
Intervention groups
We have two intervention groups. One receives betahistine and the other group receives cinnarizine.
Main outcome variables
Number of vertigo attacks
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171030037093N16
Registration date:2019-07-14, 1398/04/23
Registration timing:prospective
Last update:2019-07-14, 1398/04/23
Update count:0
Registration date
2019-07-14, 1398/04/23
Registrant information
Name
Sadra Ansaripour
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3650 3487
Email address
st_ansari.s@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of cinnarizine and betahistine in the treatment of peripheral vertigo
Public title
The evaluation of the effect of cinnarizine and betahistine in the treatment of peripheral vertigo
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-65 years old
Having symptoms of vertigo for at least two months
Non-sensitivity to cinnarizine and betahistine
Natural Signs and Natural Nerve Findings
Failure to receive vertigo control drugs at least 7 days before
There is no evidence of the causes of central vertigo in a CT scan performed by a patient before the start of the study
Exclusion criteria:
Patients with abnormal vital signs, kidney failure, liver disease, heart disease, active stomach ulcer disease or diabetes
Patients with ulcerative diagnosis of vertigo with central causes
Brain traumatic brain injury
Concomitant use of hypertension drugs such as thiazide, antihistamines, corticosteroids and calcium channel antagonists.
Patients who are being treated for benzodiazepines for any reason
Patients who have received anti-vertigo during the last week
The sensitivity of the drug to cinnarizine and betahistine
Those who are pregnant or breastfeeding
People who are not satisfied with the study
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
170
Randomization (investigator's opinion)
Randomized
Randomization description
The drugs are given without any code tags, and the patient selects one of the two randomly by choosing the code.
Blinding (investigator's opinion)
Single blinded
Blinding description
The drugs are given without any code tags and the patient selects one of two drugs randomly by choosing the code, and the name of each person and the prescription drug code is recorded by the secretary and the patient is not informed about the type of medication.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
Vice chancellor for research, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713492
Approval date
2018-07-22, 1397/04/31
Ethics committee reference number
IR.SKUMS.REC.1397.137
Health conditions studied
1
Description of health condition studied
peripheral vertigo
ICD-10 code
H81.3
ICD-10 code description
Other peripheral vertigo
Primary outcomes
1
Description
Number of vertigo attacks
Timepoint
Patients will be asked one week after the start of the study and 8 weeks after the start of the study
Method of measurement
vertigo symptom scale questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first group receives 8 mg of betahistine three times a day
Category
Treatment - Drugs
2
Description
Intervention group: The second group received 25 mg of cinnarizine three times a day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Clinic
Full name of responsible person
Narges Maleki
Street address
Shariati Blvd., Imam Ali Clinic
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816788640
Phone
+98 38 3224 2696
Email
Dr.safari@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahrekord University of Medical Sciences
Full name of responsible person
Dr. seyed Kamal Solati(Associate Professor of Psychology)
Street address
Vice chancellor for research, Building No. 2, University headquarters, Ayatollah Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3334 2414
Email
kamal_solati@yahoo.com
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, Shahrekord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Mohammadhosein Saffari
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Shariati Blvd., Imam Ali Clinic
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816788640
Phone
+98 38 3224 2696
Email
Dr.safari@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Mohammadhosein Saffari
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Shariati Blvd., Imam Ali Clinic
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816788640
Phone
+98 38 3224 2696
Email
Dr.safari@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Mohammadhosein Saffari
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Shariati Blvd., Imam Ali Clinic
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816788640
Phone
+98 38 3224 2696
Email
Dr.safari@gmail.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
No - There is not 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information about the main outcome can be shared.
When the data will become available and for how long
Start the access period 4 months after publishing the results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Use data to complete clinical trial studies
From where data/document is obtainable
Imam Ali Clinic
What processes are involved for a request to access data/document
After the investigation of researcher request and presentation of required documents will be accessible.