This is a non-blinded randomized clinical trial to compare oral betahistine and piracetam for treating outpatient vertigo patients. Patients with acute vertigo who are discharged from the emergency department will be included in the study. Patient who are below 18, are using other drugs that can improve vertigo, have prior history of sensitivity to each of two drugs, peptic ulcer disease, or pheochromocytoma, or are not consent to participate in the study will be excluded of this study. Target population for this study are patients with acute vertigo that are discharged from the emergency department. Sample size for this study is 96 (48 patients in each group). Patients will be randomly assigned to one of two groups (betahistine or piracetam group). Betahistine will be given 8 milligrams every eight hours and piracetam will be given 800 milligrams every eight hours. Both betahistin and piracetam will be given for seven days. Primary outcome is vertigo intensity after seven days. Secondary outcomes are nausea and fatigue intensity and adverse effects in two groups after seven days.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016011921063N3
Registration date:2016-08-28, 1395/06/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-08-28, 1395/06/07
Registrant information
Name
Arash Safaie
Name of organization / entity
Tehran University of Medical Scieces- Sina Hospital
Country
Iran (Islamic Republic of)
Phone
+98 216312413
Email address
a-safaie@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2015-09-01, 1394/06/10
Expected recruitment end date
2017-01-01, 1395/10/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of oral piracetam and oral batahistine in treatment of acute vertigo in emergency department patients
Public title
Comparison of oral piracetam and oral batahistine in treatment of acute vertigo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with acute vertigo who are discharged from the ED.
Exclusion criteria:
Age <18 years ; Prior sensitivity to piracetam or betahistin ; Using other drugs that potentially improve vertigo (antihistamines, anticholinergics, bezodiazepines, ...) ; Peptic ulcer disease history ; Pheochromoytoma disease ; Patients who are not consent to participate in the study
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences ethical committee
Street address
Shahid Abbas Arabi street, Yemen Street, Shahid Chamran Highway
City
Tehran
Postal code
Approval date
2015-08-25, 1394/06/03
Ethics committee reference number
IR.SBMU.SM.REC.1394.25
Health conditions studied
1
Description of health condition studied
Disorders of vestibular function
ICD-10 code
H81
ICD-10 code description
Disorders of vestibular function
Primary outcomes
1
Description
Vertigo severity
Timepoint
7 days after treatment
Method of measurement
NRS
Secondary outcomes
1
Description
Nausea intensity
Timepoint
7 days after treatment
Method of measurement
NRS
2
Description
Fatigue intensity
Timepoint
7 days after treatment
Method of measurement
NRS
3
Description
Adverse events
Timepoint
7 days after treatment
Method of measurement
Adverse event name
Intervention groups
1
Description
Piracetam 800 mg TDS PO
Category
Treatment - Drugs
2
Description
Betahistin 8 mg TDS PO
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Hossein Hospital
Full name of responsible person
Dr Ali Arhami Dolatabadi
Street address
Emergency Department, Emam Hossein Hospital, Shahid Madani street
City
Tehran
2
Recruitment center
Name of recruitment center
Shohada Tajrish Hospital
Full name of responsible person
Dr Saeed Safari
Street address
Tajrish square
City
Tehran
3
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr Arash Safaie
Street address
Emergency Department, Sina Hospital, Hassan Abad square
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zarghi
Street address
Shahid Abbas Arabi street, Yemen Street, Shahid Chamran Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Ali Arhami Dolatabadi
Position
Associate professor of emergency medicine
Other areas of specialty/work
Street address
Emergency Department, Emam Hossein Hospital, Shahid Madani street
City
Tehran
Postal code
Phone
+98 21 7343 2380
Fax
Email
aliarhami@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Ali Arhami Dolatabadi
Position
Associate professor of emergency medicine
Other areas of specialty/work
Street address
Emergency Department, Emam Hossein Hospital, Shahid Madani street
City
Tehran
Postal code
Phone
+98 21 7343 2380
Fax
Email
aliarhami@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Arash Safaie
Position
Assistant professor of emergency medicine
Other areas of specialty/work
Street address
Emergency Department, Sina Hospital, Hassan Abad square
City
Tehran
Postal code
Phone
+98 216312413
Fax
Email
a-safaie@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)