(1) Objectives: Comparing the efficacy of intravenous hyoscine and diazepam for management of true peripheral vertigo
(2) Design: This study is a double blind randomized clinical trial.
(3) Setting and conduct: Patients with diagnosis of true peripheral vertigo were randomly divided into two groups treated with intravenous hyoscine (intervention) and intravenous diazepam (control).
(4) Participants: 52 patients with moderate to severe vertigo compatible with clinical diagnosis of true peripheral vertigo and have no contraindications for administration of hyoscine and diazepam
(5) Intervention: 5 mg hyoscine in intervention group and 10 mg diazepam in control group was slow intravenously administered.
(6) Main outcome measures: Severity of vertigo was assessed before drug administration and also 1 and 2 hours after will be recorded. Management success (decreasing 1 score of vertigo), vertigo relief and side effects were assessed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016100815640N5
Registration date:2016-10-10, 1395/07/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-10-10, 1395/07/19
Registrant information
Name
Alireza Baratloo
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6312 0432
Email address
alirezabaratloo@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2016-09-21, 1395/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of hyoscine and diazepam in management of true peripheral vertigo
Public title
Comparing the effect of hyoscine and diazepam in management of true peripheral vertigo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 18-60 years old patients with clinical diagnosis of true peripheral vertigo
Exclusion criteria: History of vertigo mitigation prophylaxis, allergy to hyoscine or diazepam, pregnancy, renal failure, breast feeding, recurrent vertigo
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization using randomized number table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Shahid Beheshti University of Medical Sciences
Street address
Vice chancellor for research, Shahid Beheshti University of Medical Sciences, Velenjak Street
City
Tehran
Postal code
Approval date
2016-01-26, 1394/11/06
Ethics committee reference number
IR.SBMU.MSP.REC.1394.134
Health conditions studied
1
Description of health condition studied
True peripheral vertigo
ICD-10 code
H81.3
ICD-10 code description
Other peripheral vertigo
Primary outcomes
1
Description
Severity of vertigo
Timepoint
before drug administration and also 1 and 2 hours after that
Method of measurement
Verbal quantitative scale
Secondary outcomes
1
Description
side effects
Timepoint
from starting drug administration until 2 hours after
Method of measurement
Serial physical exam
Intervention groups
1
Description
administration of 5 mg hyoscine slow intravenously (intervention)
Category
Treatment - Drugs
2
Description
administration of 10 mg diazepam slow intravenously (control)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hosein Hospital
Full name of responsible person
Dr. Hamid Kariman
Street address
Shahid Madani Street
City
Tehran
2
Recruitment center
Name of recruitment center
Shohadaye Tajrish Hospital
Full name of responsible person
Dr. Alireza Baratloo
Street address
Tajrish Square
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Ali Ziyayi
Street address
Vice chancellor for research, 3rd floor, Medical School, Shahid Beheshti University of Medical Sciences, Velenjak, Tehran, Iran
City
Tehran
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, Shahid Beheshti University of Medical Sciences