The purpose of this study is to determine the efficacy of Dimenhydrinate after maneuver therapy of Epley on duration, number of vertigo attacks and duration of dizziness after each vertigo attack in patients with Posterior canal BPPV. One hundred forty eight patients with posterior Canal BPPV were evaluated in a randomized clinical trial in 2008 _2009. Maneuver therapy of Epley were done for all patients. Then, the patients were assigned to receive Dimenhydrinate or Placebo as well 2 weeks. Duration of vertigo (in days), number of vertigo attacks, and duration of dizziness after each vertigo attack (in minutes) were measured before and after the treatment and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138905032893N2
Registration date:2010-12-22, 1389/10/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-12-22, 1389/10/01
Registrant information
Name
Poopak Izadi
Name of organization / entity
Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 8896 9437
Email address
izadi@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahed University
Expected recruitment start date
2008-03-20, 1387/01/01
Expected recruitment end date
2010-03-20, 1388/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of dimenhydrinate on Benign Paroxysmal Positional Vertigo after maneuver therapy of Epley
Public title
Evaluation of the effect of dimenhydrinate on Benign Paroxysmal Positional Vertigo after maneuver therapy of Epley
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: individuals with posterior canal BPPV, confirmed with Dix_Hallpike positional test with classical signs of vertigo and nystagmus
Exclusion criteria: lateral or superior semicircular canal involvement, CNS abnormality, bilateral posterior semicircular canal involvement, physical disability, history of vestibular suppressant usage, other labyrinthine diseases
Age
No age limit
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
148
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahed University
Street address
Against holy shrine of Imam Khomeini, Tehran Qom highway,
City
Tehran
Postal code
Approval date
2009-12-22, 1388/10/01
Ethics committee reference number
64270
Health conditions studied
1
Description of health condition studied
Benign Paroxysmal Positional Vertigo
ICD-10 code
H60, H95,
ICD-10 code description
Otitis externa, Postprocedural disorders of ear and mastoid process, not elsewhere classified, Benign paroxysmal vertigo
Primary outcomes
1
Description
recovery of vertigo
Timepoint
daily
Method of measurement
history, Hallpike test
Secondary outcomes
empty
Intervention groups
1
Description
Dimenhydrinate, 50 mg, TDS, for 2 weeks
Category
Treatment - Drugs
2
Description
Placebo, TDS, for 2 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mostafa Khomeini Hospital
Full name of responsible person
Poopak Izadi
Street address
Italia Ave., Keshavarz Blvd.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Poopak Izadi
Street address
Against Holy shrine of Imam Khomeini, Qom highway, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
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 Mostafa Khomeini hospital, Shahed University