Protocol summary

Summary
This study aims to compare the effectiveness of Epley maneuver and Cinnarizine in treatment of BPPV. In this randomized clinical trial patients with Benign Positional Paroxysmal Vertigo (BPPV) attending to vertigo clinic of Baqiyatallah hospital, Tehran, Iran in 2015 and 2016 will be assessed for eligibility. All patients will be informed of study process and possible side effects. A written informed consent will be obtained from all patients. Patients with definite diagnosis of BPPV, up to 2 days after diagnosis, and those who have not received any treatments for BPPV will be included. BPPV diagnosis will be made by single physician based on history taking and hallpike test. Patients with no definite diagnosis and those suspicious for other causes of vertigo, especially CNS involvement, will be excluded from the study. After being matched regarding age and gender, patients will be randomized to two groups: the first group (A) will undergo Epley repositioning maneuver by single physician and the second group (B) will use Cinnarizine (25mg every 8 hours) for two weeks. The block randomization will be accomplished by the clinic’s automatic turn system and patients were randomized into 2 groups at a ratio of 1:1 and a block size of 4. In the first visit, results of hallpike test will be recorded for both groups and after first Epley maneuver, group A patients will be recommended to place their head 45 degrees upper the body level during sleep for two days. The patients will be evaluated for symptoms using visual analogue scale (VAS) scoring system before intervention, first and second weeks after intervention. In the second and third visit, Epley maneuver was repeated in group A patients and the results of hallpike test was recorded for both groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016101717413N19
Registration date: 2016-10-28, 1395/08/07
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-10-28, 1395/08/07
Registrant information
Name
Hamidreza Karimi-Sari
Name of organization / entity
Student Research Committee, Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8126 4354
Email address
hrkarimisari@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of research of Baqiyatallah University of Medical Sciences
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Epley Maneuver and Cinnarizine in Treatment of Benign Positional Paroxysmal Vertigo
Public title
Comparison of Epley Maneuver and Cinnarizine in Treatment of Benign Positional Paroxysmal Vertigo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1- Patients with definite diagnosis of BPPV 2- only up to 2 days after diagnosis 3- those who have not received any treatments for BPPV Exclusion criteria: 1- Patients with no definite diagnosis 2- those suspicious for other causes of vertigo, especially CNS involvement 3- not willing to participate 4- previous history of treatment
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 40
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
Baqiyatallah University of Medical Sciences
Street address
Nosrati Alley, Sheykh Bahaei Street, Mollasadra street, Vanaq Square, Tehran, Iran
City
Tehran
Postal code
Approval date
2012-05-21, 1391/03/01
Ethics committee reference number
IR.BMSU.REC.1391.112

Health conditions studied

1

Description of health condition studied
Benign Positional Paroxysmal Vertigo
ICD-10 code
H81.1
ICD-10 code description
Benign paroxysmal vertigo

Primary outcomes

1

Description
Positional Paroxysmal Vertigo
Timepoint
Before, first and second week after intervention
Method of measurement
Halpike test

2

Description
Symptom Resolution
Timepoint
First and second weeks after intervention
Method of measurement
Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
The first group will undergo treatment with Epley Maneuver in the first visit and two more times in first and second weeks after intervention (three times in general)
Category
Treatment - Other

2

Description
The second group will undergo treatment with cinnarizine tablet (25 mg every 8 hours) for two weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqiyatallah Hospital
Full name of responsible person
Mohammad Hossein Khosravi
Street address
Baqiyatallah Hospital, Mollasadra st., Vanaq sq., Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Morteza Izadi
Street address
Baqiyatallah University of Medical Sciences, Nosrati Alley, Sheykh Bahaei st., Mollasadra st., Vanaq sq., 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
Baqiyatallah 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
Student Research Committee, Baqiyatallah University of Medical Sciences, Tehran, Iran
Full name of responsible person
Mohammad Hossein Khosravi
Position
Secretary-General
Other areas of specialty/work
Street address
Nosrati Alley, Sheykh Bahaei st, Mollasadra st., Vanaq sq., Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8862 0826
Fax
Email
dr.mhkhosravi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Otorhinolaryngology, Head and Neck Surgery, Faculty of Medicine, Baqiyatallah Universi
Full name of responsible person
Masoumeh Saeedi
Position
Otolaryngologist
Other areas of specialty/work
Street address
Nosrati Alley, Sheykh Bahaei st, Mollasadra st., Vanaq sq., Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8862 0826
Fax
Email
m.saeedi67@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Student Research Committee, Baqiyatallah University of medical sciences, Tehran, Iran.
Full name of responsible person
Mohammad Hossein Khosravi
Position
Secretary-General
Other areas of specialty/work
Street address
Nosrati Alley, Sheykh Bahaei st., Mollasadra st., Vanaq sq., Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8862 0826
Fax
Email
dr.mhkhosravi@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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