Comparison of vestibular rehabilitation methods and the use of serotonin norepinephrine reuptake inhibitors (venlafaxine) in the treatment of patients with persistent postural perceptual dizziness.
Clinical trial with a control group, with parallel groups, without blinding, randomized, phase 2 on 60 patients. A table of random numbers was used for randomization.
Settings and conduct
This study will be conducted on people with persistent situational perceptual dizziness in 1402 in Isfahan city. Participants will participate in two treatment groups: venlafaxine or vestibular rehabilitation. Blinding was not done in this study.
Participants/Inclusion and exclusion criteria
People with a diagnosis of persistent perceptual dizziness who have informed consent to participate in the study and do not have an underlying disease that affects the results.
Intervention groups
The group treated with venlafaxine and the group treated with vestibular rehabilitation
Main outcome variables
dizziness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230803059017N1
Registration date:2023-08-07, 1402/05/16
Registration timing:prospective
Last update:2023-08-07, 1402/05/16
Update count:0
Registration date
2023-08-07, 1402/05/16
Registrant information
Name
Niloofar Tarbiat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 937 523 4838
Email address
niloofar.tarbiat@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2023-09-23, 1402/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of vestibular rehabilitation methods and the use of serotonin norepinephrine reuptake inhibitors (venlafaxine) in the treatment of patients with persistent postural perceptual dizziness.
Public title
rehabilitation methods and the use of serotonin norepinephrine reuptake inhibitors (venlafaxine) in the treatment of patients with persistent postural perceptual dizziness
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Comparison of two vestibular rehabilitation methods and the use of serotonin norepinephrine reuptake inhibitors (venlafaxine) in the treatment of patients with persistent postural perceptual dizziness.
Age over 18 years and under 65 years
Informed consent to participate in the study
Dizziness Handicap Inventory (DHI) >16
Exclusion criteria:
Having psychiatric and/or cognitive disorders that prevent understanding tests and questionnaires.
Using drugs that cause dizziness
Having brain structural disorders
Having high blood pressure
Having a history of heart disease such as heart failure and heart attack
hyperthyroidism
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
First, with the help of a random number table, a number of random numbers were generated according to the sample size, and then they were placed in sealed envelopes in this order and numbered on the envelopes. Then, according to the order in which the participants entered the study, an envelope is opened and a random sequence is determined.
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
Ethics committee of IsfahanUniversity of Medical Sciences
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-07-30, 1402/05/08
Ethics committee reference number
IR.MUI.MED.REC.1402.169
Health conditions studied
1
Description of health condition studied
Persistent postural perceptual dizziness
ICD-10 code
R42
ICD-10 code description
Dizziness and giddiness
Primary outcomes
1
Description
dizziness
Timepoint
before and after treatment (6 weeks later)
Method of measurement
dizziness handicap inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Treatment with venlafaxine dose 37.5 made by Hakim Pharmaceutical Company once a day for 6 weeks.
Category
Treatment - Drugs
2
Description
Intervention group: vestibular rehabilitation once weekly for 6 weeks
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani hospital
Full name of responsible person
Niloofar Tarbiat
Street address
Kashani street
City
Isfahan
Province
Isfehan
Postal code
8974673461
Phone
+98 937 523 4838
Email
niloofar.tarbiat@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholareza Asgari
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8974673461
Phone
+98 31 3668 8138
Email
askari@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Niloofar Tarbiat
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 937 523 4838
Email
niloofar.tarbiat@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Niloofar Tarbiat
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 937 523 4838
Email
niloofar.tarbiat@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Niloofar Tarbiat
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 937 523 4838
Email
niloofar.tarbiat@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD