Hydroxyzine is a first-generation antihistamine of the diphenylmethane and piperazine class. Due to its antagonistic effects on several receptor systems in the brain, hydroxyzine is claimed to have strong anxiolytic and mild antiobsessive as well as antipsychotic properties. Studies of heart rate variability (HRV) present a noninvasive, simple, and quantitative tool of evaluating autonomic performance on the heart. In this study, we intend to assess the effects of acute oral Hydroxyzine on heart rate variability (HRV). The Hydroxyzine (doses of 5, 10 and 20 mg) or placebo administer in four different testing sessions. The 15 healthy subjects would included in the study. In ever session, power spectral analysis of HRV parameters will assess in the supine position before and after the participants were given placebo or different doses of Hydroxyzine.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014051611236N5
Registration date:2014-05-26, 1393/03/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-05-26, 1393/03/05
Registrant information
Name
Esmaeil Akbari
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 12 1223 0855
Email address
akbari_esmaeil@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy for Research, Mazandaran University of Medical Sciences
Expected recruitment start date
2014-05-20, 1393/02/30
Expected recruitment end date
2015-01-20, 1393/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Cardiac autonomic system responses to oral administration of Hydroxyzine hydrochloride in male healthy subjects.
Public title
Effect of oral Hydroxyzine on heart rate variability
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: male; ages between 19-24 years old. Exclusion criteria: chronic disease (i.e. diabetes mellitus, hypertension, epilepsy and etc); smoker; under regular medication .
Age
From 19 years old to 24 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran University of Medical Sciences
Street address
Deputy for Research, Moalem Square, Buil. No 2, Mazandaran University of Medical Sciences, Sari, Iran.
City
Sari
Postal code
Approval date
2013-11-23, 1392/09/02
Ethics committee reference number
91198
Health conditions studied
1
Description of health condition studied
Healthy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
mean of RR interval
Timepoint
before and after administration of placebo or drug
Method of measurement
Time domain analysis of ECG
Secondary outcomes
1
Description
Standard deviation of RR interval
Timepoint
before and after administration of placebo or drug
Method of measurement
Time domain analysis of ECG
2
Description
High frequency power spectrum
Timepoint
before and after administration of placebo or drug
Method of measurement
Frequency domain analysis of ECG
Intervention groups
1
Description
Oral administration of 10 mg Hydroxyzine
Category
Treatment - Drugs
2
Description
Oral administration of 5 mg Hydroxyzine
Category
Treatment - Drugs
3
Description
Oral administration of placebo.
Category
Placebo
4
Description
Oral administration of 20 mg Hydroxyzine
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Medical Sciences of mazandaran University
Full name of responsible person
Street address
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy for Research, Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad-ali Enayati
Street address
Deputy for Research, Moalem Square, Buil. No 2, Mazandaran University of Medical Sciences, Sari, Iran. Sari Mazandaran
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy for Research, Mazandaran 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Physiology, School of Medicine, Mazandaran University of Medical Sciences, Sari
Full name of responsible person
Esmaeil Akbari
Position
Ph.D
Other areas of specialty/work
Street address
Department of Physiology, School of Medicine, Mazandaran University of Medical Sciences, Sari, Iran
City
Sari
Postal code
Phone
+98 15 1354 3081
Fax
Email
Akbari_esmaeil@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Physiology, School of Medicine, Mazandaran University of Medical Sciences, Sari
Full name of responsible person
Esmaeil Akbari
Position
Ph.D
Other areas of specialty/work
Street address
Department of Physiology, School of Medicine, Mazandaran University of Medical Sciences, Sari, Iran
City
Sari
Postal code
Phone
+98 15 1354 3081
Fax
Email
Akbari_esmaeil@mazums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)