In this research, 30 eligible children patients with eczema and urticaria referring to allergist were chosen purposefully and a code was allocated to each one of them. Then, patients were serially go to study. Investigate before and after treatment.
Settings and conduct
this study do in Boalisina hospital with not blinding
Participants/Inclusion and exclusion criteria
Children between 3 to 6 months with eczema and urticaria. not use other antihistamines. not other disorders.
Intervention groups
All of patients use Cetirizine with dose of 0.25mg/kg.
Main outcome variables
Side effects and effect of drug
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110531006660N8
Registration date:2020-03-31, 1399/01/12
Registration timing:retrospective
Last update:2020-03-31, 1399/01/12
Update count:0
Registration date
2020-03-31, 1399/01/12
Registrant information
Name
Javad Ghafari
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3326 0054
Email address
ghafari@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of side effects of cetirizine syrup in infants 3-6 months with urticaria and atopic dermatitis
Public title
use of cetirizine in infants 3-6 months
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
infants with 3-6 months age;urticaria;eczema
Exclusion criteria:
sleep apnea in infant or another siblings
sensitivity to cetirizine
use of other antihistamines
QT interval more than 45 ms
Age
From 3 months old to 6 months old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of pharmaceutical science research center
Street address
Pharmaceutical faculty, Darya Road
City
Sari
Province
Mazandaran
Postal code
48471-93696
Approval date
2018-06-04, 1397/03/14
Ethics committee reference number
1815
Health conditions studied
1
Description of health condition studied
Cetirizine
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Clinical resolution of urticaria and eczema
Timepoint
Before and after 10 days treatment
Method of measurement
Visit and ECG
Secondary outcomes
1
Description
side effects of drug
Timepoint
10 days
Method of measurement
Visit and ECG
Intervention groups
1
Description
All of patients use cetirizine ( 0.25 mg/kg/day) for 10 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Boalisina Hospital
Full name of responsible person
Javad Ghaffari
Street address
Pasdaran Blvd
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3326 0053
Email
Javadneg@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Reza Alizadeh-Navaei
Street address
Moalem Sqaure
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3325 7230
Email
Reza_nava@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Javad Ghaffari
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Allergy
Street address
Boalisina Hospital
City
ُSari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3324 9804
Fax
Email
Javadneg@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Javad Ghaffari
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Allergy
Street address
Boalisina Hospital
City
ُSari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3324 9804
Fax
Email
Javadneg@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Javad Ghaffari
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Allergy
Street address
Boalisina hospital
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 3018
Email
Javadneg@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All of data shared except name`s of patients
When the data will become available and for how long
After one month
To whom data/document is available
All of people
Under which criteria data/document could be used
No limitation
From where data/document is obtainable
By email
What processes are involved for a request to access data/document