The aim of this study is to compare the efficacy of Atorvastatin in chronic idiopathic utricaria. A total of forty seven patients between 15 to 45 years old are enrolled into the study. The patients are assigned into one of the following groups. The patients in the first group receive one Atorvastatin tablet (40 mg/Kg) and antihistamine every 12 hours and in the second group receive one placebo tablet and antihistamine every 12 hours for 3 months. Changes in autologus test and utricaria severity score are measured at the baseline and the end of treatment and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110033862N8
Registration date:2011-10-17, 1390/07/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-10-17, 1390/07/25
Registrant information
Name
Farahzad Jababri Azad
Name of organization / entity
Mashahd University of Medical Scineces
Country
Iran (Islamic Republic of)
Phone
+98 51 1843 6626
Email address
banihashemim@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Council of Mashhad University of Medical Sciences
Expected recruitment start date
2010-10-21, 1389/07/29
Expected recruitment end date
2011-11-20, 1390/08/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Therapeutic efficacy of atorvastatin in chronic idiopathic utricaria
Public title
Therapeutic efficacy of atorvastatin in chronic idiopathic utricaria
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: presence of utricaria more than 8 weeks, Normality of thyroids assay test, Negativity of antithyroglobulin, antimicrosomal antibodies and skin prick test for inhale and oral common allergens
Exclusion criteria: Addiction, Systemic and chronic diseases, Pregnancy
Age
From 15 years old to 45 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
66
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
Ethics Committee of Mashhad University of Medical Sciences
Street address
Central Building of Mashad University of Medical Sciences
City
Mashhad
Postal code
Approval date
2009-08-09, 1388/05/18
Ethics committee reference number
87921
Health conditions studied
1
Description of health condition studied
Idiopathic urticaria
ICD-10 code
L50.1
ICD-10 code description
Idiopathic urticaria
Primary outcomes
1
Description
utricaria severity
Timepoint
Baseline and at the end of treatment course
Method of measurement
Utricaria severity is calculated according to Breneman et al to 4 categories; Mild, Moderate and sever
Secondary outcomes
1
Description
Cytokines Variations
Timepoint
baseline and after the treatment course
Method of measurement
Measuring selective cytokines by Eliza method in lymphocyte culture
Intervention groups
1
Description
one tablet Atorvastatin (40mg/Kg) every 12 hours (twice daily) in patient group until 3 month.
Category
Treatment - Drugs
2
Description
one tablet placebo every 12 hours (twice daily) until 3month in control group
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Allergy Reserach Center, Ghaem Hospital, Mashhad University of Medical Sciences
Full name of responsible person
Dr Reza Faridhosseini, Dr Pezeshkpoor,Dr Farahzad Jabbari, Dr Behzad Shakerian, Dr Rafatpanah
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Council of Mashhad University of Medical Sciences
Full name of responsible person
Vice chancellor for research of Mashhad University of Medical Sciences, Dr Jalil Tavakol Afshari
Street address
Central Building of Mashhad University of Medical Sciences
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Council of Mashhad 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
Allergy Research Center, Mashahd University of Medical Sciences
Full name of responsible person
Dr Farahzad Jabbari
Position
Assistant Professor of Allergy and Clinical Immunogy
Other areas of specialty/work
Street address
Allergy research Center, Ghaem Hospital
City
Mashahd
Postal code
Phone
+98 51 1843 6626
Fax
Email
arc@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Allergy Reseach Center, Mashhad University of Medical Sciences
Full name of responsible person
Dr Farahzad Jabbari
Position
Assistant Professor of Allergy and Clinical Immunology
Other areas of specialty/work
Street address
Allergy Reseach Center, Ghaem Hospital
City
Mashhad
Postal code
Phone
+98 51 1843 6626
Fax
Email
jabbarif@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Allergy Reseach Center
Full name of responsible person
Hadis Yousefzadeh
Position
Reseach Assistant
Other areas of specialty/work
Street address
Allergy Reseach Center, Ghaem Hospital
City
Mashahd
Postal code
Phone
Fax
Email
arc@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)