The Goal of this open clinical trial is to evaluate the effect of Mesalazine on Chronic Idiopathic Urticaria.
30 patients are selected randomly.
The patients include new cases and resistant cases to Antihistamines.
We exclude children under 12 years old, pregnant and breastfeeding mothers, those with sensitivity to this medication and those with underlying problems.
After performing CBC, LFT, BUN, Cr, Stool Exam and TFT, Mesalazine 500 mg Bid is administered to the patients and they would be followed after 15 and 60 days.
The primary outcome is decrease in symptoms and improvement in quality of life of the patients according to the indices recorded.
If any improvement observed in first 15 days of treatment, the drug would be discontinued.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138710041520N1
Registration date:2009-04-03, 1388/01/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2009-04-03, 1388/01/14
Registrant information
Name
Alireza Abdollahee
Name of organization / entity
Shiraz University Of Medical Sciences , Dermatology Department
Country
Iran (Islamic Republic of)
Phone
+98 71 1731 3244
Email address
abdolaha@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research of Shiraz University of Medical Sciences
Expected recruitment start date
2008-06-26, 1387/04/06
Expected recruitment end date
2009-05-22, 1388/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the therapeutic effects of Mesalazine in patients with chronic idiopathic urticaria
Public title
Mesalazine in chronic idiopathic urticaria
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: new cases, the patients without proper control with antihistamines
Exclusion Criteria : children under 12y, pregnant ladies or women with breast feeding, underlying diseases, 5-ASA sensitivity, G6PD deficiency
Age
From 12 years old to 75 years old
Gender
Both
Phase
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
30 patients with chronic idiopathic urticaria for more than 6 weeks, without any etiologic finding in lab tests and examinations , include in the research.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University Of medical sciences
Street address
Central Building of Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Postal code
Approval date
2008-06-24, 1387/04/04
Ethics committee reference number
2954
Health conditions studied
1
Description of health condition studied
Chronic Idiopathic urticaria
ICD-10 code
L50.1
ICD-10 code description
Idiopathic Urticaria
Primary outcomes
1
Description
Decrease in Symptoms of the patients
Timepoint
15 dayas and 1 month and 2 month
Method of measurement
Symptom Severity indices and Quality of Life Questionaire
Secondary outcomes
1
Description
Improvement in Quality of Life of the patients
Timepoint
2 month
Method of measurement
Quality of life Questionaire
Intervention groups
1
Description
Mesalazine 500 mg Bid for 2 months
Category
empty
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology Clinics - Shiraz Faghihi Hospital
Full name of responsible person
Street address
City
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences - Vice Chancellor for Research Affairs
Full name of responsible person
Dr. Mohammad Hosein Dabaghmanesh
Street address
Central Bulding Of Shiraz University Of Medical Sciences- Vice Chancellor for Research Affairs - Zand Street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences - Vice Chancellor for Research Affairs
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
Shiraz University of Medical Sciences
Full name of responsible person
Alireza Abdollahee
Position
Resident of Dermatology
Other areas of specialty/work
Street address
no14-Alley24-Fazilat
City
Shiraz
Postal code
Phone
+98 71 1730 3431
Fax
Email
abdolaha@sums.ac.ir & alireza2358@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ladan Dastgheib
Position
Associate Professor of Shiraz University of Medical Sciences
Other areas of specialty/work
Street address
Shihid Faghihi Dermatology Clinic
City
Shiraz
Postal code
Phone
+98 71 1731 3244
Fax
Email
dastgl@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)