Determining the difference in the effectiveness of Cetirizine and Desloratadine on quality of life and clinical symptoms in CSU patients (resistant to AntiH2)
-Comparison of the effects of two drugs in reducing the symptoms of CSU patients
-Comparison of the effects of two drugs, on the quality of life of CSU patients
Design
A clinical trial with the control group, with parallel groups, randomized, on 180 patients. Blocked randomization. Cards that identify the intervention and control group are prepared using the Stata software and 4, 6, and 8 size blocks for concealment.
Settings and conduct
This study aims to compare two drugs, Cetirizine and Desloratadine, on patients referred to the Allergy and Immunology Department of Ghaem Mashhad Hospital.
After obtaining informed consent, the characteristics of the patients are measured through a questionnaire at the beginning and two weeks later.
During this, patients in two separate groups are treated with cetirizine and Desloratadine (4 times the standard dose).
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Age 18 to 65 years old
2. History of spontaneous chronic urticaria for a period of at least six weeks during the last three months
3. Failure to respond to usual doses of second-generation antihistamines
4. Lack of disease control based on the score of the UCT questionnaire
Exclusion criteria:
1. Pregnancy
3. History of other types of urticaria and hereditary angioedema.
Intervention groups
Intervention group 1: 90 eligible patients are treated with 4 times the standard therapeutic dose of cetirizine for 2 weeks.
Intervention group 2: 90 eligible patients are treated with 4 times the standard therapeutic dose of desloratadine for 2 weeks.
Main outcome variables
Changes in quality of life, pruritus and urticaria based on a questionnaire (CU-QoL) and UCT
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211219053449N1
Registration date:2022-10-16, 1401/07/24
Registration timing:prospective
Last update:2022-10-16, 1401/07/24
Update count:0
Registration date
2022-10-16, 1401/07/24
Registrant information
Name
Elahe Moradzade
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 0884
Email address
moradzadehe991@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-23, 1401/08/01
Expected recruitment end date
2023-03-22, 1402/01/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of Cetirizine and Desloratadine on the symptoms of chronic spontaneous urticarial and quality of life
Public title
Comparison of the effects of Cetirizine and Desloratadine on the symptoms of chronic spontaneous urticarial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The purpose of the study will be explained to all patients and written informed consent will be obtained.
CSU patients with a history of chronic spontaneous urticaria for at least six weeks during the last three months
who did not respond to standard doses of second-generation antihistamines
the illness was not controlled according to the disease questionnaire.
Blocked randomization. Using software and 4, 6 and 8 size blocks for hiding, the cards that identify the intervention and control group are prepared and then placed in opaque envelopes and the envelopes are arranged and numbered according to the sequence produced by the software and the patients are arranged accordingly. Admission (envelope number one for the first patient and two for the second, etc.) are assigned to the intervention or comparison group according to the card in the envelope.
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
Research Ethics Committees of School of Medicine- Mashhad University of Medical Sciences
Street address
university street
City
mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2022-05-31, 1401/03/10
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1401.163
Health conditions studied
1
Description of health condition studied
Chronic urticaria
ICD-10 code
L50
ICD-10 code description
Urticaria
Primary outcomes
1
Description
UCT questionnaire score: assessment of pruritus and urticaria symptoms
Timepoint
before and after 14 days of taking the drug
Method of measurement
UCT questionnaire
2
Description
CU-QoL questionnaire: assessment of quality of life
Timepoint
At the beginning of the study and 2 weeks after taking the drug
Method of measurement
Chronic Urticaria-Quality of Life Questionnaire (CU-QoL)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: prescription of cetirizine tablets from Abidi pharmaceutical company in 4 times the standard dose for 2 weeks
Category
Treatment - Drugs
2
Description
Intervention group 2: Administration of Desloratadine tablets from Abidi pharmaceutical company in 4 times the standard dose for 2 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Allergy and Immunology Department of Ghaem Hospital
Full name of responsible person
Maryam Khoshkhui
Street address
Ahmadabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 915 306 4631
Email
moradzadehe991@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
majid Ghayour mobarhan
Street address
daneshgah str.
City
mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
GhayourM@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Dr. Abidi Pharmaceuticals
Proportion provided by this source
50
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
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Khoshkhui
Position
assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Allergy and clinical immunology
Street address
daneshgah str.
City
mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3840 0000
Email
KhoshkhuiM@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
maryam Khoshkhui
Position
assiatant proff.
Latest degree
Subspecialist
Other areas of specialty/work
Allergy and clinical immunology
Street address
daneshgah str.
City
mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3840 0000
Email
KhoshkhuiM@mums.ac.i
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
maryam Khoshkhui
Position
assistant proff.
Latest degree
Subspecialist
Other areas of specialty/work
Allergy and clinical immunology
Street address
daneshgah str.
City
mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3840 0000
Email
KhoshkhuiM@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available