Comparison of the therapeutic effect of antihistamine with or without gluten-free diet in patients with urticaria
Design
Clinical trial with control group, with parallel groups, blinded, randomized, phase 3 on 90 patients. The rand function of Excel software was used for randomization.
Settings and conduct
This study is carried out after obtaining the code of ethics from Tehran Islamic Azad University of Medical Sciences in affiliated hospitals of this university. 90 samples of urticaria patients referred to the hospitals affiliated to this university who meet the study entry criteria will be selected based on random sampling. People's background information including gender, age, BMI and personal or family history of atopic diseases are collected through a pre-designed questionnaire, then patients are divided into two groups, placebo and case, according to gender, age, BMI and personal and family history of atopic diseases are divided, then the placebo group receives one vitamin B1 100mg daily and antihistamine for one month, and the case group receives gluten-free diet and antihistamine for one month and follow up the symptoms of both The group is evaluated on a weekly basis using the UAS7 form, the intensity of urticaria symptoms based on the amount of itching and the number of hives.
Participants/Inclusion and exclusion criteria
Patients referred to affiliated hospitals of Tehran Islamic Azad University of Medical Sciences
Patients with urticaria
The possibility of examining the patient's symptoms and the patient's cooperation
Intervention groups
Intervention group: antihistamine and gluten-free diet. Control group: antihistamine alone.
Main outcome variables
Urticaria severity (based on urticaria activity score: UAS)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230709058722N1
Registration date:2024-02-04, 1402/11/15
Registration timing:prospective
Last update:2024-02-04, 1402/11/15
Update count:0
Registration date
2024-02-04, 1402/11/15
Registrant information
Name
Farough Bazargani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 938 762 3971
Email address
faroughbazargani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-21, 1402/12/02
Expected recruitment end date
2024-03-21, 1403/01/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the therapeutic effect of antihistamine with or without gluten-free diet in patients with urticaria
Public title
The effect of gluten-free diet in the treatment of urticaria
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with urticaria
Exclusion criteria:
no possibility of examining the patient's symptoms
patient's unwillingness to cooperate in the study
Age
From 15 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random, every urticaria patient who comes to the hospital is placed in groups through a table of random numbers that have been determined in advance. Based on that, the numbers 1, 4, 7, and... in one group and the numbers 2, 3, 5, 6, 8, and 9... in the other group will be selected as random numbers, using simple random sampling method.
Blinding (investigator's opinion)
Not 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 Islamic Azad University, Tehran Medical Branch
Street address
Shariati St, Islamic Azad University, Tehran Medical Branch
City
Tehran
Province
Tehran
Postal code
1916893813
Approval date
2023-07-04, 1402/04/13
Ethics committee reference number
IR.IAU.TMU.REC.1402.075
Health conditions studied
1
Description of health condition studied
Chronic urticaria
ICD-10 code
L50
ICD-10 code description
Urticaria
Primary outcomes
1
Description
Urticaria severity (based on urticaria activity score: UAS)
Timepoint
At the beginning of the study (before the start of the intervention) and 7, 14 and 21 days after the start
Method of measurement
UAS7: Urticaria activity can be evaluated using the UAS7 scoring system. Urticaria/pruritus scores are accumulated daily for seven days. The maximum score is 42. Score 0: no hives for 24 hours Score 0: no itching Score 1: less than 20 hives in 24 hours Score 1: mild itching: present but not annoying or troublesome. Score 2: 20 to 50 hives during 24 hours Score 2: Moderate itching: It is troublesome but does not interfere with normal daily activities or sleep. Score 3: More than 50 hives during 24 hours Score 3: Severe itching: Severe itching, as much as which interferes with normal daily activities or sleep
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 90 samples of urticaria patients referred to the hospitals of this university who meet the inclusion criteria will be selected based on the random sampling method. The patients will be divided into two groups: placebo and case. Antihistamine for one month and following up the symptoms of both groups on a weekly basis using the UAS7 form, the intensity of urticaria symptoms is scored and evaluated based on the amount of itching and the number of hives.
Category
Treatment - Other
2
Description
Control group: A number of 90 samples of urticaria patients referred to the hospitals affiliated to this university who meet the criteria for entering the study will be selected based on the random sampling method. 100 mg daily and antihistamine for one month are investigated.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Farhikhtegan Hospital
Full name of responsible person
Dr. Setareh Tehrani
Street address
Farhikhtegan Hospital Shahran, Tehran Tehran Province Iran
City
Tehran
Province
Tehran
Postal code
1477899679
Phone
+98 21 4484 5163
Email
farhikhteganhospital@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mehrdad gholamzade
Street address
Shariati St, Islamic Azad University, Tehran Medical Branch
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Email
shahabpour_golaleh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Setareh Tehrani
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
Plate 9 Unit 4, Ramzan Khavarani St., Mohsen Om, Zargandehrani St.
City
Tehran
Province
Tehran
Postal code
1916695464
Phone
+98 21 2260 7495
Email
tehrani۲۴۹@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Setareh Tehrani
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Dermatology
Street address
Plate 9 Unit 4, Ramzan Khavarani St., Mohsen Om, Zargandehrani St.
City
Tehran
Province
Tehran
Postal code
1916695464
Phone
+98 21 2260 7495
Email
tehrani۲۴۹@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farough Bazargani
Position
medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Plate 9 Unit 4, Ramzan Khavarani St., Mohsen Om, Zargandehrani St.
City
Tehran
Province
Tehran
Postal code
1916695464
Phone
+98 21 2260 7495
Email
faroughbazargani@gmail.com
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