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IRCT20231126060193N1 IRCT 2024-01-12 Shiraz University of Medical Sciences The Role of Intranasal Corticosteroids in the Management of Chronic Idiopathic Urticaria with Positive Skin Prick Test to Airborne Allergens The effect of intranasal corticosteroids in adults with chronic idiopathic urticaria with a positive prick test with airborne allergens. 2023-11-08 anticipated 69 Complete https://irct.ir/trial/74837 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The participants in this study will include adult patients aged 18 years and older who have been diagnosed with idiopathic urticaria based on clinical criteria and have tested positive for air allergens in the prick test. Participants will be randomly selected from adult allergy clinics using simple random sampling) . Patients are divided into two intervention and placebo groups by researchers using sealed envelopes that cannot be seen in light. . Informed consent will be obtained from the participants, Blinding description: Using computer randomization codes, participants will be randomly assigned to two intervention groups or control groups. Allocation is concealed from researchers, participants, and their families to ensure blinding. A placebo intranasal spray will be provided to the control group to maintain blinding for the duration of the study. 3 Chronic Idiopathic Urticaria. Intervention 1: Intervention group: The intervention group will be treated with Nasal Budesonide (with a dose of 32 micrograms per spray) twice a day. The specific corticosteroid and dose will be determined based on previous studies and standard clinical practice. Participants in this group will be instructed on the correct method of administration and compliance will be monitored throughout the study period. Intervention 2: Control group: The control group receives a 0.9% sodium chloride intranasal spray, which is very similar to the active treatment but does not contain any active corticosteroids. Placebo spray is administered according to the same schedule and instructions as the intervention group. Yes - There is a plan to make this available What will be shared: All data can be shared after de-identifying individuals. When: The access period starts 6 months after the results are published To whom: Only researchers working in academic and scientific institutions Conditions: There is no special condition, with the permission of the corresponding author, people can use the data in any way they need. Where to obtain: To the corresponding author Dr. Hossein Esmailzadeh at the email address: esmailzadeh_ho@yahoo.com How to obtain: After checking the identification documents and how to use them according to the applicant proposal . The corresponding author will send the data to the individual (about three months). Comments:
public Hossein Esmaeilzadeh
Zand
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3230 5410 esmailzadeh_ho@yahoo.com Shiraz University of Medical Sciences scientific Hossein Esmaeeilzade
Zand
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3230 5410 esmailzadeh_ho@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Inclusion Criteria:Patients must be older than eighteen years.Patients must have a diagnosis of idiopathic urticaria and positive prick test results for airborne antigens.Patients should be selected from adult allergy clinics.Patients must give their informed consent to participate in the study. 18 years no limit Both Exclusion criteria:Patients who are under treatment other than antihistamines by a doctor specializing in asthma and allergies.Patients who cannot participate during six months.Patients who had serious side effects due to corticosteroids before the start of the study.Patients who have serious side effects caused by the use of corticosteroids during the study period.Patients who experience serious side effects from corticosteroids during the study period. L50.1 Idiopathic urticaria Treatment - Drugs Treatment - Drugs Intervention group: The intervention group will be treated with Nasal Budesonide (with a dose of 32 micrograms per spray) twice a day. The specific corticosteroid and dose will be determined based on previous studies and standard clinical practice. Participants in this group will be instructed on the correct method of administration and compliance will be monitored throughout the study period. Control group: The control group receives a 0.9% sodium chloride intranasal spray, which is very similar to the active treatment but does not contain any active corticosteroids. Placebo spray is administered according to the same schedule and instructions as the intervention group. Primary outcome measures include the frequency and severity of urticaria symptoms, which are evaluated using valid scoring systems such as the Urticaria Activity Score and the Urticaria Severity Score. Timepoint: At the beginning of the study (before the start of the intervention) and six months after the start of the study. Method of measurement: Quality of life questionnaire related to chronic urticaria. Shiraz University of Medical Sciences Approved 2023-11-07 Ethics committee of Shiraz University of Medical Sciences Zand st Shiraz Fars Iran (Islamic Republic of)