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IRCT20231016059741N1 IRCT 2023-11-06 Oroumia University of Medical Sciences Comparison between nasal mucosiliary clearance in children with moderate to severe allergic rhinitis in two groups treated with or without normal saline irrigation Comparison between nasal mucosiliary clearance in children with moderate to severe allergic rhinitis in two groups treated with or without normal saline irrigation 2023-09-23 anticipated 108 Complete https://irct.ir/trial/73272 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: The randomization will be by the block randomization method,so that first the blocks will be listed in the size of 6 of combination(AAABBB) and a code will be assigned to each one, and then according to the sample size (108) and Blocks(6) in the number of 17 blocks will be selected using simple randomization method.All this process will be done using Random Allocation Software under the supervision of an epidemiologist. N/A Allergic rhinitis. Intervention 1: Intervention group:Nasal cleansing test will be measured before and 4 weeks after nasal washing in all patients. 54 children will be taught to wash their nose regularly 3 times a day with normal saline solution for 6 weeks .Also , the patients will be treated with oral antihistamine drugs , and the amount of antihistamine drug consumption will be collected at the end of each week. Intervention 2: Control group:Nasal cleansing test will be measured before and 4 weeks after nasal washing in all patients.54 patients will not wash their nose with normal saline.Also , the patients of will be treated with oral antihistamine drugs, and the amount of antihistamine drug consumption will be collected at the end of each week. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals. When: Begining of the access period 6 months after the publication of the study results(since 1403) To whom: The data will be accessible to everyone. Conditions: The data will be accessible to everyone. Where to obtain: The data can be received through the email registered here in the name of Maryam Dabbagh Shahir. M4ry4m.mdsh@gmail.com How to obtain: After receiving the email ,one or two weeks later, they will receive the data files. Comments:
public Maryam Dabbagh Shahir
Gavam 6 apartment, Emdad 1 Alley ,Modiriyat Ave.,Rahnamayi square., Rahnamayi Ave
Urmia Iran (Islamic Republic of) 5714781795 +98 44 3224 8760 M4ry4m.mdsh@gmail.com Oroumia University of Medical Sciences scientific Maryam Dabbagh Shahir
Gavam 6 apartment, Emdad 1 Alley ,Modiriyat Ave.,Rahnamayi square., Rahnamayi Ave
Urmia Iran (Islamic Republic of) 5714781795 +98 44 3224 8760 M4ry4m.mdsh@gmail.com Oroumia University of Medical Sciences Iran (Islamic Republic of) 6-12 year old children with moderate and severe allergic rhinitis 6 years 12 years Both Children with adenoide hyperplasia,bening and malignant tumors,pemphigus,nasal foreign body or nasal polyp Any trauma during the review period J00 Acute nasopharyngitis [common cold] Diagnosis Diagnosis Intervention group:Nasal cleansing test will be measured before and 4 weeks after nasal washing in all patients. 54 children will be taught to wash their nose regularly 3 times a day with normal saline solution for 6 weeks .Also , the patients will be treated with oral antihistamine drugs , and the amount of antihistamine drug consumption will be collected at the end of each week. Control group:Nasal cleansing test will be measured before and 4 weeks after nasal washing in all patients.54 patients will not wash their nose with normal saline.Also , the patients of will be treated with oral antihistamine drugs, and the amount of antihistamine drug consumption will be collected at the end of each week. Mucociliary Clearance Time. Timepoint: Before and 4 weeks after washing the nose with normal saline. Method of measurement: Minute. Quality of life of children with allergic rhinitis. Timepoint: Before and 4 weeks after washing the nose with normal saline. Method of measurement: According to the patients file. Urmia University of Medical Sciences Approved 2023-04-19 Ethics committee of Urmia University of Medical Sciences Gavam 6 apartment, Emdad 1 Alley ,Modiriyat Ave.,Rahnamayi square., Rahnamayi Ave Urmia West Azarbaijan Iran (Islamic Republic of)