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IRCT20200906048642N1 IRCT 2020-09-16 Shiraz University of Medical Sciences Comparison of montelukast and intranasal antihistamine in allergic rhinitis treatment Comparative study of montelukast and intranasal antihistamine in treatment of moderate to severe allergic rhinitis in Shiraz Emam Reza Clinic in 2020 2020-04-20 anticipated 66 Complete https://irct.ir/trial/50794 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: According to clinic reception number, the patients divided respectively to two intervention and one control group. 3 Allergic rhinitis. Intervention 1: Intervention group: Treatment group with Montelukast and Budesonide nasal spray in this group consisting of 22 patients.Montelukast Dr.Abidi factory with a dose of 5 mg per day to patients aged 6 to 14 years and 10 mg per day to patients older than 14 years and budesonide nasal spray twice a day, one puff is prescribed for patients over 6years and once a day, one intranasal puff to patients aged6-14 years. Treatment lasts for three months. The patient's symptoms are checked monthly. Intervention 2: Intervention group: Azelastine nasal spray and budesonide nasal spray. Treatment group with azalastine nasal spray and budesonide nasal spray with 22patients receiving intranasal antihistamine (Azelastine) with a dose of one puff twice a day for patients between 6 to 12 years and two puffs twice a day for patients older than 12 years and budsonide nasal spray is prescribed. Azalastine (Zelex ) spray produced by World Health Pharmaceutical Company, which was prescribed for three months of treatment. Intervention 3: Control group: nasal spray budesonide (Naxonella spray 64 micrograms / dose 120 puffs) which is administered two puff intranasal twice daily for older than 12years and for6-12 years twice daily one puff intranasally. Standard treatment for moderate to severe allergic rhinitis is nasal corticosteroid spray which in this study is budesonide and the same dose is used in all groups. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is not more information
public Nasrin Mortazavi Far
Pediatric department-Namazi Hospital _Namazi Square-Shiraz
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3647 4334 nasrinmortazavi@yahoo.com Shiraz University of Medical Sciences scientific Nasrin Mortazavi Far
Pediatric department-Namazi Hospital _Namazi Square-Shiraz
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3647 4334 nasrinmortazavi@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Moderate to severe allergic rhinitis Seasonal and perennial allergic rhinitis 6 years 50 years Both Mild or intermittent allergic rhinitis Chronic diseases under treatment(chronic kidney disease,hypertension,diabetes mellitus) History of drug reaction Immunotherapy Infectious rhinosinusitis J30.9 Allergic rhinitis, unspecified Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Treatment group with Montelukast and Budesonide nasal spray in this group consisting of 22 patients.Montelukast Dr.Abidi factory with a dose of 5 mg per day to patients aged 6 to 14 years and 10 mg per day to patients older than 14 years and budesonide nasal spray twice a day, one puff is prescribed for patients over 6years and once a day, one intranasal puff to patients aged6-14 years. Treatment lasts for three months. The patient's symptoms are checked monthly. Intervention group: Azelastine nasal spray and budesonide nasal spray. Treatment group with azalastine nasal spray and budesonide nasal spray with 22patients receiving intranasal antihistamine (Azelastine) with a dose of one puff twice a day for patients between 6 to 12 years and two puffs twice a day for patients older than 12 years and budsonide nasal spray is prescribed. Azalastine (Zelex ) spray produced by World Health Pharmaceutical Company, which was prescribed for three months of treatment. Control group: nasal spray budesonide (Naxonella spray 64 micrograms / dose 120 puffs) which is administered two puff intranasal twice daily for older than 12years and for6-12 years twice daily one puff intranasally. Standard treatment for moderate to severe allergic rhinitis is nasal corticosteroid spray which in this study is budesonide and the same dose is used in all groups. Quality of life via SNOT22. Timepoint: Monthly up to 3 months. Method of measurement: SNOT22 questionnaire. Patient symptoms. Timepoint: Monthly to 3 months. Method of measurement: SNOT22 questionnaire. Shiraz University of Medical Sciences Approved 2020-07-20 Ethics committee of Shiraz University of Medical Sciences Shiraz university of Medical Science, Zand street, Shiraz Shiraz Fars Iran (Islamic Republic of)