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IRCT20200727048222N1 IRCT 2020-09-26 Sabzevar University of Medical Sciences Comparison of the effect of Olapatadine nasal spray with Mometasone spray in the treatment of allergic rhinosinusitis Evaluation of the effect of Olopatadine nasal spray compared to Mometasone spray in the treatment of allergic rhinosinusitis cases refered to ENT clinic of Heshmatieh Hospital Sabzevar 2020-08-21 anticipated 100 Complete https://irct.ir/trial/50204 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomization, a simple block method will be used. The individual randomization unit and the randomization tool are sealed drug packages that are completely similar in shape and the patient and the project operator are not aware of the contents of the packages. The allocation of samples in the study will be based on a random sequence provided by the statistical consultant using statistical software. The sequence used will be quadruple blocks. Random allocation software is also a tool for generating random block sequences, Blinding description: In order to blind each patient, it is numbered by the supervisor and recorded in a notebook; For example, patient No. 1 receives box A medicine and patient number 2 receives box B medicine. While the researcher and patients do not know the content of the drug in the envelopes. 3 Allergic rhinosinusitis. Intervention 1: Intervention group: Olopatadine nasal spray 0.6% every 12 hours (made by Daroo Pakhsh Tehran). Intervention 2: Intervention group: Mometasone 50 mg nasal spray every 6 hours (made by Caspian Drug Company of Rasht). 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 no more information.
public Ehsan Ebrahimzadeh
Memarzadeh St., 5th Enghelab Street,Najarabad Boulevard., Sabzevar Town
Sabzevar Iran (Islamic Republic of) 9617213112 +98 51 4424 3658 ehsanebrahimzadeh@yahoo.com Sabzevar University of Medical Sciences scientific Ehsan Ebrahimzadeh
Memarzadeh St., 5th Enghelab Street,Najarabad Boulevard., Sabzevar Town
Sabzevar Iran (Islamic Republic of) 9617213112 +98 51 4424 3658 ehsanebrahimzadeh@yahoo.com Sabzevar University of Medical Sciences Iran (Islamic Republic of) Age 18 to 60 years Patients with confirmed allergic rhinosinusitis Written consent to enter the study Patient cooperation during the study Timely and correct use of medication by asking the patient Absence of abnormal nasal anatomy Absence of severe nasal congestion due to polyps, other lesions and obstructive masses Absence of respiratory infections Non-smokers Absence of upper and lower lung diseases affecting the final consumption or absorption of the nose Absence of symptoms of systemic diseases 18 years 60 years Both People known for not responding to antihistamines Known intolerance or sensitivity to drugs J99 Allergic rhinosinusitis Treatment - Drugs Treatment - Drugs Intervention group: Olopatadine nasal spray 0.6% every 12 hours (made by Daroo Pakhsh Tehran) Intervention group: Mometasone 50 mg nasal spray every 6 hours (made by Caspian Drug Company of Rasht) Response to treatment of olapatadine and mometasone spray groups. Timepoint: Before the intervention and on days 1, 3 and week 2 after starting the medication. Method of measurement: Sino Nasal Outcome Test 22 questionnaire. Satisfaction of patients receiving olapatadine and mometasone spray groups. Timepoint: 2 weeks After starting the intervention. Method of measurement: 5 point scale. Sabzevar University of Medical Sciences Approved 2020-06-20 Ethics Committee of Sabzevar University of Medical Sciences Memarzadeh Alley, Enghelab St 5., Najar Abad Blvd Sabzevar Razavi Khorasan Iran (Islamic Republic of)