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IRCT20150426021944N5 IRCT 2024-05-31 Oroumia University of Medical Sciences Comparing the efficacy of a combination of Mometasone and Olopatadine sprays versus Mometasone spray in children with allergic rhinitis Comparing the efficacy of a combination of Mometasone and Olopatadine sprays versus Mometasone spray in children with allergic rhinitis 2024-06-19 anticipated 80 Complete https://irct.ir/trial/76855 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The block randomization method will be utilized to assign participants to two groups. The block size will be set at 8, initially listing all possible combinations of AAAABBBBB with a unique code for each. Subsequently, 10 blocks will be randomly selected based on a sample size of n=80, and participants will be allocated according to the order of these chosen blocks. The complete randomization procedure will be conducted using random allocation software overseen by an epidemiology expert, Blinding description: Blinding will be three-way. The drugs (spray) will be prepared and given to the patients in uniform and identical containers without labels. The list of patients will be listed based on secret codes, which will be available to the researcher, evaluator, and statistical analyzer. Only one nurse outside of the research team will have access to the list to take action on complications. 3 Allergic rhinitis. Intervention 1: Intervention group: Patients receiving two sprays of mometasone and allanthin with doses of 25 micrograms and 665 micrograms twice a day (every 12 hours). Intervention 2: Control group: Patients receiving mometasone spray alone at a dose of 25 mcg every 12 hours. No - There is not a plan to make this available Justification or reason for not sharing IPD is According to the ethical considerations and policies of the institution (University of Medical Sciences), there will be no sharing of data and it is subject to obtaining the necessary permits.
public Hamidreza Hoshmand
Motaharihospital, kashani St, Urmia, I.R. IRAN
urmia Iran (Islamic Republic of) 5715917611 +98 44 3223 7080 motahari-h-urm@umsu.ac.ir Oroumia University of Medical Sciences scientific ِِDr. Hamid Reza Houshmand
Kashani street
Orumia Iran (Islamic Republic of) 57159-74677 0098 44 3334592 hamidreza.houshmand@gmail.com Oroumia University of Medical Sciences Iran (Islamic Republic of) Allergic rhinitis diagnosis by a clinical allergist collaborating in the project (based on the presence of clinical symptoms such as sneezing, nasal congestion, nasal secretions, and nasal itching or based on a positive prick test or a positive IgE specific to allergens) Age 6-12 years old Obtaining written informed consent from parents 6 years 12 years Both Known history of nasal polyps, other clinically significant respiratory system abnormalities Structural abnormalities of the nose Septum deviation Chronic, acute, or significant sinusitis or post-nasal drip (PND) Drug-induced rhinitis; active pulmonary disorder or infection (e.g., bronchitis, pneumonia, or influenza) Upper respiratory tract or sinus infection within the past 14 days Other important clinical abnormalities of the respiratory system J30 Vasomotor and allergic rhinitis Treatment - Drugs Treatment - Drugs Intervention group: Patients receiving two sprays of mometasone and allanthin with doses of 25 micrograms and 665 micrograms twice a day (every 12 hours) Control group: Patients receiving mometasone spray alone at a dose of 25 mcg every 12 hours Quality of life. Timepoint: Days 7, 1 and 14 after intervention. Method of measurement: Pediatric Rhino Conjunctivitis Quality of Life Questionaire( PRQLQ). TNSS questionnaire. Timepoint: Days 7, 1 and 14 after the intervention. Method of measurement: TNSS questionnaire(Total Nasal Symptom Score: TNSS). Urmia University of Medical Sciences Approved 2023-11-19 Ethics committee of Urmia University of Medical Science Urmia University of Medical Sciences, Orzhans Alley, Resalat St. ,Urmia , Iran Urmia West Azarbaijan Iran (Islamic Republic of)