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IRCT20251021067707N1 IRCT 2025-10-25 Oroumia University of Medical Sciences Evaluating the Efficacy of oral Montelukast in 5-14 year old children hospitalized with severe exacerbated asthma Evaluating the Efficacy of oral Montelukast in 5-14 year old children hospitalized with severe exacerbated asthma 2025-11-22 anticipated 72 Complete https://irct.ir/trial/86953 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly assigned to two intervention groups using Excel software (36 patients, routine treatment regimen for moderate to severe asthma plus montelukast 5 mg orally/daily) and control (36 patients, routine treatment regimen for moderate to severe asthma plus oral placebo/daily), Blinding description: Study participants will be blinded to the placebo, and the outcome assessor will be blinded to the group they are in. 4 Severe Exacerbation of Asthma. Intervention 1: Intervention group: Routine treatment regimen for moderate to severe asthma plus montelukast 5 mg orally/day. Intervention 2: Control group: Control group: Routine moderate to severe asthma treatment regimen plus oral/daily placebo. 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 So far, we haven't had enough reason to release people's information.
public Saeed Choupani
No. 2, Kani 5, Kholafayeh Rashedin Boulevard, Andisheh Town
Boukan Iran (Islamic Republic of) 5716114819 +98 44 4625 4148 schoopany1373@gmail.com Oroumia University of Medical Sciences scientific Saeed Choupani
No. 2, Kani 5, Kholafayeh Rashedin Boulevard, Andisheh Town
Boukan Iran (Islamic Republic of) 5716114819 +98 44 4625 4148 schoopany1373@gmail.com Oroumia University of Medical Sciences Iran (Islamic Republic of) Age 5 to 14 years old Hospitalized with a diagnosis of severe asthma attack Patients who have used salbutamol in the past two weeks A diagnosed history of moderate to severe persistent asthma Not taking Montelukast 5 years 14 years Both Parents' lack of consent to participate in the study Patients who are taking phenytoin, phenobarbital, or rifampicin (due to drug interactions) The presence of any other possible diagnoses that mimic asthma symptoms There are clear contraindications for prescribing montelukast. The occurrence of dangerous side effects and drug allergies to montelukast J45.51 Severe Exacerbation of Asthma Treatment - Drugs Placebo Intervention group: Routine treatment regimen for moderate to severe asthma plus montelukast 5 mg orally/day Control group: Control group: Routine moderate to severe asthma treatment regimen plus oral/daily placebo Length of hospital stay. Timepoint: The entire length of hospital stay. Method of measurement: Hospital file. The need for adjunctive therapies such as magnesium sulfate. Timepoint: The entire length of hospital stay. Method of measurement: Hospital file. The occurrence of drug side effects including headache, nausea, diarrhea, and hives. Timepoint: The entire duration of hospitalization. Method of measurement: Taking a patient history. Differences in response to treatment based on the type of triggering agent (infectious or non-infectious). Timepoint: The entire duration of hospitalization. Method of measurement: Taking a patient history. Oroumia University of Medical Sciences Approved 2025-09-24 Research Ethics Committees of Urmia University of Medical Sciences Resalat Boulevard Urmia West Azarbaijan Iran (Islamic Republic of)