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IRCT20230410057872N1 IRCT 2023-04-26 Ghoum University of Medical Sciences Investigating the effect of prednisolone in the bronchoscopic procedure in the treatment of patients with tracheal stenosis Investigating the effect of prednisolone in the bronchoscopic procedure in the treatment of patients with tracheal stenosis 2023-05-22 anticipated 40 Complete https://irct.ir/trial/69783 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, block randomization method will be used. First, we identify the patients who meet the conditions for entering the study. Then, using the randomization list that will be generated using R software, people will be randomly assigned to each of the treatment groups, Blinding description: In this study, the statistical sample is divided into two groups (n=20), so that in the control group, patients who undergo bronchoscopy, 3 weeks later (21 days) without receiving any medicine (receive placebo), undergo bronchoscopy again. And in the second group of patients, after the first stage bronchoscopy, they receive 0.5 mg/kg prednisolone daily for 3 weeks and after 21 days, they undergo bronchoscopy again. 0 (exploratory trials) Tracheal stenosis. Intervention 1: Intervention group: patients who receive 0.5 mg/kg of prednisolone daily for 3 weeks after first-stage bronchoscopy. Intervention 2: Control group: Patients who undergo bronchoscopy will undergo another bronchoscopy 3 weeks later (21 days) without receiving any medication (placebo). Yes - There is a plan to make this available What will be shared: All the data will be published in the article and thesis after removing the names of the patients When: 3 months after printing the results To whom: محققین شاغل در موسسات دانشگاهی و علمی Conditions: For scientific research Where to obtain: Hossein Falah dr_fallah69@yahoo.com How to obtain: Submit an academic application and a description of your study and the need for data for this study Comments:
public Hossein Falah
Qom University of Medical Sciences
Qom Iran (Islamic Republic of) 3713649373 +98 25 3107 1100 dr_fallah69@yahoo.com Ghoum University of Medical Sciences scientific Hossein Falah
Qom University of Medical Sciences
Qom Iran (Islamic Republic of) 3713649373 +98 25 3107 1100 dr_fallah69@yahoo.com Ghoum University of Medical Sciences Iran (Islamic Republic of) 1) Patients suffering from tracheal stenosis.2) Patients who have a stenosis equal to less than 1.5 cm.3) Patients who are candidates for rigid bronchoscopy 20 years 60 years Both 1) Patients who are candidates for bronchoscopy due to other diseases (except for tracheal stenosis).2) Patients whose stenosis length is more than 1.5 cm.3) Patients suffering from underlying diseases for whom corticosteroid administration is contraindicated. Treatment - Drugs Treatment - Drugs Intervention group: patients who receive 0.5 mg/kg of prednisolone daily for 3 weeks after first-stage bronchoscopy. Control group: Patients who undergo bronchoscopy will undergo another bronchoscopy 3 weeks later (21 days) without receiving any medication (placebo). Treatment of tracheal stenosis. Timepoint: 3 weeks later (21 days). Method of measurement: Bronchoscopy. Ghoum University of Medical Sciences Approved 2023-03-13 Ethics Committee of Qom University of Medical Sciences Qom University of Medical Sciences Qom Ghoum Iran (Islamic Republic of)