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IRCT20180718040520N1 IRCT 2020-03-24 Tehran University of Medical Sciences Effectiveness of Monteleukast in treatment of Adenoid Hypertrophy in Children Evaluating effects of montelukast added to nasal mometasone in comparison to placebo in the treatment of children with adenoid hypertrophy 2018-04-21 anticipated 120 Complete https://irct.ir/trial/33783 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: patients are divided into two groups bye clinic's file numbers. Odd numbers into group A and even numbers into group B, Blinding description: Person who dispenses the drug, data collector and data analyzer and the pateint is not aware of whether a drug or placebo is being given to each patient group. Drug and placebo are given to patients in 30 tablet packages labeled as A and B.Drug and placebo are identical in size, shape, and taste.patient and person delivering the drug are not aware of it being drug or placebo until the end of trial and analysis. Only after the end of the analysis it will be revealed whether group A or group B has received the drug. 3 Adenoid Hypertrophy. Intervention 1: Intervention group: monteleukast tab daily 5 mg for 2 months plus nasal mometason daily. Patients are followed in clinic or on phone in two sessions.drug is produced in Abidi Pharmaceuticals. Intervention 2: Control group: placebo with same packaging and shape for 2 months plus nasal mometason. Patients are followed in clinic or on phone in two sessions. Placebo is produced in Abidi Pharmaceuticals. Yes - There is a plan to make this available What will be shared: Data will be sent by request online. When: March 2020 to june2020 To whom: Examiners Conditions: By examiners request Where to obtain: Main researcher , Bahar Pourroshani, contact by email address bahar.pourroshani@gmail.com How to obtain: After researcher recieives the email , she will respond the request by email. Comments:
public Bahar Pourroshani
Bahrami children hospital, Ansar-ol-hossein st., Sabalan st
Tehran Iran (Islamic Republic of) 1641744991 +98 21 8819 2716 bahar.pourroshani@gmail.com Tehran University of Medical Sciences scientific Bahar Pourroshani
Bahrami children hospital, Ansar-ol-hossein st., Sabalan st
Tehran Iran (Islamic Republic of) 1641744991 +98 21 8819 2716 bahar.pourroshani@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) hypertrophy of adenoids confirmed clinically and radiologically Current use of nasal Mometason No contraindication for corticosteroids or monteleukast No previous adenoidectomy Patients and parents consent age 2 to 14 years 2 years 14 years Both Allergic to nasal corticosteroids or antileukotriens Craniofacial, neuromuscular disorders or syndromes Acute upper respiratory tract infection Use of corticosteroids or antibiotics within last 2 weeks drug reactions requiring medication change patients who require surgical treatment while participating patient or parent refusal J35.2 Hypertrophy of adenoids Treatment - Drugs Placebo Intervention group: monteleukast tab daily 5 mg for 2 months plus nasal mometason daily. Patients are followed in clinic or on phone in two sessions.drug is produced in Abidi Pharmaceuticals. Control group: placebo with same packaging and shape for 2 months plus nasal mometason. Patients are followed in clinic or on phone in two sessions. Placebo is produced in Abidi Pharmaceuticals. Mouth breathing. Timepoint: before intervention and 1 months after and 2 months after intervention. Method of measurement: questionnaire. Nasal Voice. Timepoint: before intervention and 1 months after and 2 months after intervention. Method of measurement: questionnaire. Snoring. Timepoint: before intervention and 1 months after and 2 months after intervention. Method of measurement: questionnaire. Tehran University of Medical Sciences Approved 2018-06-30 Institutional Research Ethics Committee of Tehran School of Medicine 13th Floor, Block A, Tehran Tehran Iran (Islamic Republic of)