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IRCT20200612047740N1 IRCT 2020-06-23 Esfahan University of Medical Sciences Effect of Combine Therapy by Mometasone Furoate and Azelastine with Single Therapy by Mometazone Furoate or Azelastine on Adenoid Size and Obstructive Symptoms in Patients Referring to ENT Clinic Effect and Comparison Between Combine Therapy by Mometasone Furoate and Azelastine with Single Therapy by Mometazone Furoate or Azelastine on Adenoid Size and Obstructive Symptoms in Patients Referring to ENT Clinic 2020-07-05 anticipated 60 Complete https://irct.ir/trial/48836 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are Randomly Assigned to the Groups of A, B and C Using Randomization Software, Blinding description: Nurse Participating in this Study, Give each Patient Code A, B and C According to Patients Number and classification. Doctor Checking Complications is not Aware of Using Drugs. Also Information Inserts to SPSS in the Form of Code and analyzer is Blind to the Classifications. All Drugs are Prepared and Placed at the Same Volume and Homogeneously by Investigator. 3 Obstruction Symptoms and Size of Adenoid. Intervention 1: Intervention group A: Initially, personal consent is obtained from the patients. Then nasal spray of Mometasone is used in each nostril, 1 puff, twice a day (50 micro gram in each puff) overally 200 micro gram a day for 30 days and obstructive symptoms is evaluated in the beginning and end of the treatment period. Intervention 2: Intervention group B: Initially, personal consent is obtained from the patients. Then nasal spray of Azelastine is used in each nostril, 1 puff, twice a day (125 micro gram in each puff) overally 500 micro gram a day for 30 days and obstructive symptoms is evaluated in the beginning and end of the treatment period. Intervention 3: Intervention group C : Initially, personal consent is obtained from the patients. Then nasal spray of Azelastine and Mometasone is used in each nostril, 1 puff, twice a day for 30 days and obstructive symptoms is evaluated in the beginning and end of the treatment period. Yes - There is a plan to make this available What will be shared: Only registered symptoms can be published without mentioning the names of the participants When: Starting the access period 6 months after printing results To whom: Only available to scholars working in academia and academia Conditions: Written request via email and university approval Where to obtain: By contacting the corresponding author How to obtain: After the email is received by the applicant, it takes one week to agree The university will be obtained and then will be notified to the requestor. Maximum of this process takes ten days. Comments:
public Jamileh Haghirzavare
Hezar Jerib
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 9801 jhaghirzavareh@gmail.com Esfahan University of Medical Sciences scientific Hossein Ghazavi
Hezar Jarib
Isfahan Iran (Islamic Republic of) 81745185 0098316683554 hossein.naderi1374@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) 6 to 12 Years old Children With Hypertrophy of Adenoid Grade 3 and 4 According to Cassano Grading 6 years 12 years Both Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group A: Initially, personal consent is obtained from the patients. Then nasal spray of Mometasone is used in each nostril, 1 puff, twice a day (50 micro gram in each puff) overally 200 micro gram a day for 30 days and obstructive symptoms is evaluated in the beginning and end of the treatment period Intervention group B: Initially, personal consent is obtained from the patients. Then nasal spray of Azelastine is used in each nostril, 1 puff, twice a day (125 micro gram in each puff) overally 500 micro gram a day for 30 days and obstructive symptoms is evaluated in the beginning and end of the treatment period Intervention group C : Initially, personal consent is obtained from the patients. Then nasal spray of Azelastine and Mometasone is used in each nostril, 1 puff, twice a day for 30 days and obstructive symptoms is evaluated in the beginning and end of the treatment period Obstructive Sleep Apnea. Timepoint: At the Beginning and End of 30 Days Treatment Duration. Method of measurement: Berlucchi Grading. Night Snoring. Timepoint: At the Beginning and End of 30 Days Treatment Duration. Method of measurement: Berlucchi Grading. Cough. Timepoint: At the Beginning and End of 30 Days Treatment Duration. Method of measurement: Berlucchi Grading. Rhinorrhea. Timepoint: At the Beginning and End of 30 Days Treatment Duration. Method of measurement: Berlucchi Grading. Nasal obstruction. Timepoint: At the Beginning and End of 30 Days Treatment Duration. Method of measurement: Berlucchi Grading. Adenoid size/nasopharyngeal depth ratio. Timepoint: At the Beginning and End of 30 Days Treatment Duration. Method of measurement: Lateral Nasopharynx Radiography. Esfahan University of Medical Sciences Approved 2020-03-13 Ethics committee of Isfahan University of Medical Sciences Hezar jarib Isfahan Isfehan Iran (Islamic Republic of)