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IRCT20201009048976N1 IRCT 2021-01-23 Shahid Beheshti University of Medical Sciences The effect of compound honey syrup on chronic sinusitis in cystic fibrosis patients The effect of compound honey syrup on clinical manifestations of chronic sinusitis in cystic fibrosis (CF) patients 2020-11-21 anticipated 40 Complete https://irct.ir/trial/51514 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Other, Randomization description: The randomization method is based on a table of random numbers and blocks of 4 and the study is double-blind, Blinding description: The compound honey syrup and placebo have been coded for blinding. The patient and researcher are unaware of the type of drug administered. 3 cystic fibrosis. Intervention 1: Intervention group: In addition to all the standard and required medicines for the patient, in the experimental group, compound honey syrup is also prescribed. Consumption of compound honey syrup, 5-10 cc (according to the weight of children, in the weight of over 30 kg, 10 cc and in the low weight of 30 kg, 5 cc) in 100 cc of boiled and lukewarm twice a day 30 minutes after the meal. The study period is 12 weeks. Intervention 2: Control group: In addition to all the standard and required drugs for the patient, in the control group, placebo approved by the pharmaceutical group (containing sodium saccharin) is also prescribed. Consumption of placebo syrup is 5-10 cc (according to the weight of children, in the weight of over 30 kg, 10 cc and in the low weight of 30 kg, 5 cc) in 100 cc of boiled and lukewarm water twice a day 30 minutes after the meal.The study period is 12 weeks. Yes - There is a plan to make this available What will be shared: Publishing results in the form of a Ph.D. thesis and an article indexing in ISI When: After PhD thesis defence To whom: Public Conditions: For research reasons Where to obtain: Shahid Beheshti University of Medical Sciences How to obtain: Approval of the relevant responsible Comments:
public samiraborhani
No8, Shams Alley, In front of Tavanir Ave., Vali-Asr Ave., Faculty of Traditional Medicine, Shahid Beheshti University of Medical Sciences
tehran Iran (Islamic Republic of) 1516745811 +98 21 8877 3521 samiraborhani@yahoo.com Shahid Beheshti University of Medical Sciences scientific Shahpar Kaveh Bagh Bahadorani
No8, Shams Alley, In front of Tavanir Ave., Vali-Asr Ave.
tehran Iran (Islamic Republic of) 1516745811 +98 21 8877 6029 samiraborhani@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients with cystic fibrosis with clinical signs of sinusitis over 6 years of age who refer to the pulmonary Clinic of Mofid Children's Hospital and enter the study with the informed consent of the parents of children and children over 6 years of age. 6 years no limit Both Patients with cystic fibrosis under 6 years of age referred to the pulmonary Clinic of the Mofid Children's Hospital, lack of clinical signs of sinusitis, patients in need of hospitalization and patients with increased cough, sputum and fever, and patients with underlying conditions such as allergic bronchopulmonary aspergillosis(ABPA) and Tuberculosis are not included in the study. E84 Cystic fibrosis Treatment - Drugs Placebo Intervention group: In addition to all the standard and required medicines for the patient, in the experimental group, compound honey syrup is also prescribed. Consumption of compound honey syrup, 5-10 cc (according to the weight of children, in the weight of over 30 kg, 10 cc and in the low weight of 30 kg, 5 cc) in 100 cc of boiled and lukewarm twice a day 30 minutes after the meal. The study period is 12 weeks. Control group: In addition to all the standard and required drugs for the patient, in the control group, placebo approved by the pharmaceutical group (containing sodium saccharin) is also prescribed. Consumption of placebo syrup is 5-10 cc (according to the weight of children, in the weight of over 30 kg, 10 cc and in the low weight of 30 kg, 5 cc) in 100 cc of boiled and lukewarm water twice a day 30 minutes after the meal.The study period is 12 weeks. Runny nose. Timepoint: At the beginning of the study(Before starting the intervention), the end of the Sixth and twelfth week. Method of measurement: SNOT questionnair. Nasal obstruction. Timepoint: At the beginning of the study, the end of the Sixth and twelfth week. Method of measurement: SNOT questionnair. Ear fullness. Timepoint: At the beginning of the study, the end of the Sixth and twelfth week. Method of measurement: SNOT questionnair. Dizziness. Timepoint: At the beginning of the study, the end of the Sixth and twelfth week. Method of measurement: SNOT questionnair. Ear pain. Timepoint: At the beginning of the study, the end of the Sixth and twelfth week. Method of measurement: SNOT questionnair. Facial pain/pressure. Timepoint: At the beginning of the study, the end of the Sixth and twelfth week. Method of measurement: SNOT questionnair. Shahid Beheshti University of Medical Sciences Approved 2020-04-19 Ethics Committee of Shahid Beheshti University of Medical Sciences Velenjak, Yaman Ave., Sh. Aarabi Ave., Shahid Beheshti University of Medical Sciences tehran Tehran Iran (Islamic Republic of)