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Study aim
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The effect of compound honey syrup on clinical manifestations of chronic sinusitis in cystic fibrosis (CF) patients
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Design
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This study is a double-blind randomized clinical trial with a sample size of 40 cases.
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Settings and conduct
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This double-blind study is performed in the lung clinic of Mofid Children's Hospital in Tehran. At the first visit, the relevant questionnaires are completed and the examination is performed by the pulmonary specialist. All standard medications are prescribed. The patient is followed up by phone in the second, fourth, eighth and tenth weeks and in the sixth week, re-examination, control of drug side effects, filling out the questionnaire, re-administration of the drugs are performed. Finally, in the twelfth week, the final visit will be made and the questionnaires will be completed.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
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 if they receive informed consent from the parents of children and children over 6 years old
Criteria for not entering:
Patients with cystic fibrosis under 6 years of age, lack of clinical signs of sinusitis, patients in need of hospitalization and patients with underlying conditions such as allergic bronchopulmonary aspergillosis (ABPA) and Tuberculosis
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Intervention groups
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All standard and required drugs are prescribed to the patient and in the experimental group, in addition to the above treatments, combined honey syrup and in the control group, the placebo is also prescribed. Consumption of compound honey syrup and placebo, 5-10 cc (according to the weight of children) in 100 cc of boiled and lukewarm water twice a day 30 minutes after meal.
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Main outcome variables
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Runny nose ,Nasal obstruction ,Ear fullness ,Dizziness ,Ear pain ,Facial pain/pressure