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IRCT20200103045989N1 IRCT 2021-12-21 Shahid Beheshti University of Medical Sciences The Efficacy of Compound Honey Syrup in Cystic Fibrosis Patients The efficacy of Compound Honey Syrup on Fractional Exhalation Nitric Oxide (FeNO) Changes, Pulmonary Symptoms and Body Mass Index (BMI) in Cystic Fibrosis Patients 2021-11-06 anticipated 40 Complete https://irct.ir/trial/44752 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive. 2 Cystic Fibrosis. Intervention 1: Intervention group: Includes patients with cystic fibrosis over 6 years of age referred to the pulmonary clinic of Mofid Children's Hospital who are able to perform FeNO test.Lung examination for pulmonary symptoms and FeNO test performed by standing pulmonary fellowship, patient's BMI is measured.In the next stage, all standard and required treatments of the patient are prescribed, and in addition to routine treatments, compound honey syrup is also prescribed.Consumption of compound honey syrup is 5-10 cc (depending on the weight of children, 10 cc over 30 kg and 5 cc under 30 kg) in 100 cc of boiled water twice a day 30 minutes after a meal.Compound honey syrup is produced by NIAK Pharmaceutical Company with the permission of the Food and Drug Administration of the Ministry of Health and Medical Education. This syrup contains compounds of honey, cinnamon, ginger, saffron and cardamom .The patient was followed up by the researcher in the second and fourth weeks after the first visit and in the sixth week, the patient referred again to the pulmonary clinic of Mofid Children's Hospital for examination by a pulmonologist and then in the eighth and tenth weeks followed by the researcher by phone, and finally in the twelfth week for the final visit to be examined by a pulmonologist, FeNO test and CFQ-R questionnaire in terms of Pulmonary symptoms are also complemented. Intervention 2: Control group: Includes patients with cystic fibrosis over 6 years of age referred to the Pulmonary Clinic of Mofid Children's Hospital who are able to perform FeNO testing. The patient is examined by the pulmonary fellowship for pulmonary symptoms and BMI, and each patient's information is entered into a CFQ-R questionnaire. In other words, information is collected for each patient before starting treatment with honey syrup. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Nafise Fadavi
No. 5, Yas building, Mobarezan Ave, Bozorgmehr street
Ardestan Iran (Islamic Republic of) 8156676155 +98 31 3230 2382 nf.fadavi@yahoo.com Shahid Beheshti University of Medical Sciences scientific Nafise Fadavi
No. 5, Yas building, Mobarezan Ave, Bozorgmehr street
Ardestan Iran (Islamic Republic of) 8156676155 +98 31 3230 2382 nf.fadavi@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) All patients with cystic fibrosis over 6 years who are able to perform FeNO test. 6 years no limit Both Patients with cystic fibrosis under 6 years Patients in need of hospitalization Patients who have exacerbation (increased cough, sputum, fever and need to be hospitalized) Patients with underlying diseases such as allergic bronchopulmonary aspergillosis, heart failure, tuberculosis Patients with another acute illness during treatment Patients who are allergic to any component of the compound honey syrup Patients requesting exclusion Patients unable to perform FeNO test. ICD-10 Treatment - Drugs Treatment - Drugs Intervention group: Includes patients with cystic fibrosis over 6 years of age referred to the pulmonary clinic of Mofid Children's Hospital who are able to perform FeNO test.Lung examination for pulmonary symptoms and FeNO test performed by standing pulmonary fellowship, patient's BMI is measured.In the next stage, all standard and required treatments of the patient are prescribed, and in addition to routine treatments, compound honey syrup is also prescribed.Consumption of compound honey syrup is 5-10 cc (depending on the weight of children, 10 cc over 30 kg and 5 cc under 30 kg) in 100 cc of boiled water twice a day 30 minutes after a meal.Compound honey syrup is produced by NIAK Pharmaceutical Company with the permission of the Food and Drug Administration of the Ministry of Health and Medical Education. This syrup contains compounds of honey, cinnamon, ginger, saffron and cardamom .The patient was followed up by the researcher in the second and fourth weeks after the first visit and in the sixth week, the patient referred again to the pulmonary clinic of Mofid Children's Hospital for examination by a pulmonologist and then in the eighth and tenth weeks followed by the researcher by phone, and finally in the twelfth week for the final visit to be examined by a pulmonologist, FeNO test and CFQ-R questionnaire in terms of Pulmonary symptoms are also complemented. Control group: Includes patients with cystic fibrosis over 6 years of age referred to the Pulmonary Clinic of Mofid Children's Hospital who are able to perform FeNO testing. The patient is examined by the pulmonary fellowship for pulmonary symptoms and BMI, and each patient's information is entered into a CFQ-R questionnaire. In other words, information is collected for each patient before starting treatment with honey syrup. FeNO. Timepoint: At the beginning of the study and 12 weeks after the administration of the compound honey syrup. Method of measurement: FeNO Testing Device. Body Mass Index. Timepoint: At the beginning of the study and 12 weeks after the administration of the compound honey syrup. Method of measurement: Weight / Squared Height. Pulmonary Symptoms. Timepoint: At the beginning of the study and 12 weeks after the administration of the compound honey syrup. Method of measurement: CFQ-R questionnaire. Shahid Beheshti University of Medical Sciences Approved 2020-01-18 کمیته ملی اخلاق در پژوهش های زیست پزشکی Evin, Shahid Shahriari Square Tehran Tehran Iran (Islamic Republic of)