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IRCT20090808002306N7 IRCT 2021-07-17 Esfahan University of Medical Sciences Oral N-acetylcysteine (NAC) effectiveness in cystic fibrosis (CF) The effectiveness of oral N-acetylcysteine (NAC) comparing to placebo on quality of life and respiratory profile of patients aged 6 to 18 years old with cystic fibrosis having mild to moderate pulmonary involvement 2021-04-03 anticipated 45 Complete https://irct.ir/trial/57222 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Before entering the study, how to conduct a clinical trial for children / adolescents and their parents will be fully explained and the consent form will be provided to patients both children / adolescents and parents or legal guardians. Individuals in the above method will be randomly divided into two groups of case and control, both groups will receive standard treatment and the intervention group in addition to standard treatment, N acetylcysteine (NAC) ​​oral tablet and the control group will also receive placebo. In order to ensure the correct use of the drug, in addition to the initial training, the pill count method will be used during the follow-up of patients, and if patients have more than 40% difference with the expected number of remaining pills, they will be excluded.from the study. Two hundred mg NAC tablets produced by the pharmaceutical company Mucosulin and placebo with a brand similar in appearance to the main drug are produced by the Isfahan School of Pharmacy and given to the control group. Before receiving the drug, patients in both groups, Spirometry is tested and the indicators mentioned in the targets are recorded. Also, at the beginning of the study, patients' demographic information and details related to the severity of cystic fibrosis (CF) symptoms are recorded in a data collection form. In both case and control groups, receive standard treatment (including saline nebulizers, digestive enzymes, etc.) and to evaluate the effectiveness of N-acetylcysteine ​​in patients with CF in the case group, 600 mg of this drug daily (every eight hours 200 mg tablets) for one to three months. The control group also takes placebo tablets. Then spirometry test is performed on the patients again and the results are compared before and after the intervention in the considered indicators. Spirometry testing is based on the ATS guideline. Before the start of the study, the quality of life of these patients was assessed using the Cystic Fibrosis Questionnaire-Revised (CFQR) and compared between the case and control groups, based on before and after the intervention. Accuracy and reliability of case tests The opinion has been proven in several studies, and during the monitoring of patients during treatment, the possibility of side effects will be reported as observed.۴۵, Randomization description: In this study, randomization using the date of birth of patients referred to the outpatient cystic fibrosis treatment clinic of Imam Hossein Pediatric Hospital on Thursdays (Simple Random Sampling) is performed. In this method, using patients' birthdays, all eligible admitted individuals will be divided into two groups of 15 people, case and control. (Birthday of the individual in the case group and birthday of the couple in the control group.) Then the numbers, respectively. Depending on the number or even number of each patient, a treatment regimen with or without NAC is considered, Blinding description: In this study, the pulmonologist and patients are not aware of the type of drug prescribed (main drug or placebo). Drugs with only a small code that only the researcher and data collector (student) is aware of that code. 2-3 Cystic fibrosis. Intervention 1: Intervention group: N acetylcysteine ​​at a dose of 200 mg 3 times a day for 3 months by a pharmaceutical company. Intervention 2: Control group: receiving standard treatment for cystic fibrosis plus placebo with the same shape every 8 hours for 3 months. 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 Mir Ali Mohammed Sabzeghabaiei
Hezar jarib
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 7070 sabzghaba@pharm.mui.ac.ir Esfahan University of Medical Sciences scientific Mir Ali Mohammed Sabzeghabaiei
Hezar jarib street
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 7070 sabzghaba@pharm.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) 1. The amount of chlorine in the sweat test is greater than or equal to 60 milliequivalents per liter or the presence of genotype containing two diagnostic mutations associated with CF and accompanied by one or more stable clinical symptoms specific to the specific phenotype of cystic fibrosis patients. 2. patients aged range of 6 to 18 years 3. The level of FEV1 or Forced Expiratory Volume is more than 50% 4. Stable clinical condition in the patient and no acute infection in the patient's upper and lower respiratory system 5. Do not aggravate the patient's pulmonary symptoms for 14 days before the patient's clinical examination 6 years 18 years Both Disability to perform and repeat spirometry test according to American Thoracic Society criteria use of other drugs out of the common treatment protocol that is effective on the disease. Having possible history of underlying cardiovascular, renal, hepatic and biliary tract diseases E88.8 Other specified metabolic disorders Treatment - Drugs Placebo Intervention group: N acetylcysteine ​​at a dose of 200 mg 3 times a day for 3 months by a pharmaceutical company. Control group: receiving standard treatment for cystic fibrosis plus placebo with the same shape every 8 hours for 3 months Quality of life in children with cystic fibrosis;. Timepoint: At the beginning of the study and 3 months later,. Method of measurement: Cystic fibrosis Questionnaire -Revised (CFQR). FEV1/FVC, proportion of a person's vital capacity that they are able to expire in the first second of forced expiration to the full, forced vital capacity. Timepoint: At the beginning of the study and 3 months later. Method of measurement: By spirometry. FEV1, Forced Expiratory Volume in First Second. Timepoint: At the beginning of the study and 3 months later. Method of measurement: By spirometry. FEF25-75, Exhale middle airflow. Timepoint: At the beginning of the study and 3 months later. Method of measurement: Spirometry. Quality of life in cystic fibrosis patients. Timepoint: At the first beginning of the study and 3 months later. Method of measurement: By a questionnaire Cystic Fibrosis Questionnaire -Revised (CFQR). Esfahan University of Medical Sciences Approved 2021-05-08 Ethics committee of Isfehan University of Medical Sciences Hezar jarib street Isfehan Isfehan Iran (Islamic Republic of)