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IRCT20250217064754N1 IRCT 2025-07-08 Mashhad University of Medical Sciences The effect of saline Plus on cystic fibrosis patients Investigating the effectiveness of 7% plus hypertonic saline compared to 7%hypertonic saline in reducing the growth of Pseudomonas in the lungs of cystic fibrosis patients 2025-06-05 anticipated 64 Complete https://irct.ir/trial/82028 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, the block method will be used to generate the sequence of random allocation of individuals to the study groups. The sequence of random allocation of individuals will be done using Random Allocation Software and a block size of 4, Blinding description: 1. Blinding of participants - Both types of saline (7% regular and 7% plus) are provided in identical containers (same brand, color, shape, and packaging). - Labels are marked only with random codes (e.g., A or B) and do not indicate the type of drug. - If the drugs have a different taste or smell, a neutral flavoring or color is used so that they are not distinguishable. 2. Blinding of investigators (drug prescribing team) - The research team does not have access to the randomization list (this list is managed by a pharmacist or a central system outside the team). - The drugs are pre-coded, and the investigator only gives the code (e.g., vial “A”) to the patient without knowing the contents. - In the event of adverse events, reports are recorded without specifying the treatment group. 3. Blinding of outcome assessors (data analysis team) - Samples (e.g., sputum cultures) are sent to the laboratory with numerical codes (not A/B). - Assessors do not know which treatment group each sample belongs to. 3 cystic fibrosis. Intervention 1: Intervention group: Patients in the intervention group received 4 cc of 7% hypertonic saline plus nebulizer, manufactured by Samen Pharmaceutical Company, every 12 hours for three months. Intervention 2: Control Group: Patients in the control group receive 4 cc of 7% hypertonic saline nebulizer, manufactured by Samen Pharmaceutical Company, every 12 hours for three months. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Faezeh Samadi
Opposite Shahid Kaveh 14, Shahid Kaveh Blvd., Mashhad, Khorasan Razavi, Iran
Mashhad Iran (Islamic Republic of) 9177897157 +98 51 3866 5512 fasamadi100@gmail.com Mashhad University of Medical Sciences scientific Faezeh Samadi
Akbar Hospital, Shahid Kaveh Blvd.,
Mashhad Iran (Islamic Republic of) 9919191778 +98 51 3866 5512 fasamadi100@gmail.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Have cystic fibrosis ability to expectorate sputum The patient is in stable condition Pseudomonas sputum culture The forced expiratory volume in the first second is greater than 50%. 6 years 14 years Both Hyperreactive pulmonary disease Oxygen saturation less than 94% in room air or with supplemental oxygen Use of intravenous antibiotics during the previous four weeks Change in cystic fibrosis medications in the past four weeks E84 Cystic fibrosis Prevention Placebo Intervention group: Patients in the intervention group received 4 cc of 7% hypertonic saline plus nebulizer, manufactured by Samen Pharmaceutical Company, every 12 hours for three months. Control Group: Patients in the control group receive 4 cc of 7% hypertonic saline nebulizer, manufactured by Samen Pharmaceutical Company, every 12 hours for three months. Colony growth rate of Pseudomonas aeruginosa in sputum of patients. Timepoint: Before the intervention begins and after the intervention ends. Method of measurement: Pseudomonas colony count by throat culture. The Forced Expiratory Volume in 1 second. Timepoint: Before the intervention begins and after the intervention ends. Method of measurement: Spirometry. The total forced vital capacity. Timepoint: Before the intervention begins and after the intervention ends. Method of measurement: Spirometry. Body mass index. Timepoint: Before the intervention begins and after the intervention ends. Method of measurement: Meters and scales. Mashhad University of Medical Sciences Approved 2024-11-26 Ethics Committee of the Faculty of Medicine, Mashhad University of Medical Sciences Central Organization of Mashhad University of Medical Sciences, Knowledge and Health Town,between Shahid Al-Shahidi Square and Shahid Javan Square, , end of Shahid Fakuri Boulevard, , Mashhad city, Khorasan Razavi Mashhad Razavi Khorasan Iran (Islamic Republic of)