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IRCT20250524065876N1 IRCT 2025-08-23 Bagheiat-allah University of Medical Sciences Effect of 7% Hypertonic Saline Nebulization on Lung Function and Quality of Life in Chemical Warfare Veterans Evaluation of the Impact of 7% Sodium Chloride Nebulization on Lung Function and Quality of Life in Chemical War Veterans 2025-09-02 anticipated 62 Complete https://irct.ir/trial/84559 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, block randomization with a block size of 4 will be used to allocate participants into two groups: the intervention group (receiving 7% NaCl via mesh nebulizer) and the control group (receiving normal saline). Randomization will be performed at the individual level, with stratification based on the severity of pulmonary disease (moderate/severe). The random sequence will be generated using R software and placed in sealed envelopes to ensure proper allocation concealment. An independent colleague will be responsible for managing the envelopes, and both patients and researchers will remain blinded to group assignments until the intervention begins (double-blind). This method prevents imbalance between groups and has been designed in accordance with CONSORT standards for randomized clinical trials, Blinding description: In this study, a strict double-blinding system is designed in which both patients and investigators will be unaware of the type of treatment they will receive. Patients will be treated without knowing the actual content of the nebulized solutions (7% NaCl or normal saline), while the treating physicians, nurses, outcome assessors, and data collection team will also be unaware of the group allocation of patients. Drug solutions will be prepared and delivered by the project pharmacist in completely identical containers without special markings. Statistical analysts will also not be aware of the grouping codes until the end of the primary analysis phase. Only the safety and data monitoring committee will have access to the actual data to monitor the safety of the study. 2-3 Chemical pneumonitis induced by sulfur mustard gas. Intervention 1: Intervention group: Patients in the intervention group receive 7% sodium chloride solution (hypertonic saline) through an Omron NE-U22 mesh nebulizer device. The treatment protocol includes administering 4 ml of the solution twice a day (every 12 hours) for 8 weeks. Each nebulization session lasts about 10-15 minutes and patients are required to observe a 30-minute interval before and after meals and rinse their mouth after each use. The sterile solution used is provided by saha Pharmaceutical Company and all patients receive complete practical training on the correct use of the device before starting the intervention. Intervention 2: Control group: Patients in this group receive 0.9% normal saline solution (placebo) with the same Omron NE-U22 mesh nebulizer device, with a completely similar protocol to the intervention group (4 ml, twice a day for 8 weeks). The placebo solution is prepared by the same manufacturer (saha) and is presented in containers that are completely similar in shape and packaging. All instructions for use, patient education, weekly follow-ups, and drug prohibitions in this group are also followed exactly the same as in the intervention group so that the specific effects of hypertonic saline can be properly assessed. 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 No more information available.
public Mansoureh Molaei
Corner of Sheikh Bahai St. & Molla Sadra St. Vanak Square, Tehran, Iran
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8804 0060 mollaeimansoure5@gmail.com Bagheiat-allah University of Medical Sciences scientific Mansoureh Molaei
Corner of Sheikh Bahai St. & Molla Sadra St. Vanak Square, Tehran, Iran
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8804 0060 mollaeimansoure5@gmail.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Chemical warfare veteran with documented exposure to sulfur mustard gas Medically confirmed pulmonary complications due to sulfur mustard exposure Moderate to severe degree of pulmonary involvement Age between 40-70 years No acute respiratory infection in the past 4 weeks No changes in baseline medications in the past month Willingness to participate and sign informed consent no limit no limit Both Severe asthma or bronchiectasis unrelated to chemical injury Class III or IV heart failure according to New York Heart Association criteria Renal failure Advanced liver disease Uncontrolled hypertension History of allergic reaction to hypertonic sodium chloride (7%) Tobacco/waterpipe use within the past 6 months Regular alcohol consumption Severe cognitive impairment Current ICU admission or requirement for mechanical ventilation Unwillingness to participate or sign informed consent J68.0 Bronchitis and pneumonitis due to chemicals, gases, fumes and vapors Treatment - Drugs Placebo Intervention group: Patients in the intervention group receive 7% sodium chloride solution (hypertonic saline) through an Omron NE-U22 mesh nebulizer device. The treatment protocol includes administering 4 ml of the solution twice a day (every 12 hours) for 8 weeks. Each nebulization session lasts about 10-15 minutes and patients are required to observe a 30-minute interval before and after meals and rinse their mouth after each use. The sterile solution used is provided by saha Pharmaceutical Company and all patients receive complete practical training on the correct use of the device before starting the intervention. Control group: Patients in this group receive 0.9% normal saline solution (placebo) with the same Omron NE-U22 mesh nebulizer device, with a completely similar protocol to the intervention group (4 ml, twice a day for 8 weeks). The placebo solution is prepared by the same manufacturer (saha) and is presented in containers that are completely similar in shape and packaging. All instructions for use, patient education, weekly follow-ups, and drug prohibitions in this group are also followed exactly the same as in the intervention group so that the specific effects of hypertonic saline can be properly assessed. Forced Expiratory Volume in 1 second (FEV1). Timepoint: Weeks 0, 4, and 8 post-intervention. Method of measurement: Standard spirometry using calibrated equipment. Respiratory Quality of Life Questionnaire Total Score. Timepoint: Weeks 0 and 8 post-intervention. Method of measurement: St. George Respiratory Quality of Life Questionnaire. Serum C-reactive protein (CRP) level. Timepoint: Weeks 0 and 8 post-intervention. Method of measurement: ELISA using standardized kits. Forced Vital Capacity (FVC). Timepoint: Weeks 0, 4, and 8 after intervention. Method of measurement: Standard spirometry using calibrated equipment. Peak Expiratory Flow (PEF). Timepoint: Weeks 0, 4, and 8 after intervention. Method of measurement: Spirometry. Frequency of coughing episodes. Timepoint: Weeks 0, 4, and 8 after intervention. Method of measurement: Patient-reported daily diary (visual analog scale). Sputum production volume. Timepoint: Days 1 and 3, weeks 0, 4, and 8 after intervention. Method of measurement: Graded container measurement (morning collection). Dyspnea. Timepoint: Weeks 0 and 8 after intervention. Method of measurement: Revised Medical Research Council Scale. Bagheiat-allah University of Medical Sciences Approved 2025-03-10 Research Ethics Committees of Baqiyatallah Hospital No. 7, South Sheikh Bahaei St., Molla Sadra St., Tehran Tehran Tehran Iran (Islamic Republic of)