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IRCT20230514058188N1 IRCT 2023-06-13 Semnan University of Medical Sciences The effect of inhaled bromhexine on clinical symptoms and recovery of COVID-19 The effect of inhaled bromhexine on clinical and laboratory symptoms and COVID-19 2023-06-10 anticipated 78 Complete https://irct.ir/trial/70122 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomization, a block randomization method will be used. In the study, the allocation of samples is based on a random sequence provided by a statistical expert using statistical software. The block size will be 6. Meanwhile, the tool which is used for generating random-sequence blocks is a web-based software available at https://kitset.ir/numbers/random, Blinding description: The blinding of the study is such that the outcome assessor and biostatistician do not know the content of the intervention. For administration, the drug will be given to the clinical care provider for administration by mentioning the administration method. The outcome assessor records the outcome based on the patient's identity number according to the randomization table, and the data collected based on the number and mention of the first and second intervention is provided to the biostatistician for analysis. 3 Dyspnea. Intervention 1: Intervention group: Patients will receive bromhexine hydrochloride solution for inhalation (Mucolin ampoule 4 mg/2 ml, manufactured by Daru Pharmaceutical Company, Iran) 8 mg every 8 hours via a nebulizer mask for 7 days. Intervention 2: Control group: The patients will receive placebo (normal saline in a volume equal to inhaled bromhexine) every 8 hours through a nebulizer mask for 7 days. Yes - There is a plan to make this available What will be shared: All data will be presented anonymously. When: From the March of 2024 To whom: All researchers and workers in the medical sciences Conditions: The condition of using the data is that if it is used in scientific research, the name of the researchers of this project should be included. Where to obtain: If needed, can be available by contacting the person responsible for general inquiries, Dr. Mohammad Memarian via email: draria2014@gmail.com. How to obtain: First, with one of the mentioned methods, he informs the researcher what information he needs; Then, if possible, the information will be sent to them one week later. Comments:
public Mohammad Memarian
Kowsar hospital, Amin Street , Golestan Town
Semnan Iran (Islamic Republic of) 3519899951 +98 23 3142 2120 draria2014@gmail.com Semnan University of Medical Sciences scientific Mohammad Foroozeshfard
Kowsar hospital, Amin Street , Golestan Town
Semnan Iran (Islamic Republic of) 3519899951 +98 23 3142 2230 mff45@yahoo.com Semnan University of Medical Sciences Iran (Islamic Republic of) Patients with COVID-19 confirmed by PCR Patients with respiratory symptoms including caugh and dyspnea 18 years 90 years Both Need to mechanical ventilation Pregnancy or lactating Peptic ulcer R06 Abnormalities of breathing Treatment - Drugs Placebo Intervention group: Patients will receive bromhexine hydrochloride solution for inhalation (Mucolin ampoule 4 mg/2 ml, manufactured by Daru Pharmaceutical Company, Iran) 8 mg every 8 hours via a nebulizer mask for 7 days. Control group: The patients will receive placebo (normal saline in a volume equal to inhaled bromhexine) every 8 hours through a nebulizer mask for 7 days. Cough Severity. Timepoint: Before intervention and daily up to 7 day after intervention. Method of measurement: Visual Analogue Score. Arterial blood O2 saturation. Timepoint: Before intervention and daily up to 7 days after intervention. Method of measurement: Atrial blood gas measurment. Arterial blood carbon dioxide level. Timepoint: Before intervention and daily up to 7 days after intervention. Method of measurement: Atrial blood gas measurment. Semnan University of Medical Sciences Approved 2023-05-01 Ethics committee of Semnan University of Medical Sciences kosar hospital , Amin Street , Golestan Town , Semnan Semnan Semnan Iran (Islamic Republic of)