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IRCT20220302054167N1 IRCT 2022-04-29 Hamedan University of Medical Sciences The effect of acetylcysteine and bromhexine on the improvement and prevention of hospitalization in outpatients with Covid-19 Evaluation of the efficacy of N-acetylcysteine and Bromhexine compared with Standard Care in Preventing Hospitalization of Outpatients with COVID-19: A double-blind randomized clinical trial 2022-03-10 anticipated 225 Complete https://irct.ir/trial/62333 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: We will use a six-block randomized method for patient allocation. Sheets will be prepared on which two sheets of letters "A", two sheets of "B" and two sheets of "C" will be written. These will be mixed up and placed in the desk drawer. When the patient is eligible, a card is randomly drawn and the patient is placed in groups "A", "B", "C". Notably, a particular card is not returned to the drawer until all six cards have been drawn once. This process of random allocation continues for the next six patients until the desired sample size of 225 patients is obtained, Blinding description: Both intervention and control groups will receive injectable drugs with the same appearance, which are marked with a code, and the patient and the examiner will be unaware of the type of drug used by the patients. Therefore, the study will be conducted in a double-blind manner. 3 covid-19. Intervention 1: Intervention group: The first group was a group of patients taking oral acetylcysteine(Hakim company) 600 mg twice daily for 5 days. Intervention 2: Intervention group: The second method is for patients who take 8 mg of bromhexine tablets (Tolid Daroo) three times a day for 5 days. Intervention 3: Control group: They will receive only the usual treatments prescribed for the other two groups. All patients received naproxen 250 mg twice daily for five days, famotidine 20 mg once daily for ten days, vitamin D 50,000 per week for four weeks, and vitamin C 1,000 mg daily. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentifiable individuals When: Six months after the results were published To whom: Researchers working in academic institutions Conditions: For further research purposes and analysis Where to obtain: Anahita Eslami Ghayour, Hamedan University of medical science How to obtain: Official letter to researchers Comments:
public Anahita Eslami-Ghayour
No. 25, Jihad Alley, 18 meters from Fajr, Ostadan St.
Hamedan Iran (Islamic Republic of) 6516866818 +98 81 3824 5383 anahitaeslami1995@gmail.com Hamedan University of Medical Sciences scientific Fariba keramat
Pasteur Crossroads, Farshchian Educational and Medical Center, Hamedan
hamedan Iran (Islamic Republic of) 6516866818 +98 81 3827 4184 keramat@ umsha.ac.ir Hamedan University of Medical Sciences Iran (Islamic Republic of) Outpatients with Covid-19 symptoms after positive Covid-19 RT-PCR test Oxygen level 98-92% 18 years 80 years Both • Dissatisfaction of the patient or their relatives to participate in the study • Pregnancy and lactation Evidence of pulmonary involvement and the need for hospitalization or referral to an infectious disease specialist Prohibition of N-acetylcysteine and bromhexine as a history of allergy and anaphylactic shock U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: The first group was a group of patients taking oral acetylcysteine(Hakim company) 600 mg twice daily for 5 days Intervention group: The second method is for patients who take 8 mg of bromhexine tablets (Tolid Daroo) three times a day for 5 days. Control group: They will receive only the usual treatments prescribed for the other two groups. All patients received naproxen 250 mg twice daily for five days, famotidine 20 mg once daily for ten days, vitamin D 50,000 per week for four weeks, and vitamin C 1,000 mg daily. Blood Oxygen. Timepoint: At the beginning of the study (before the intervention) and 7, 14 days. Method of measurement: pulse oximeter. Cough. Timepoint: At the beginning of the study (before the intervention) and 7, 14 days. Method of measurement: questionnaire. Shortness of breath. Timepoint: At the beginning of the study (before the intervention) and 7, 14 days. Method of measurement: questionnaire. Sore throat. Timepoint: At the beginning of the study (before the intervention) and 7, 14 days. Method of measurement: questionnaire. Time to recover from the desired symptoms. Timepoint: daily. Method of measurement: questionnaire. Duration of hospitalization. Timepoint: At the beginning of the study (before the intervention) and 7, 14 days. Method of measurement: questionnaire. Death. Timepoint: At the beginning of the study (before the intervention) and 7, 14 days. Method of measurement: questionnaire. Hamedan University of Medical Sciences Approved 2022-03-04 Ethics Committee of Hamadan University of Medical Sciences Research Ethics Committee, Vice Chancellor for Research and Technology, Hamadan University of Medical Sciences,Shahid Fahmideh Blvd. Hamedan Hamadan Iran (Islamic Republic of)