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IRCT20181208041882N13 IRCT 2023-10-14 Yazd University of Medical Sciences N-acetylcysteine in the treatment of diarrhea caused by rotavirus Evaluation of N-acetylcysteine efficacy compared to placebo in the treatment of diarrhea caused by rotavirus in children: a randomized, double-blind clinical trial. 2017-04-21 anticipated 64 Complete https://irct.ir/trial/68259 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 64 patients were randomly divided into two treatment groups (A and B). In order to randomize, the block random allocation method was used, in which 13 blocks of 5 were considered. The letters A and B. These permutations were generated with the help of Random software distribution software version 1. For this purpose, the list prepared by software No. 1 to 64 is in 13 blocks of five in general to implement this I want the software output to the first eligible person number 1 and I want to select the last person number 64, Blinding description: The patients, the physician, and the assessor of clinical symptoms will be all blinded to the intervention’s assignments during performing the study. In this way, the first executor of the sequence plan determines the allocation of individuals according to the order in which patients enter the study and puts N-acetyl cysteine and placebo syrups (They are the same in terms of packaging) in the same shape boxes for patient consumption. And identifies them with codes A or B. The student then delivers the appropriate medications to the patients. 3 Diarrhea caused by rotavirus. Intervention 1: Intervention group: Patients aged 6 months to 5 years with diarrhea caused by rotavirus receive 60 mg/kg N-acetylcysteine syrup daily (prepared at Yazd Faculty of Pharmacy) in 3 divided doses orally until the end of the diarrhea period. Intervention 2: Control group: Patients aged 6 months to 5 years with diarrhea caused by rotavirus receive daily placebo syrup (prepared in Yazd Pharmacy Faculty) in 3 divided doses orally until the end of the diarrhea period. Yes - There is a plan to make this available What will be shared: After nonrecognition, all data can be share When: 6 months after publication To whom: All of researchers Conditions: Nothing Where to obtain: Behrooz Heydari email: b.heydari@ssu.ac.ir How to obtain: Request your information by email. The data will be sent after a week. Comments:
public Behrooz Heydari
Shahid Sadoughi University of medical sciences, Shohadaye Gomnam Blvd, Alem Sq
Yazd Iran (Islamic Republic of) 8915173143 +98 35 3820 3410 b.heydari@ssu.ac.ir Yazd University of Medical Sciences scientific Behrooz Heydari
Shahid Sadoughi University of medical sciences, Shohadaye Gomnam Blvd, Alem Sq
Yazd Iran (Islamic Republic of) 8915173143 +98 35 3820 3410 b.heydari@ssu.ac.ir Yazd University of Medical Sciences Iran (Islamic Republic of) Rotavirus infection has been confirmed in patient. The age range of the patient is between 6 months and 5 years Absence of genetic or chronic diseases in patients Insensitivity to N-acetylcysteine Do not receive ibuprofen 6 months 5 years Both Patients who refer after 48 hours from the onset of diarrhea. Patients who receive ibuprofen. Hypersensitivity to N-acetylcysteine A08.0 Rotaviral enteritis Treatment - Drugs Treatment - Drugs Intervention group: Patients aged 6 months to 5 years with diarrhea caused by rotavirus receive 60 mg/kg N-acetylcysteine syrup daily (prepared at Yazd Faculty of Pharmacy) in 3 divided doses orally until the end of the diarrhea period. Control group: Patients aged 6 months to 5 years with diarrhea caused by rotavirus receive daily placebo syrup (prepared in Yazd Pharmacy Faculty) in 3 divided doses orally until the end of the diarrhea period. Investigation of duration and frequency of diarrhea. Timepoint: Days zero to seven. Method of measurement: Frequency of diarrhea per day and duration of diarrhea. Yazd University of Medical Sciences Approved 2017-02-15 School of Medicine- Shahid Sadoughi University of Medical Sciences Shahid Sadoughi University of Medical Science, Shohadaye Gomnam Blvd, Alem Sq Yazd Yazd Iran (Islamic Republic of)