]>
IRCT20180624040213N3 IRCT 2022-02-01 Babol University of Medical Sciences Effect of montelukast in treatment of gastroenteritis MGE Evaluation efficacy of montelukast in children gastroenteritis 2021-12-11 anticipated 60 Complete https://irct.ir/trial/59267 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research. 1 Diarrhea. Intervention 1: Control group: All patients in the control group receive standard gastroenteritis treatment. Routine treatment of gastroenteritis includes serum therapy and zinc sulfate syrup). Receive routine treatment (ORS and zinc) for 14 days. Intervention 2: Intervention group: In addition to routine treatment (ORS and zinc), they receive Montelukast for 14 days. in the treatment group, Montelukast, is prescribed at a dose of 5 mg once a day for 14 days. 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 There is no more information
public Hossein Najafzadehvarzi
Medical faculty, Babol University of Medical Sciences, Ganjafrooz street, Kargar squer, Babol
Babol Iran (Islamic Republic of) 4719765574 +98 11 3247 6421 najafzadehvarzi@gmail.com Babol University of Medical Sciences scientific Hossein Najafzadehvarzi
Medical faculty, Babol University of Medical Sciences, Ganjafrooz street, Kargar squer, Babol
Babol Iran (Islamic Republic of) 4719765574 +98 11 3247 6421 najafzadehvarzi@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) 1. All patients with gastroenteritis, at any age 2 to 12 years and of both sexes, boys and girls are included in the study. 2. Patients with incurable disease or dangerous disease other than gastroenteritis. 3. Satisfaction of patients or their trustees (informed consent will be obtained from patients or patient trustees to participate in the study.) 2 years 12 years Both Patients who develop a disease other than gastroenteritis during the study or find drug allergies Refrain from collaborating with the research team during the study or refrain from taking medication and clinical examinations according to the study method. Treatment - Drugs Treatment - Drugs Control group: All patients in the control group receive standard gastroenteritis treatment. Routine treatment of gastroenteritis includes serum therapy and zinc sulfate syrup). Receive routine treatment (ORS and zinc) for 14 days. Intervention group: In addition to routine treatment (ORS and zinc), they receive Montelukast for 14 days. in the treatment group, Montelukast, is prescribed at a dose of 5 mg once a day for 14 days. Measurement of serum interleukin level 13. Timepoint: Measurement of serum interleukin level 13 at the beginning of the study and 14 days after consumption of Montelukast. Method of measurement: Analysis of covariance (ANCOVA) will be used to evaluate the effect of montelukast on IL13 (before and after treatment) in both groups. Frequency of diarrhea and abdominal pain in the study of the effectiveness of Montelukast in the treatment of pediatric gastroenteritis. Timepoint: Evaluation of abdominal pain and frequency of diarrhea and measurement of serum level of interleukin 13 at the beginning of the study and 14 days after taking Montelukast. Method of measurement: How to measure the frequency of diarrhea excretion according to Bristol criteria, Evaluation of abdominal pain based on criteria Visual Analogue. Babol University of Medical Sciences Approved 2021-08-24 Ethics committee of Islamic Azad University, Ayatollah Amoli Branch Mazandaran Babol Ayatollah Khamenei St. Ershad 15 Babol Mazandaran Iran (Islamic Republic of)