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IRCT20240508061709N1 IRCT 2024-05-12 Ghoum University of Medical Sciences Gastro-fix powder efficacy in pediatric acute gastroenteritis Evaluation of Gastro-fix powder efficacy in pediatric acute gastroenteritis 2024-05-21 anticipated 160 Complete https://irct.ir/trial/76718 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be assigned to two groups A (standard treatment + Gastro-Fix powder) or B (standard treatment + placebo powder) based on the pattern determined in the R software blockrand package. Random allocation will be done in decimal blocks to obtain groups of similar size. The sequence will be hidden until the patients are determined, Blinding description: Special codes are assigned to patients and provided to therapists. Neither the patient nor the therapist knows whether the oral medicine that is given to the patient in addition to the standard treatment is Gastrofix powder or a placebo. Both drugs are made in powder form by Fasca Co. 3 Gastroenteritis. Intervention 1: Intervention group: patients will receive Gastro-fix, 9 g/kg in three divided doses per day. Intervention 2: Control group: patients will receive regular formula 9 g/kg in three divided doses per day. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals. When: The access period starts from September 2025. To whom: It will be available only to researchers working in academic and scientific institutions. Conditions: A letter to the Vice-Chancellor of Medical Sciences Research, Qom Where to obtain: Fahime Alishavandi 09173071474 How to obtain: One Month Comments:
public Fahime Aliahavandi
Hazrat Masoumeh Hospital, Zainuddin Square
Qom Iran (Islamic Republic of) 3713649373 +98 25 3162 5224 F.aalishavandi24@gmail.com Ghoum University of Medical Sciences scientific Fahime Alishavandi
Hazrat Masoumeh Hospital, Zainuddin Square, Qom
Qom Iran (Islamic Republic of) 3713649373 +98 25 3162 5224 F.aalishavandi24@gmail.com Ghoum University of Medical Sciences Iran (Islamic Republic of) formula feed children with acute gastroenteritis aged 6 to 24 months 6 months 2 years Both dysentery chronic diarrhea severe dehydration malnutrition underlying diseases (such as inflammatory bowel disease; necrotizing enterocolitis; immune deficiency, etc.) Lack of parental consent A08.4 Viral intestinal infection, unspecified Treatment - Other Treatment - Other Intervention group: patients will receive Gastro-fix, 9 g/kg in three divided doses per day. Control group: patients will receive regular formula 9 g/kg in three divided doses per day. Length of hospitalization. Timepoint: after intervention. Method of measurement: Number of hospitalization days. Frequency of diarrhea. Timepoint: after intervention. Method of measurement: Number. Percentage of dehydration. Timepoint: Before and after the intervention. Method of measurement: The percentage of dehydration according to the dehydration scale of the World Health Organization. Stool consistency. Timepoint: before and after intervention. Method of measurement: stool consistency score. Ghoum University of Medical Sciences Approved 2024-03-16 Ethics Committee of Qom University of Medical Sciences Qom, Iran Qom Ghoum Iran (Islamic Republic of)