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IRCT20210312050687N1 IRCT 2021-05-14 Sabzevar University of Medical Sciences Evaluation the efficacy of the probiotic (Ramnuflor and sabular) on acute diarrhea in six months to five –year- old children referred to Heshmatieh Hospital. Evaluation the efficacy of the probiotic (Ramnuflor and sabular) on acute diarrhea in six months to five –year- old children referred to Heshmatieh Hospital. 2021-04-21 anticipated 180 Complete https://irct.ir/trial/54996 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: With the easy sampling method, the qualified patients referred to Heshmatieh Hospital are randomly divided into three groups (2 intervention and control) after selecting the sample. In this study, individuals were assigned to 3 groups using permutation block method. In this method, A represents the individual receiving the first intervention, B represents the individual receiving the second intervention, and C represents the individual in the control group. After entering the study, they will enter one of the three study groups using the six-block random method. A set of different modes, BBCAAC BCAACB, CCAABB خواهد will be prepared by a statistician. Using the letters A, B and C will be considered as a symbol of one of the three intervention groups. Each of the six codes is enclosed in a sealed envelope that cannot be read from the envelope. At the patients' visit, one of the envelopes is randomly selected and the patients are assigned to one of the study groups in the order of the letters mentioned in it. Therefore, by selecting the numbers from the table, the method of assigning a total of 180 people to the three groups will be determined, Blinding description: Using permutation block sampling method. Two-way blind The researcher (person implementing the project) and the people participating in the project are unaware of the type of treatment. 3 Acute diarrhea. Intervention 1: Intervention group: Group one. Group of children 6 months to 2 years receiving probiotic rhamnofluor. 45 people. This group receives standard ORS and Zinc fluid therapy along with 5 mm drops of Ramenofluor with a daily dose of 10 drops for 7 days. Raminoflor probiotic drops are from Farabiotic Company. Intervention 2: Intervention group:Group 2. Children 2 to 5 years old receiving subular probiotics. 45 people. This group, in addition to the standard fluid therapy, ORS and Zinc, receive one subular sachet daily for 7 days. Sapolar sac is from a parabiotic company that dissolves in liquid or solid food. Intervention 3: Control group:The group receiving routine diarrhea treatment included 45 children aged 6 months to two years and 45 children aged 2 to 5 years. This group receives standard ORS and Zinc fluid therapy. 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 Mehdi jalili akbarian
Asad abadi St,Heshmatieh Hospital sabzevar
Sabzevar Iran (Islamic Republic of) 9333156683 +98 51 4401 1600 jalilim56@yahoo.com Heshmatieh Hospital sabzevar scientific Mehdi jalili akbarian
Asad abadi St, Heshmatieh Hospital sabzevar
Sabzevar Iran (Islamic Republic of) 9333156683 +98 51 4401 1600 jalilim56@yahoo.com Sabzevar University of Medical Sciences Iran (Islamic Republic of) Clinical and laboratory symptoms based on chronic diarrhea. Diarrhea lasted more than 7 days. Be over 5 years old or under 6 months old The patient has a known case of immunodeficiency or cancer or a known underlying disease. Have an FTT or have a known chronic illness. Weight less than 3% percentile The patient has been taking probiotics for the past week Diarrhea accompanied by involvement or infection of other examined organs. Severe electrolyte disturbances such as hypernatremia, sodium betasherazine 145 and hypocalcemia, potassium less than 3.5 Dehydration percentage more than 10% 6 months 5 years Both Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Group one. Group of children 6 months to 2 years receiving probiotic rhamnofluor. 45 people. This group receives standard ORS and Zinc fluid therapy along with 5 mm drops of Ramenofluor with a daily dose of 10 drops for 7 days. Raminoflor probiotic drops are from Farabiotic Company. Intervention group:Group 2. Children 2 to 5 years old receiving subular probiotics. 45 people. This group, in addition to the standard fluid therapy, ORS and Zinc, receive one subular sachet daily for 7 days. Sapolar sac is from a parabiotic company that dissolves in liquid or solid food. Control group:The group receiving routine diarrhea treatment included 45 children aged 6 months to two years and 45 children aged 2 to 5 years. This group receives standard ORS and Zinc fluid therapy. Number of times diarrhea per day. Timepoint: For 7 days in a row. Method of measurement: interview. Sabzevar University of Medical Sciences Approved 2021-03-10 Ethics committee Sabzevar University of Medical Sciences Asad abadi St.olom pezeshki sabzevar Sabzevar Razavi Khorasan Iran (Islamic Republic of)