Survey the Cordia myxa syrup effect in reducing the severity and duration of diarrhea in hospitalized children due to gastroenteritis

The purpose of this study is to investigate the effect of this syrup on reducing the intensity and duration of diarrhea in children hospitalized due to gastroenteritis.

Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 140 patients. A table of random numbers was used for randomization.

Study in Abuzar hospital of Ahvaz in 2 control and intervention groups are treated with the desired syrup and placebo and are examined by the questionnaire of the desired variables.

Inclusion criteria:Children from 12 months to 96 months, Suffering from acute gastroenteritis, Not receiving drug treatment before entering the study Exclusion criteria:Patients with severe dehydration, Presence of abnormal findings in stool test such as blood, Existence of surgical problem such as acute abdominal surgery, Suffering from another disease or receiving another drug during the study, Non-adherence to the treatment protocol or leaving the treatment before complete recovery, Frequent vomiting and drug intolerance, Patient withdrawal from participating in the study

Giving corda mixa syrup compared to placebo

diarrhea, nausea, heartache, restlessness, fever, chills, sweating, headache, respiratory symptoms, the number of times of vomiting, the number of times of diarrhea per day, the number of days that the diarrhea lasted, and the volume and consistency of stool.

In this study, we will use the permutation block randomization method. Blocking is usually used in order to balance the number of samples assigned to each of the studied groups. This feature helps the researchers so that the number of samples assigned to each of the studied groups is equal in cases where intermediate analyzes are needed during the sampling process. In this two-group clinical trial, block sizes of 4, 6, and 8 have been considered (in this method, the number of people assigned to each group in the blocks is equal). The randomization tool is also used from random sequence generation software (Random allocation software), which in addition to simple randomization, these random sequence generation software are capable of generating random sequence by block method. For concealment, we use Concealment Allocation, which refers to the method used to perform a random sequence on the participants in the study, so that the allocated group is not known before the allocation of the individual. By using opaque, sealed, numbered sequentially envelopes, in this method, each random sequence created is recorded on a card, and the cards are placed inside the envelopes in order. They are placed. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of registration of participants, based on the order of entry of qualified participants into the study, one of the envelopes will be opened and the assigned group of that participant will be revealed.

The participants who received the syrup and the health care personnel (nurses) who are responsible for taking care of the patients and provide the syrup to the patients without knowing whether the given syrup is a placebo or the syrup have participated in the research, but the main researcher, the officials Data collection and outcome assessors and, to a lesser extent, the Data Saftey and Monitoring Board and those preparing the draft article knew what syrup each person received.

All data is potentially shareable after de-identifying individuals

The access period starts after the results are printed

The possibility of access for researchers working in academic and scientific institutions and people working in the industry

For use and reference in other researches

Mana Hafizi Birgani Children's specialist assistant +989166131934

After confirming the access, they will get access within 24 to 48 hours