Title : Examination of the effect of Cocoa powder on acute non-inflammatory diarrhea in children 1to 6 years old: double- blind randomized clinical trial

Determining the effect of cocoa powder on the recovery of acute diarrhea in children aged between 1 to 6 years

A double-blind, randomized, controlled, clinical trial with parallel group,phase3 on 140 patient. For randomization, "random allocation rule" method was used to assign A and B cards. Also, patients under and over2 years old are randomized separately.

This study will be done in Hajar Hospital. After the intervention, the severity of children's diarrhea in both groups will be measured before the intervention and then every 24 hours for five days. The recovery and etc are determined in two groups. Also, the stool consistency is evaluated based on the Bristol criteria. previous studies on cocoa consumption in children show that the consumption of 15 grams of cocoa has no complications. In the blinding method, both the patient and the person collecting the information are unaware of the type of medicine received by the patient.

Age 1 to 6 years acute diarrhea based on history and diagnosis absence of food and drug allergies Absence of underlying diseases Parental consent Absence of inflammatory bowel diseases The duration of the diarrhea less than 2 weeks Absence of bacterial diarrhea

The patients of both groups are treated for acute diarrhea according to the guidelines, the intervention and control groups are hydrated and receive zinc syrup 10 mg daily. Intervention group ,are given orally cocoa powder dissolved in 20 cc of cooled boiled water every 8 hours (children under 2 years old half of a teaspoon( 2-3 grams )and 2-6 years old a teaspoon (5 grams)).

frequency of defecation, stool consistency, recovery status, disease outcome, time from treatment to recovery, , temperature, dehydration,vomiting, frequency of vomiting, frequency of measurement

140 children suffering from acute non-inflammatory diarrhea referring to Hajar Hospital are randomized using the random allocation rule method, and a number is assigned to the patients, and then the cards that the patient's number is written on them are placed in an envelope in a shuffled manner. In this method, two color cards (red and blue or labeled A and B) are put into the envelope according to the sample volume, then the eligible people entered into the study randomly select one of the cards. After that they are categorized based on researcher definition. If the red or A card is taken, they will be entered in to the intervention group, and if the blue or B card is taken, they will be entered into the control group. Also, the patients are divided into two groups, which patients under 2 years and over 2 years old are randomized separately.

The method of blinding is such that the patient's companion, who is usually one of the parents, is unaware of the type of drug being used. Also, the person collecting the information is unaware of the type of medicine received by the patient.

To share the data and documents of this research, only the information related to the main outcome will be shared. Also, files that can be published and do not violate people's privacy will be published.

The data access period will start 6 months after the results are published.

Our data will only be available to researchers working in academic and scientific institutions.

. Our data will only be used for comparable study and peer review by other researchers.

All qualified individuals can collect data by referring to the project manager in order to acquire information. Contact information is available via email at st-miri@skums.ac.ir or the contact number00989138128690.

To receive information after sending the request, the requests will be reviewed within 10 days. If the above conditions are met, the information will be sent to the provided email within 30 days at most.