Examination of the effect of Iranian cumin extract (Bunium persicum) on infantile colic: A randomized double-blind trial

Determining and comparing the effect of Iranian cumin extract (Bunium persicum) on infant colic between control and intervention groups

A randomised, double blind Clinical trial with a control group, with parallel groups, phase 3 on 80 patients. For randomization, random allocation rule was used to assign red and blue cards.

This randomized double-blind clinical trial will be conducted on children with colic referred to Imam Ali Pediatric Clinic in 1402. The study will be double-blind so that the researcher and parents will not be aware of the grouping (intervention or control).At the beginning of the study, a written consent form will be obtained from the parents after providing explanations. The intervention group will be treated with relaxation techniques and cumin extract, and the control group will be treated with relaxation techniques and placebo. A checklist regarding the child's symptoms will be provided to the parents to record the infant's symptoms during the study. At the end, the coded data will be entered into the spss 22 table and will be analyzed.

inclusion criteria: previously diagnosed infantile colic; No antibiotic use in the last two weeks; Absence of underlying diseases or congenital disorders exclusion criteria: No relevant diagnosis of colic and no meeting of the inclusion criteria

In addition to calming techniques, the intervention group will receive 0.5 mL of Bunium persicum oral extract daily in the form of drops (obtained from Barij Essential Oil Company) for two weeks. The control group will not be deprived of the standard treatment, which is relaxation techniques, and will receive a placebo with the same color and smell as Iranian cumin extract.

duration of crying; times of crying; sleep duration; Number of bowel movements

The researcher assigns a number to each patient using the random allocation rule method and then puts the cards on which the patient's number is written in an envelope in a random order. In this method, according to the sample volume, two sets of card with different colors with the same number equal to the total volume of the sample are put inside the envelope, then the eligible people entered into the study are randomly assigned to a color coded card from the envelope. According to the researcher's definition, if the red card is taken, they will enter the intervention group, and if the blue card is taken, they will enter the control group.

In our method of blinding, the patient's companion, who is usually one of the parents, is unaware of the type of drug used. Also, the person collecting the information is unaware of the type of drug received by the patient. Placebo has the same color and smell as Bunium extract. The extract will be provided by Barij Company in the same form and packaging in a coded form, under the supervision of a pharmacology expert.

Checklists completed by mothers include individual data that can be published after de-identification

The start of the period of access to data and documentation files will be 6 months after the results are published

The data obtained from the study will be accessible to researchers working in academic and scientific centers as well as people working in the pharmaceutical industry.

The data obtained from the study can be used in order to help make the right medicine to control infant colic.

Contact the scientific officer of the project via email at talakesh.h@skums.ac.ir

After correspondence with the scientific officer of the project through the e-mail address talakesh.h@skums.ac.ir, within two weeks after checking the purpose of data access, their request will be answered.