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IRCT20230714058777N1 IRCT 2023-09-02 Shahre-kord University of Medical Sciences The effect of Iranian cumin extract (Bunium persicum) on infantile colic Examination of the effect of Iranian cumin extract (Bunium persicum) on infantile colic: A randomized double-blind trial 2023-09-11 anticipated 80 Complete https://irct.ir/trial/71549 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Infantile colic. Intervention 1: Intervention group:in addition to relaxation techniques, the intervention group will receive 0.5 mL of oral extract of Bunium persicum 4 times a day in the form of oral drops (provided by Barij Company) for two weeks. Intervention 2: Control group:The control group will not be deprived of the standard treatment, which is relaxation techniques. Relaxation techniques includeing making soothing sounds or singing songs, using slow and rhythmic shaking movements, walking, and using mild vibration-like movements such as the movements of cars are taught to parents at the beginning of the study.In addition, the control group will receive placebo in the form of drops with the same color and smell as cumin extract. Yes - There is a plan to make this available What will be shared: Checklists completed by mothers include individual data that can be published after de-identification When: The start of the period of access to data and documentation files will be 6 months after the results are published To whom: 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. Conditions: The data obtained from the study can be used in order to help make the right medicine to control infant colic. Where to obtain: Contact the scientific officer of the project via email at talakesh.h@skums.ac.ir How to obtain: 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. Comments:
public Amin Amini
Parastar st.
Shahrekord Iran (Islamic Republic of) 8816854633 009838132252416 st-amini.a@skums.ac.ir Shahre-kord University of Medical Sciences scientific Hassan Talakesh
Parastar st.
Shahrekord Iran (Islamic Republic of) 88168854633 +98 38 3225 2416 talakesh.h@skums.ac.ir Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Infantile colic based on wessel`s criteria (paroxysms of crying episodes; lasting for more than 3h in a day; occuring three or more days per week for at least three weeks) diagnosed by pediatrician age: 3-13 weeks Gastational age: more than 37 weeks at birth weight: more than 2500 gr at birth Absence of underlying diseases or congenital disorders No antibiotic use in the last two weeks 21 days 91 days Both failure to thrive Recent use of antibiotics age less than 3 weeks and more than 13 weeks low birth weight prematurity R10.4 Other and unspecified abdominal pain Treatment - Drugs Placebo Intervention group:in addition to relaxation techniques, the intervention group will receive 0.5 mL of oral extract of Bunium persicum 4 times a day in the form of oral drops (provided by Barij Company) for two weeks. Control group:The control group will not be deprived of the standard treatment, which is relaxation techniques. Relaxation techniques includeing making soothing sounds or singing songs, using slow and rhythmic shaking movements, walking, and using mild vibration-like movements such as the movements of cars are taught to parents at the beginning of the study.In addition, the control group will receive placebo in the form of drops with the same color and smell as cumin extract. The average duration of crying in infant. Timepoint: the beginning of the study and 7, 14, 21 and 28 days after the start of the study. Method of measurement: check list. The number of times the infant cries. Timepoint: the beginning of the study and 7, 14, 21 and 28 days after the start of the study. Method of measurement: checklist. Duration of sleep. Timepoint: the beginning of the study and 7, 14, 21 and 28 days after the start of the study. Method of measurement: check list. Number of defications. Timepoint: the beginning of the study and 7, 14, 21 and 28 days after the start of the study. Method of measurement: chrcklist. Age. Timepoint: the beginning of the study. Method of measurement: the history. Sex. Timepoint: the beginning of the study. Method of measurement: the history. Birth weight. Timepoint: the beginning of the study. Method of measurement: the history. Shahre-kord University of Medical Sciences Approved 2023-05-31 Ethics committee of Shahrekord University of Medical Sciences Ayatollah Kashani St. Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)