The effect of Iranian cumin extract (Bunium persicum) on infantile colic

Phase 3

Recruiting

Conditions: Infantile colic.
Other and unspecified abdominal pain
R10.4

Registration Number: IRCT20230714058777N1

Lead Sponsor: Shahre-kord University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 80

Inclusion Criteria

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

Exclusion Criteria

failure to thrive
Recent use of antibiotics
age less than 3 weeks and more than 13 weeks
low birth weight
prematurity

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures