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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230714058777N1

Enrollment

Registered

2023-09-02

Start date

2023-09-11

Completion date

Unknown

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infantile colic. Other and unspecified abdominal pain

Interventions

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

Eligibility

Sex/Gender

All

Age

21 Days to 91 Days

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmin Amini

Shahre-kord University of Medical Sciences

st-amini.a@skums.ac.ir009838132252416

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026