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The effect of topical Chamomile oil in the treatment of infantile colic.

Evaluation of the effectiveness of chamomile oil (Matricariachamomilla L.) topical application, as a supplement therapy, compared with placebo in the improvement of infantile colic symptoms (crying time): a randomized controlled clinical trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT2017032818951N2
Enrollment
68
Registered
2017-04-25
Start date
2016-12-28
Completion date
Unknown
Last updated
2018-02-22

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: In the intervention group, ten drops of Chamomile oil was rubbed on the baby’s belly by mother's palms, 15 times clockwise and 15 times counter-clockwise, three times a day, for 14 con
Treatment - Drugs
Placebo
In the intervention group, ten drops of Chamomile oil was rubbed on the baby’s belly by mother's palms, 15 times clockwise and 15 times counter-clockwise, three times a day, for 14 consecutive days.
In the control group, ten drops of Paraffin oil was rubbed on the baby’s belly by mother's palms, 15 times clockwise and 15 times counter-clockwise, three times a day, for 14 consecutive days.

Sponsors

Vice Chancellor for research of Sabzevar University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Days to 4 Months

Inclusion criteria

Inclusion criteria: Inclusion criteria: infants with infantile colic (based on the criteria Wessel and a pediatrician); at the age of two weeks to four months; term infants (gestational age more than 37 weeks); infants with birth weight more than 2500 gr; absence of underlying diseases and congenital disorders. Exclusion criteria: failure to thrive (according to growth curves); major medical conditions (immune deficiency, growth and development retardation, genetic disorders); presence of rash in the area of topical medication therapy.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Infant crying time (in minutes) in 24 hours. Timepoint: The day before the treatment, the first day, the seventh and fourteenth day after treatment. Method of measurement: Register crying time in infants in terms of minutes per day in the form of journaling, maternal infant.

Secondary

MeasureTime frame
Infant sleep duration in minutes in 24 hours. Timepoint: The day before the treatment, the first day, the seventh and fourteenth day after treatment. Method of measurement: Register infant sleep duration in minutes per day in the form of journaling, maternal infant.;Number of infant's crying in 24 hours. Timepoint: The day before the treatment, the first day, the seventh and fourteenth day after treatment. Method of measurement: Register number of infant crying during the day and in the form of journaling, maternal infant.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactBehzad Afzali

Sabzevar University of Medical Sciences

behzadafzali88@yahoo.com+98 51 5254 6945

Outcome results

None listed

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