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
The main purpose of this study is to evaluate the effectiveness of topical application of chamomile oil (Matricariachamomilla L.) compared with placebo for improving the symptoms (crying time) of infantile colic. In this double blind clinical trial done in 1395, 68 infants attending to a pediatric clinic in Sabzevar were randomly allocated into the intervention (A) and control (B) groups through block randomization method. Inclusion criteria: being at the age of 2 weeks to 4 months, presence of infantile colic symptoms and no systemic disease diagnosed by specialists, parental consent. In the intervention group, Chamomile oil was applied on the baby belly by mother's palms, three times a day and any time ten drops, for 14 days. In control group, Paraffin oil as a placebo was used in the same way as intervention group to homogenize the massage in both groups. Researcher, after educating how to use the drug / placebo to the parents, followed them by phone call or appointment in the clinic during the period of treatment. The effectiveness of Chamomile oil was evaluated based on the change in the frequency and duration of crying and infants’ sleep during 24 hours as the main outcome of study in the day before treatment, the first day, seventh and fourteenth day after treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017032818951N2
Registration date:2017-04-25, 1396/02/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-04-25, 1396/02/05
Registrant information
Name
Fereshteh Ghorat
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5558 0386
Email address
f-ghorat@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Sabzevar University of Medical Sciences
Expected recruitment start date
2016-12-28, 1395/10/08
Expected recruitment end date
2017-03-15, 1395/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
The effect of topical Chamomile oil in the treatment of infantile colic.
Purpose
Treatment
Inclusion/Exclusion 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.
Age
From 14 days old to 4 months old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Patients were placed in the intervention (A) and control (B) groups through block randomization method.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Medical campus, Sabzevar University of Medical Sciences, Daneshgah boulevard
City
Sabzevar
Postal code
9613873136
Approval date
2016-12-28, 1395/10/08
Ethics committee reference number
IR.MEDSAB.REC.1395.130
Health conditions studied
1
Description of health condition studied
Infantile colic
ICD-10 code
R10.4
ICD-10 code description
Other and unspecified abdominal pain
Primary outcomes
1
Description
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 outcomes
1
Description
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
2
Description
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
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric Clinic
Full name of responsible person
Doctor Hassan Salehipour, Neonatal fellowship
Street address
Dr Salehipour’s office, next to Heshmatieh Hospital, Bagh Melli
City
Sabzevar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Sabzevar University of Medical Sciences
Full name of responsible person
Doctor Mohammadzade
Street address
Vice Chancellor for research, Sabzevar University of Medical Sciences, Daneshgah boulevard
City
Sabzevar
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Sabzevar University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Behzad Afzali
Position
Medical Student
Other areas of specialty/work
Street address
Male student dormitory, Sabzevar University of Medical Sciences, Bahar Street
City
Sabzevar
Postal code
9597134889
Phone
+98 51 5254 6945
Fax
Email
behzadafzali88@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Doctor Hassan Salehipour
Position
Professor, Neonatal fellowship
Other areas of specialty/work
Street address
Heshmatieh Hospital, Bagh Melli
City
Sabzevar
Postal code
Phone
+98 51 4422 8500
Fax
Email
salehipoor45@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Behzad Afzali
Position
Medical student
Other areas of specialty/work
Street address
Male student dormitory, Sabzevar University of Medical Sciences, Bahar Street
City
Sabzevar
Postal code
9597134889
Phone
+98 51 5254 6945
Fax
Email
behzadafzali88@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)