Protocol summary

Summary
Objective: To determine the efficacy of topical Chamomile oil, compared with placebo, on infantile colic. Inclusion criteria: Infants who had Wessel factor; Full term ; Birth Weight 2500-4000 gram; Breast Milk Feeding; Filling Consent Form; Age: 2-13 week. Exclusion criteria: Failure to thrive; Lactose intolerance and Allergic to Milk; Use Of Antibiotic; Use Of Formula; Acute or Chronic disease; Skin allergy to oils; failure in conducting the intervention correctly. Design: Randomize, Triple blind clinical study was peformed on 102 breastfed infants, who were coming to Children medical center or Traditional Iranian Medicine clinic. At the first, their mothers 4 days, note the hours of the cry. If they had wessle's criteria (episodes of fussy crying lasted _3 hours a day and episodes_3 days in the 1 week) and written informed consent form, enrolled in this project. Randomize: Colicy infants were randomly assigned to reccive Chamomile oil or placebo. The bottles were coded and blinded by the pharmacist for the participants and physicians and methodologist. both groups give Simethicone (5-10 drops 3/day). The mother is taught, 2drops of oil spills on the children's arm and wait 3 hours, in the absence of complication, 5-7 drops of oil spill on the abdomen, below the ribs to the lower abdomen and 5-7 drops both sides of the vertebral column , and spread to be completely impregnated with oil. This is at least 4 times as needed up to 6 times a day. parents were asked to fill in a structured diary to record the daily crying time (minute) , stool characteristics and frequency, and any adverse effect observed on each days of the study. Duration of intervention is 7 days. primary outcome is duration of infantile crying in 24 hours: 4 days a week before intervention and for 7 days in the intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016111530903N1
Registration date: 2017-03-03, 1395/12/13
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-03-03, 1395/12/13
Registrant information
Name
Fatemeh Mohamadi Sormeh
Name of organization / entity
School of Traditional Medicine, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8899 3656
Email address
f-mohamadis@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Tehran University of Medical Sciences
Expected recruitment start date
2017-04-04, 1396/01/15
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of topical Chamomile oil (Matricaria chamomilla), an Iranian traditional medicine, compared with placebo, on infantile colic: Triple blind clinical trial
Public title
The efficacy of Chamomile oil on infantile colic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Infants who had Wessel factor; Full term ; Birth Weight 2500-4000 gram; Breast Milk Feeding; Filling Consent Form; Age: 2-13 week. Exclusion criteria: Failure to thrive; Lactose intolerance and Allergic to Milk; Use Of Antibiotic; Use Of Formula; Acute or Chronic disease; Skin allergy to oils; failure in conducting the intervention correctly.
Age
From 14 days old to 3 months old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 102
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran Univercity of Medical Science
Street address
Qods Streeet, Bolvar Keshavarz
City
Tehran
Postal code
Approval date
2017-01-24, 1395/11/05
Ethics committee reference number
IR.TUMS.VCR.REC.1395.1531

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
Duration of infantile crying in 24 hours for7days
Timepoint
4days a week before intervention and 7days in the intervention time
Method of measurement
recording of crying time by mother

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In addition of Simethicon 5-7 drops both sides of the vertebral column , and spread to be completely impregnated with oil. This is at least 4 times as needed up to 6 times a day is done for 7 days
Category
Treatment - Drugs

2

Description
Control group: In addition of Simethicon 5-7 drops both sides of the vertebral column , and spread to be completely impregnated with oil. This is at least 4 times as needed up to 6 times a day is done for 7 days
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
School of Traditional medicine, Tehran University of Medical Science
Full name of responsible person
Fatemeh Mohamadi Sormeh
Street address
Sarparast St, Taleghani St, ValiAsr Blvd.
City
Tehran

2

Recruitment center
Name of recruitment center
Children Medical Center Hospital
Full name of responsible person
Dr Fatemeh Mohamadi Sormeh
Street address
Garib St, Bolvar Keshavarz
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, school of Traditional Medicine,Tehran University of Medical Science
Full name of responsible person
Dr Roja Rahimi
Street address
Sarparast St, Taleghani St, ValiAsr Blvd.
City
Tehran
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, school of Traditional Medicine,Tehran University of Medical Science
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
School of Traditional medicine, Tehran University of Medical Science
Full name of responsible person
Fatemeh Mohamadi Sormeh
Position
Phd candidate of Traditional Medicine
Other areas of specialty/work
Street address
Sarparast St, Taleghani St, ValiAsr Blvd.
City
Tehran
Postal code
1449614353
Phone
+98 21 6697 6527
Fax
Email
DR.F.MOHAMADI.S@GMAIL.COM
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Traditional medicine, Tehran University of Medical Science
Full name of responsible person
Dr Malihe Tabarraie Arani
Position
Phd of Traditional Medicine
Other areas of specialty/work
Street address
Sarparast St, Taleghani St, ValiAsr Blvd.
City
Tehran
Postal code
1449614353
Phone
+98 21 6697 6527
Fax
Email
DR.MTABARRAI@YAHOO.COM
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Traditional medicine, Tehran University of Medical Science
Full name of responsible person
Fatemeh Mohamadi Sormeh
Position
Phd candidate of Traditional Medicine
Other areas of specialty/work
Street address
Sarparast St, Thaleghani St, ValiAsr Blvd
City
Tehran
Postal code
1449614353
Phone
+98 21 6697 6527
Fax
Email
DR.F.MOHAMADI.S@GMAIL.COM
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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