The objective of the present randomized control clinical and double-blind trial is to compare the effect of topical application chamomile and calendula on the recovery rate of diaper dermatitis.
90 infants (aged 6 through 12 month) with diaper dermatitis randomized to receive topical calendula ointment (n=45) or chamomile ointment (n=45).
Children in each group were treated with the respective topical three times a day for a period of 3 days. Parents were instructed to wash diaper area with lukewarm water during diaper change and—after drying—treat the area only with the administered medication. The severity and extent of dermatitis was graded at baseline as well as days 3 and 7 of study using a 5-point scale (from 0 to 4). Then recovery of diaper dermatitis will calculate and compare in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201302284617N4
Registration date:2013-04-07, 1392/01/18
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-04-07, 1392/01/18
Registrant information
Name
Mahnaz Jabraeili
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
jabraeilim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Council of Tabriz University of Medical Sciences
Expected recruitment start date
2013-05-10, 1392/02/20
Expected recruitment end date
2013-10-22, 1392/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of topical application Chamomile and Calendula on the recovery rate of diaper dermatitis
Public title
Comparison the effect of topical application Chamomile and Calendula on diaper dermatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: infants aged among 6-12 months; patients who had not secondary infections and treated with corticosteroids or had not
sensitivity to any of the study medications.
Exclusion criteria: there is known diseases that require to special treatment; using other drugs for healing diaper dermatitis; using antibiotics during research and there is fungal dermatitis by exploration of physician.
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Deputy of research, Tabriz University of Medical Sciences
Street address
Deputy of Research, Tabriz University of Medical Sciences ,Golgasht street , Tabriz
City
Tabriz
Postal code
977-5138947
Approval date
2013-02-16, 1391/11/28
Ethics committee reference number
5/4/10785
Health conditions studied
1
Description of health condition studied
Diaper rash
ICD-10 code
l 22
ICD-10 code description
Diaper [napkin] dermatitis
Primary outcomes
1
Description
Severity of dermatitis
Timepoint
Baseline, days 5 and 10 of study
Method of measurement
5-point scale for severity of diaper dermatitis
Secondary outcomes
1
Description
Dermatitis Extent- sid effect
Timepoint
Baseline, days 5 and 10 of study
Method of measurement
Checklist
Intervention groups
1
Description
Control group: In the control group, is used 1.5% Calendula. Parents were instructed to wash diaper area with lukewarm water during diaper change and—after drying—treat the area only with the administered medication that they were not informed of thetype.The severity and Extent of dermatitis was graded at baseline as well as days 3 and 7 of study.
Category
Treatment - Drugs
2
Description
In the Intervention group, is used 3% chamomile; parents were instructed to wash diaper area with lukewarm water during diaper change and—after drying—treat the area only with the administered medication that they were not informed of the type. The severity and Extent of dermatitis was graded at baseline as well as days 3 and 7 of study.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ardabil Social Security Hospital
Full name of responsible person
Zahra Afshari
Street address
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Council of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Ostad Rahimi
Street address
Research Council of Tabriz University of Medical Sciences, Golgasht street , Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Council of Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Zahra Afshari
Position
MSc student
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Shariatii street, Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 45 1663 3416
Fax
Email
afshari78@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahnaz Jabraeili
Position
Faculty member, Master of science
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Shariati street, Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 41 1479 6770
Fax
Email
jabraeilim@tbzmed.ac.irjebreilim@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahnaz Jabraeili
Position
Master of science, Faculty member
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Shariati street,Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 41 1479 6969
Fax
Email
jabraeilim@tbzmd.ac.irjebreilim@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)