Evaluation effect of topical application of magnesium 2% , althaea officinalis 5% and althea officinalis 5% plus magnesium 2% Cream containing compare with calendula cream in the treatment of Diaper Dermatitis in Children.
The aim of this study was the effect of topical application of magnesium 2% , althaea officinalis 5% and althea officinalis 5% plus magnesium 2% Cream containing compare with calendula cream in the treatment of Diaper Dermatitis in Children referred to Pediatric and neonatal ward in Hajar Hospital of Shahrekord. This study is a double blind clinical trial, placebo-controlled, single-center is 128 children referred to pediatric who fulfilled inclusion criteria: diagnosis of diaper rash; children under two years. Exclusion criteria: other diseases such as lupus divided into 4 groups of 32, first group used althaea officinalis 5% cream containing and the second group cream containing magnesium 2% and the third group combines althaea officinalis5% and magnesium 2%and the fourth group receive Calendula Cream, 3 times a day after changing diaper in place. Follow-up treatment is performed on days 3 and 7.Patients with improved diaper rash symptoms are considered to be responding to treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016041710222N6
Registration date:2016-05-29, 1395/03/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-29, 1395/03/09
Registrant information
Name
Zahra Keivani
Name of organization / entity
Shahrekord University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1222 0016
Email address
keivani@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation effect of topical application of magnesium 2% , althaea officinalis 5% and althea officinalis 5% plus magnesium 2% Cream containing compare with calendula cream in the treatment of Diaper Dermatitis in Children.
Public title
Effect of topical application of magnesium 2% , althaea officinalis 5% and althea officinalis 5% plus magnesium 2% Cream containing compare with calendula cream in the treatment of Diaper Dermatitis in Children.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: diagnosis of diaper rash; children under 2 years. Exclusion Criteria: other diseases with diaper rash such as lupus.
Age
To 2 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
128
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahrekord University of Medical Sciences
Street address
Kashani street, shahrekord university of medical sciences, shahrekord
City
Shahrekord
Postal code
Approval date
2016-01-17, 1394/10/27
Ethics committee reference number
IR.SKUMS.REC.1394.93
Health conditions studied
1
Description of health condition studied
diaper rash
ICD-10 code
l22
ICD-10 code description
Diaper [napkin] dermatitis
Primary outcomes
1
Description
diaper rash symptom
Timepoint
Baseline and two weeks later
Method of measurement
observation
Secondary outcomes
empty
Intervention groups
1
Description
, first group used althaea officinalis 5% cream containing and the second group cream containing magnesium 2% and the third group combines althaea officinalis5% and magnesium 2% Cream 3 times a day after changing diaper topical use in place.
Category
Treatment - Drugs
2
Description
the control group used receive Calendula Cream 3 times a day after changing diaper topical use in place
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar hospital
Full name of responsible person
Abolfazl Khoshde
Street address
Hajar Hospital of Shahrekord University of Medical Sciences, Parastar street, Shahrekord
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Shahrekord University of Medical Scie
Full name of responsible person
Dr. Kamal Solati
Street address
Shahrekord University of Medical Sciences, Kashani street, Shahrekord
City
Shahrekord
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 Shahrekord University of Medical Scie
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
Shahrekord University of Medical Sciences
Full name of responsible person
Abolfazl Khoshdel
Position
Pediatrician, Associate Professor
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciences, Kashani street, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38 3222 0016
Fax
Email
keivaniz@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Abolfazl Khoshdel
Position
Pediatrician, Associate Professor
Other areas of specialty/work
Street address
Hajar Hospital of Shahrekord University of Medical Sciences, Parastar street, Shahrekord
City
Shahrekord
Postal code
Phone
00
Fax
Email
keivaniz@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Abolfazl Khoshdel
Position
Pediatrician, Associate Professor
Other areas of specialty/work
Street address
Hajar Hospital of Shahrekord University of Medical Sciences, Parastar street, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38 3222 0016
Fax
Email
keivaniz@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)