The aim of this study was to compare the effectiveness of topical application of traditional medicine products "Henna", and %1 Hydrocortisone ointment on treatment level of diaper dermatitis in children under two years old. This study was a double blind randomized clinical trial. Eighty-eight infants under two years, referred to a hospital clinic with diaper dermatitis were selected and divided randomly into two groups. Then the mothers were instructed to put the ointment on the affected area three times daily after cleaning and washing there. The severity and extension of dermatitis areas was measured at first, third and the fifth day after intervention and the rate of recovery were compared in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014080318665N1
Registration date:2014-09-23, 1393/07/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-09-23, 1393/07/01
Registrant information
Name
Abdollah Keshavarz
Name of organization / entity
Research Institute for Islamic and Complementary Medicine ; Iran University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3366 4302
Email address
salamatparsi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Iran University Of Medical Sciences
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2013-11-21, 1392/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy of traditional medication of Henna and Hydrocortisone ointment 1% on diaper dermatitis healing among infants
Public title
Comparison the effect of traditional medication of Henna and Hydrocortisone ointment 1% on diaper dermatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The Infants under 24 months. Exclusion criteria: Existence of known diseases that need special treatment; The use of other drugs for healing diaper dermatitis; The use of antibiotics during research;
Existence diaper dermatitis due to fungal that diagnosed by Pediatrician
Age
From 1 month old to 2 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
88
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
Research Institute for Islamic and Complementary Medicine ; Iran University Of Medical Sciences
Street address
No. 9, Pirnia Alley, North Laleh-Zar Street, Tehran, Iran
City
Tehran
Postal code
-
Approval date
2012-12-16, 1391/09/26
Ethics committee reference number
11180/ت/م
Health conditions studied
1
Description of health condition studied
Diaper dermatitis
ICD-10 code
L22
ICD-10 code description
Diaper [napkin] dermatitis
Primary outcomes
1
Description
The severity of dermatitis
Timepoint
Baseline, days 3 and 5 of study
Method of measurement
Six-point scale for severity of diaper dermatitis
Secondary outcomes
1
Description
Dermatitis extent- Side effects
Timepoint
Baseline, days 3 and 5 of study
Method of measurement
Checklist
Intervention groups
1
Description
Group 1: To use traditional product of henna three times a day after diaper change.
Category
Treatment - Drugs
2
Description
Group 2: To use one percent hydrocortisone ointment twice daily for the affected area.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Qods Children's Medical Center
Full name of responsible person
Dr. Keshavarz
Street address
Qods Square, Shahid Beheshti Blvd, Qazvin, Iran
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University Of Medical Sciences
Full name of responsible person
Ashkan Divanbeighi
Street address
Hemmat Highway, Iran University of Medical Sciences, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Faculty of traditional medicine: Iran University Of Medical Sciences
Full name of responsible person
Abdollah- Keshavarz
Position
Ph.D student of traditional medicine
Other areas of specialty/work
Street address
No. 9, Pirnia Alley, North Laleh-Zar Street, Tehran, Iran
City
Tehran
Postal code
-
Phone
+98 28 3366 4302
Fax
-
Email
salamatparsi@yahoo.com
Web page address
-
Person responsible for scientific inquiries
Contact
Name of organization / entity
Research Institute for Islamic and Complementary Medicine ; Iran University Of Medical Sciences
Full name of responsible person
Abdollah-Keshavarz
Position
Ph.D student of traditional medicine
Other areas of specialty/work
Street address
No. 9, Pirnia Alley, North Laleh-Zar Street, Tehran, Iran
City
Tehran
Postal code
-
Phone
+98 28 3366 4302
Fax
+98 28 3366 2090
Email
salamatparsi@yahoo.com
Web page address
-
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Scienses
Full name of responsible person
Abdollah- Keshavarz
Position
Ph.D Student of traditional medicine
Other areas of specialty/work
Street address
No. 9, Pirnia Alley, North Laleh-Zar Street, Tehran, Iran
City
Tehran
Postal code
-
Phone
+98 28 3366 4302
Fax
-
Email
salamatparsi@yahoo.com
Web page address
-
Sharing plan
Deidentified Individual Participant Data Set (IPD)