The effect of topical use of chamomile oil on the improvement of mild to moderate atopic dermatitis in infants. Determining and comparing SCORAD criteria as a measure of severity of the disease and reducing the amount of redness and dryness and the degree of itching and restlessness in the studied groups.Comprehensive and effective treatment for reducing and improving symptoms associated with atopic dermatitis in infancy
Design
Samples were assigned to randomly assigned block randomized sequences in two intervention groups (chamomile oil) and control group (oceerin).
In a double blind randomized clinical trial 52 infants suffering from atopic dermatitis and eczema who referred to the clinic of Hashamateyeh Sabzevar Hospital. And have entry criteria and no exit criteria are included in the study by a pediatrician.
Settings and conduct
The site of the study is in the clinic of Hashamateyeh Sabzevar Hospital. On the first day of treatment, first, the areas affected by atopic dermatitis are washed with water and used on the wet skin of the mother-in-law.This is repeated twice a day and for 14 days for topical oil of Chamomile and Oceerin.In order to double the study, Oceerin was prepared in similar packages of the same shape and randomly assigned to each of the packages.
Participants/Inclusion and exclusion criteria
Conditions of entry: Infants with mild to moderate atopic dermatitis (based on SCORAD criteria and pediatrician diagnosis) and conditions of non-entry: There are skin lesions other than dermatitis
Intervention groups
Groups: chamomile oil topically twice a day for 14 days in the affected areas of atopic dermatitis in the control group with the same method oceerin is given.
Main outcome variables
Reducing the extent of skin involvement in the area of dermatitis; Reducing dryness and irritation and redness; Reducing itching and insomnia and restlessness of infants;
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180108038274N1
Registration date:2018-04-19, 1397/01/30
Registration timing:registered_while_recruiting
Last update:2018-04-19, 1397/01/30
Update count:0
Registration date
2018-04-19, 1397/01/30
Registrant information
Name
neda sirghani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3667 6639
Email address
nedasirghani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-20, 1396/12/29
Expected recruitment end date
2018-08-22, 1397/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of a oil Containing Chamomile in the Treatment of Mild to Moderate Atopic Dermatitis: A Randomized, Double-blind controlled Trial
Public title
Efficacy of a oil Containing Chamomile in the Treatment Atopic Dermatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infants with atopic dermatitis (based on SCORAD criteria and pediatrician diagnosis)
Good birth weight for age
Lack of underlying diseases and congenital disorders.
Inclination mother's cooperation With the plan
Exclusion criteria:
Major medical diseases (immunodeficiency, growth and development disorders, genetic disorders)
The presence of skin lesions other than eczema in the areas of topical application of the drug
Use of medications that affect eczema during maternal or infant use
Cancellation of the patient to continue the study
Age
To 1 year old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: The samples were randomly assigned sequences of quadrilateral blocks determined by the statistic consultant and the patients admitted to the clinic, respectively, in the two groups of intervention (local chamomile oil) and the control group (oserin). In A double-blind study that can distract the test result is hidden from both the patient and the researcher's point of view in clinical and therapeutic work. In most cases, double-blind testing is performed to achieve a higher scientific standard.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to double the study, oil was prepared in similar packages of the same shape and randomly assigned to each of the packages.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Sabzevar University of Medical Sciences and Health Services
Street address
University of Sabzevar, University of Tabriz, Sabzevar University of Medical Sciences and Health Services
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Approval date
2018-02-18, 1396/11/29
Ethics committee reference number
IR.MEDSAB.REC.1396.143
Health conditions studied
1
Description of health condition studied
Atopic dermatitis
ICD-10 code
L20.9
ICD-10 code description
Atopic dermatitis, unspecified
Primary outcomes
1
Description
The severity of the involvement of dermatitis
Timepoint
Before starting treatment and on days 6, 13, 27
Method of measurement
Questionnaire and with SCORAD criteria for atopic dermatitis
2
Description
The dryness, redness and irritation
Timepoint
Before starting treatment and on days 6, 13, 27
Method of measurement
Questionnaire
3
Description
pruritus rate
Timepoint
Before starting treatment and on days 6, 13, 27
Method of measurement
Questionnaire
4
Description
Insomnia and restlessness of infants
Timepoint
Before starting treatment and on days 6, 13, 27
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Quality of Life
Timepoint
Before starting treatment and days 6, 13 and 27
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group:Chamomile oil twice a day for 14 days
Category
Treatment - Drugs
2
Description
Control group:Oceerin twice a day for 14 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Heshmatieh Sabzevar specialized and specialized hospital
Full name of responsible person
Dr. Aqiyullah Kikhosrowi
Street address
Heshmatieh Sabzevar specialized and specialized hospital
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 1702
Email
dr.keykhosravi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr. Fereshteh Gharat
Street address
University of Blvd., Sabzevar University of Medical Sciences and Health Services, Department of Research and Technology
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4444 6070
Email
drghorat@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Neda Sirghani
Position
General Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Besid of the Sabzevar Route Police - Girl's Dormitory at Sabzevar University of Medical Sciences
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4426 4588
Email
nedasirghani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr. Aqiyullah Kikhosrowi
Position
Pediatric Kidney Disease Specialty
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Asrar Street, Hashamtay Specialty Hospital
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 1600
Email
dr.keykhosravi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Neda Sirghani
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Besid of the Sabzevar Route Police - Girl's Dormitory at Sabzevar University of Medical Sciences
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4426 4588
Email
nedasirghani@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available