Comparison of the effect of Chamomile and Calendula ointment on controlling the severity of diaper dermatitis in NICU.
Design
The clinical trial with two groups (intervention and control) with a sample size of 80 individuals, pragmatic, double-blind, randomized
Settings and conduct
This study was conducted to compare the effect of chamomile ointment and calendula ointment on controlling the severity of diaper dermatitis in NICU newborns in Hashamateyeh Hospital in Sabzevar city. The outcome evaluator and the participants will be unaware of how the grouping is organized. Patients were randomly assigned to the first intervention group (Chamomile ointment) and second intervention group (Calendula ointment). The response to treatment is evaluated a 5-point scale at the end of day 5 after intervention for both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Mild to moderate diaper dermatitis with score one and two (limited to perineal and hips).
Exclusion Criteria: Having a defective immune system, Get Immunosuppressive Drugs, Sepsis, Oral thrush (Candidiasis), eczema, congenital diseases, fungal dermatitis, Having urinary tract infection (UTI) and skin allergy.
Intervention groups
First intervention group: Patients in this group use Chamomile ointment, each containing 100 grams of an ointment containing 45 grams of chamomile essential oil, topically 3 times a day for 5 days.
Second intervention group: Patients in this group use Calendula ointment, each containing 100 grams of an ointment containing 35 mg of extract of the plant, topically 3 times a day for 5 days.
Main outcome variables
Determine the severity of diaper dermatitis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181006041252N10
Registration date:2019-02-02, 1397/11/13
Registration timing:prospective
Last update:2019-02-02, 1397/11/13
Update count:0
Registration date
2019-02-02, 1397/11/13
Registrant information
Name
Mohammad Sahebkar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4401 8337
Email address
sahebkarm@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-05, 1397/11/16
Expected recruitment end date
2019-04-05, 1398/01/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Chamomile and Calendula ointment on controlling the severity of diaper dermatitis in NICU (Neonatal, Intensive Care Unit).
Public title
Comparison of the effect of Chamomile and Calendula ointment on controlling the severity of diaper dermatitis in NICU.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Mild to moderate diaper dermatitis with score one and two (limited to perineal and hips).
Exclusion criteria:
Having a defective immune system
Get Immunosuppressive Drugs
Sepsis, oral thrush (Candidiasis), eczema and congenital diseases and fungal dermatitis
Having urinary tract infection (UTI) and skin allergy
Age
From 1 month old to 12 months old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was conducted based on a permutation block, Accordingly, 20 blocks were allocated to patients, in each block, 2 were from following groups, treatment group A and group B. Eventually, after completing the blocks, Group A and B were treated with Chamomile ointment and Calendula cream, respectively.
Blinding (investigator's opinion)
Double blinded
Blinding description
Each person will be assigned a study code A and B, which will only be known to the researcher of the type of groups. The outcome evaluator and the patients are unaware of the groups. It should be noted that chamomile ointment oil and Calendula cream have been similar in appearance, color, and packaging.
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
Street address
Sabzevar University of Medical Sciences, Tohid Blvd, Sabzevar city
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Approval date
2019-01-06, 1397/10/16
Ethics committee reference number
IR.MEDSAB.REC.1397.089
Health conditions studied
1
Description of health condition studied
Diaper dermatitis
ICD-10 code
L22
ICD-10 code description
Diaper dermatitis
Primary outcomes
1
Description
Determine the severity of diaper dermatitis
Timepoint
At the beginning of the study (before the intervention), 3 and 5 days after the intervention
Method of measurement
Determination of the severity of dermatitis based on 5-point scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in this group use chamomile ointment, each containing 100 grams of an ointment containing 45 grams of chamomile essential oil, topically 3 times a day for 5 days.
Category
Treatment - Drugs
2
Description
Intervention group: Patients in this group use Calendula ointment, each containing 100 grams of an ointment containing 35 mg of extract of the plant, topically 3 times a day for 5 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Heshmatiyeh hospital
Full name of responsible person
Mahbube Navidi
Street address
Heshamatiyeh Hospital, Asadabady Ave., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 1014
Email
mahbube.navidi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr. Fereshte Ghorat
Street address
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 8319
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
Dr. Hassan Salehipoor
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 8337
Email
Salehipoor45@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr. Hassan Salehipoor
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9671965751
Phone
+98 51 4401 8337
Email
Salehipoor45@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mahbube Navidi
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 8337
Email
mahbube.navidi@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
Not applicable
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
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available