Determine the effect of (Salvia officinalis L.) ointment and common treatment on intensity, extent, pain and duration of diaper-induced dermatitis.
Design
This study will be a clinical trial with a control group, with parallel groups, double-blind, randomized allocation and phase 2 on 60 infants. In phase 1, the ointment is tested on 6 to 8 infants, which is performed in the next phase if it has beneficial therapeutic effects.
Settings and conduct
Samples are selected from children under 2 years of age admitted to different wards of children in Imam Sajjad Hospital in Yasuj, who, according to the clinical diagnosis of a pediatrician, have degrees of diaper dermatitis using non probability convenience sampling method. After obtaining the informed consent of each patient, they are randomly assigned to one of the two intervention and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1- Children under two years old.2- Use disposable diapers or disposable pads.3. Do not have known immune system weakness.4- Do not receive drugs that weaken the immune system.5 - Lack of special food and drug allergies.6. Do not have special skin allergies.7- Do not suffer from extensive skin infections.8- Parents should be willing to participate in the study.Exclusion criteria: 1.Discontinue treatment or change it for any reason during the treatment period. 2- In case of occurrence and identification of a new problem affecting the child's rash. 3-People who take care of a new drug and especially a plant to treat dermatitis.
Intervention groups
The intervention group includes children with diaper dermatitis who receive (Salvia officinalis L.) ointment intervention.
The control group includes children with diaper dermatitis who receive routine treatment intervention.
Main outcome variables
Intensity, extent, pain and duration of dermatitis recovery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190120042436N3
Registration date:2020-11-10, 1399/08/20
Registration timing:prospective
Last update:2020-11-10, 1399/08/20
Update count:0
Registration date
2020-11-10, 1399/08/20
Registrant information
Name
Mohsen Salari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3323 4115
Email address
salarimo@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2020-11-21, 1399/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of (Salvia officinalis L.) ointment and common treatment on diaper-induced dermatitis in children
Public title
Effect of (Salvia officinalis L.) ointment on diaper-induced dermatitis in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Children under two years of age 2 - use disposable diapers or disposable pad. 3. Lack of recognized immune system weakness. (based on the physician diagnosis.)4. do not use certain drugs to suppress immune system5- Lack of specific food and drug allergies 6 - Lack of specific skin sensitivity. 7. Lack of extensive skin infections 8 - Parents tend to participate in the study.
Exclusion criteria:
1. Discontinue treatment or change treatment for any reason during the treatment period. 2- In case of occurrence and identification of a new problem affecting the child's rash. 3-People who take care of a new drug and especially a plant to treat dermatitis.
Age
From 1 day old to 2 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Based on a simple random method, each person who meets the inclusion criteria is assigned to one of the two groups of intervention or routine treatment by lot.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the participants do not know that they are in which of the groups under study, while the ward nurse as a clinical caregiver and the doctor as an outcome assessor does not know the type of interventions performed for patients. The data analyzer also does not know the allocation of study groups because it will be specified as A and B.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
Shahid Jalil Street. Educational Pardis, Yasuj.
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
94799 – 75919
Approval date
2020-07-08, 1399/04/18
Ethics committee reference number
IR.YUMS.REC.1399.106
Health conditions studied
1
Description of health condition studied
Diapper Rash
ICD-10 code
L22
ICD-10 code description
Diaper dermatitis
Primary outcomes
1
Description
Percentage of people whose severity and extent of dermatitis is equal to or greater than average based on checklists.
Timepoint
The beginning of the study, the second, fourth and sixth day after starting treatment
Method of measurement
A five-point scale is used to measure the severity and extent of diaper rash, and a Modified Behavioral Pain Scale is used for pain.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Treated with Salvia officinalis L.ointment which contains 28% hydroalcoholic extract of the aerial part of the plant contains leaves, flowers and stems and similar to Salvizan gel. After washing and drying the dermatitis area, depending on the extent of dermatitis, this ointment will be used 3 times a day for a maximum of 7 days to cover the surface of the dermatitis skin (1 Centimeter).
Category
Treatment - Drugs
2
Description
Control group: Treated with routine treatment (Zinc oxide and Hydrocortisone Ointments). Depending on the extent of dermatitis, these ointments will be used 3 times a day for a maximum of 7 days to cover the surface of the skin (1 Centimeter).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Sajjad Hospital
Full name of responsible person
Dr. Nikbakht; Dr. Abdolkarim Ghadimimoghadam
Street address
Kohkiluyeh and Boyer Ahmad, Yasuj, next to Azadi Hotel
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75919-94799
Phone
+98 74 3222 0163
Fax
+98 74 3323 4115
Email
salarimo@yums.ac.ir
Web page address
http://emamsajad.yums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Dr. Hossein Mari Oryad
Street address
Shahid Motahari Blvd., Vice Chancellor of Research, Yasuj University of Medical Sciences, Yasuj