1
Clinical Trial Protocol
Iranian Registry of Clinical Trials
05 Nov 2022
Comparison of the effect of aloe vera gel and Zinc oxide ointment on the improvement of disease caused by diapers.
Protocol summary
Summary
Objective: Comparison of the effect of aloe vera gel and zinc oxide ointment in treatment of diaper dermatitis in children 6-18 months referred to health centers Firozabad city. 2016 - 2017. Methods: This study is a controlled clinical trial. In this study, randomization was not done. This study is single blind . .The study on 40 children 6-18 months referred to health centers is done Firozabad city . Those who have inclusion criteria, and parents have the desire to participate in the study as one among the two groups are aloe vera gel and zinc oxide ointment and for three days the recommended medication use. After three days, come to the clinic.
Infectious and allergic or other problems in children will be discussed. If there is not a new problem, patients will continue to use zinc oxide and aloe vera gel.Then on the seventh day, the severity of dermatitis, assisted by the investigator (physician), who is unaware of the type of treatment, the five-point scale visual diaper dermatitis will be recorded. The condition of inclusion: the tendency of parents to participate in the study, the severity of diaper dermatitis Grade 1 and 2. The exclusion criteria were: lack of desire to continue the cooperation of parents in the study.The main outcome variables:
changes in diaper dermatitis recovery.
General information
Acronym
IRCT registration information
IRCT registration number: IRCT2016081029288N1 Registration date: 2016-09-03, 1395/06/13 Registration timing: registered_while_recruiting
Last update:
Update count: 0 Registration date
2016-09-03, 1395/06/13
Registrant information Name
Fatemeh Bayat Shahparast Name of organization / entity
Shiraz University of Medical Sciences.
Country
Iran (Islamic Republic of) Phone
+98 71 3647 4251 Email address
[email protected] Recruitment status
Recruitment complete Funding source
Vice Chancellor for Research , Shiraz University of Medical Sciences
Expected recruitment start date 2016-08-19, 1395/05/29
Expected recruitment end date 2016-09-15, 1395/06/25 Actual recruitment start date
empty
Actual recruitment end date empty
Trial completion date empty
Scientific title
Comparison of the effect of aloe vera gel and Zinc oxide ointment on the improvement of disease caused by diapers.
Public title
The effect of aloe vera gel on diaper dermatitis Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: having mild to moderate diaper dermatitis with score 1 and 2 (lesions confined to the perineum, buttocks)؛Not having a weakened immune
2 system and drug and food allergies, according to the
history obtained from the mother; no risk of sepsis, oral thrush, eczema, diabetes and congenital diseases;
Children's use of breast milk ; Do not use other drugs at the same time or before the intervention , the desired position. Exclusion criteria: Use of other drugs for the treatment of dermatitis during the study period; failure to complete the course of treatment for a urinary tract infection or other skin diseases during the study; skin allergy; unwillingness to continue to participate in the study; the occurrence of any disease or new problem or become fungal dermatitis.
Age
From 5 months old to 1 year old Gender
Both Phase
2-3
Groups that have been masked No information
Sample size
Target sample size: 40
Randomization (investigator's opinion) Not randomized
Randomization description Blinding (investigator's opinion)
Single blinded Blinding description Placebo
Not used Assignment
Parallel
Other design features
The study was not randomized, but as a people are among the groups.
Secondary Ids empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Ethics Committee, seventh floor, Shiraz University of Medical Sciences, next to the Red Crescent
headquarters, Zand Ave., Shiraz.
City Shiraz Postal code
71348-14336 Approval date
2016-08-07, 1395/05/17
Ethics committee reference number ir.sums.rec.1395.88
Health conditions studied
1
Description of health condition studied Rash- diaper
ICD-10 code l22
ICD-10 code description Rash - diper
Primary outcomes
1
Description Diaper dermatitis Timepoint
Before the intervention, the third day and the seventh day after intervention
Method of measurement
List of diaper dermatitis five visual point
Secondary outcomes empty
Intervention groups
1
Description
1- intervention: In the intervention group patients by the researcher some gel with aloe vera gel (1 x 1 cm) to arm children will be struck and twenty minutes later will be dealt with in the absence of aloe vera gel to the skin allergy researchers put mothers. During a half-hour meeting some tips on how to use aloe vera gel given to them will be trained and will be asked of them after washing the area with warm water and dry with a soft cloth without damaging the area , a layer of aloe vera gel to the area is once every 8 hours for a week dermatitis use. On the third day after the start of treatment to revisit dermatitis, children's clinic that if no new
problems or lack of exacerbating dermatitis or becoming fungal dermatitis the gel will to use of continue for a week. After a week of mothers are asked to bring the child to the clinic for the study blinding, the area treated by the doctor, that type of treatment used, is unaware of the list, the situation will be recorded dermatitis.
Category
Treatment - Drugs
2
Description
intervention 2: in the group treated with zinc oxide ointment mothers will be asked routine zinc oxide used as directed and on the third day to check dermatitis clinic and if any problem on the third day will be withdrawn from the study. Then at the end of the seventh day visit to the clinic for final review and process
3 improvement of disease will be evaluated in accordance
with the said list.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center Rural Health Database Jaydasht Full name of responsible person
Parvane Khalifa Street address
Rural health base , the main road , the village Jaydasht , Firozabad .
City
Firozabad
2
Recruitment center
Name of recruitment center
Comprehensive Database Urban Health , Issue 2 . Full name of responsible person
Hagar roosta Street address
Comprehensive health database , Street Dashti , Firozabad .
City
Firozabad
Sponsors / Funding sources
1 Sponsor
Name of organization / entity
Vice Chancellor for Research , Shiraz University of Medical Sciences
Full name of responsible person Doctor Sayed Basir Hashemi Street address
Vice chancellor for research, seventh floor, Shiraz University of Medical Sciences, next to the Red Crescent headquarters, Zand Ave., Shiraz City
Shiraz 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 , Shiraz 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
Shiraz University of Medical Science, Shiraz Hazrate Fatemeh Nursing and Midwifery college
Full name of responsible person Sedigh Montaseri
Position
Master's degree in nursing . the coach. Staff Shiraz University of Medical Sciences
Other areas of specialty/work Street address
Hazrate Fatemeh Nursing and Midwifery college, Namazi Square, Shiraz.
City Shiraz Postal code
13119–71936 Phone
+7 136474251 Fax
+98 36474252 Email
[email protected] Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Science, Shiraz Hazrate Fatemeh Nursing and Midwifery college
Full name of responsible person Sedigh Montaseri
Position
Master's degree in nursing . the coach. Shiraz faculty member Ddanshgah
Other areas of specialty/work Street address
Hazrate Fatemeh Nursing and Midwifery college, Namazi Square, Shiraz.
City Shiraz Postal code
71936 -13119 Phone
+98 71 3647 4251 Fax
+98 36474252 Email
[email protected] Web page address
4
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Science,Shiraz Hazrate Fatemeh Nursing and Midwifery college
Full name of responsible person Fateme Bayat Shahparst Position
Nursing Graduate Student Other areas of specialty/work Street address
Hazrate Fatemeh Nursing and Midwifery college, Namazi Square, Shiraz.
City Shiraz Postal code
71936 -13119 Phone
+98 71 3647 4251 Fax
+98 36474252 Email
[email protected] Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD) empty
Study Protocol empty
Statistical Analysis Plan empty
Informed Consent Form empty
Clinical Study Report empty
Analytic Code empty Data Dictionary
empty
