Comparison of the effect of Vaseline, honey, and honey-Vaseline combination versus control group on the severity of hand eczema: a randomized clinical trial
To compare the effect of Vaseline, honey, and honey-Vaseline combination versus control group on the severity of hand eczema
Design
This is a randomized clinical trial, phase II, in which 128 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients with eczema referring to the Besat Hospital in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the block randomization.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 65 years,
Hand eczema,
Exclusion criteria:
Pregnancy or breastfeeding,
Using corticosteroid or immunosuppressive drugs in the past month
Intervention groups
Intervention group 1:
Topical ointment including Vaseline every 12 hours for 4 weeks
Intervention group 2:
Topical ointment including honey every 12 hours for 4 weeks
Intervention group 3:
Topical ointment including honey-Vaseline combination every 12 hours for 4 weeks
Control:
Receive no ointment.
Main outcome variables
Primary outcome:
The severity of eczema
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N357
Registration date:2020-06-03, 1399/03/14
Registration timing:retrospective
Last update:2020-06-03, 1399/03/14
Update count:0
Registration date
2020-06-03, 1399/03/14
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-13, 1399/01/25
Expected recruitment end date
2020-05-14, 1399/02/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Vaseline, honey, and honey-Vaseline combination versus control group on the severity of hand eczema: a randomized clinical trial
Public title
Comparison of the effect of Vaseline, honey, and honey-Vaseline combination versus control group on the severity of hand eczema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 65 years,
Hand eczema,
Exclusion criteria:
Pregnancy or breastfeeding,
Using corticosteroid or immunosuppressive drugs in the past month
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
128
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare eight sheets of paper, writing on two sheets the name of the intervention 1 and on two sheets the name of the intervention 2 and on two sheets the name of intervention 3 and on two sheets the name of control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all eight sheets are drawn. The six paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2020-04-11, 1399/01/23
Ethics committee reference number
IR.UMSHA.REC.1399.053
Health conditions studied
1
Description of health condition studied
Eczema
ICD-10 code
B00.0
ICD-10 code description
Eczema herpeticum
Primary outcomes
1
Description
The severity of eczema
Timepoint
Before the intervention and 2 and 4 weeks after that
Method of measurement
Through the physical examination and using Hexy Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Topical ointment including Vaseline every 12 hours for 4 weeks
Category
Treatment - Drugs
2
Description
Intervention group 2: Topical ointment including honey every 12 hours for 4 weeks
Category
Treatment - Drugs
3
Description
Intervention group 3: Topical ointment including honey-Vaseline combination every 12 hours for 4 weeks
Category
Treatment - Drugs
4
Description
Control:Receive no ointment.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital in Hamadan city
Full name of responsible person
Mehran Mohammadi
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
mehranmohammadi20@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Mehran Mohammadi
Position
Student of Nursery
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
mehranmohammadi20@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Khodayar Oshvandi
Position
Nursing Education Specialist
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
oshvandi2005@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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