Efficacy of topical products of sambucus ebulus in clinical severity
of patients with hand eczema
Design
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
This research، will be done on patients،aged18to60 years old، with hand eczema. This study will be done at Yahya Nejad hospital inBabol، andBaran(skin specialized clinic)in Arak.The patients are randomly assigned to either of the following groups:1. group that recieves the topical product of sambucus ebulus
2. group that recieves one percent Hydrocortisone cream.
The patients will be treated for six weeks. Patients are visited4 time points:1. at first attending session 2. at 14th day 3. at 28 th day 4. at 42th day. In each visit، theDermatology Life Quality Index(DLQI) questionnaire and the Hand Eczema Severity Index will be completed for them. Each time photos will be captured of skin damages.
After the forth weeks، we will give them 20 jujubes،every day for two weeks.They should boil them in the 4 glasses of water and after boiling ، 3 glasses of water will be remained.They will drink every 8 hours ، one glass of this water and also in this two weeks they should continue use of the topical drug prescribed in this study on their group.
Participants/Inclusion and exclusion criteria
Entry requirements: 1, aged 18 to 60 years;
Conditions of non-arrival: 1, pregnant mothers
Intervention groups
The topical product from the leaf ofsambucus ebulus has been developed as an intervention group and one percent Hydrocortisone cream as a control group.
Main outcome variables
The clinical severity of hand eczema;DLQI;Rate of healing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170930036486N2
Registration date:2018-05-17, 1397/02/27
Registration timing:prospective
Last update:2018-05-17, 1397/02/27
Update count:0
Registration date
2018-05-17, 1397/02/27
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 4730
Email address
a.moradi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-11-22, 1397/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between the efficacy of topical product of Sambucus ebulus and Hydrocortisone on the clinical severity of patients with hand eczema
Public title
Investigating the effect of Sambucus ebulus on hand eczema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 60 years
Patients with hands eczema who have not received any topical medication from the 14 days prior to study
Exclusion criteria:
Pregnant mothers
Nursing mothers
The presence of underlying diseases of the kidney, liver, heart, diabetes,
History of drug allergy
Patients with obsessive-compulsive disorder or other mental illness that interferes with the study
Use of Systemic Corticosteroids or Immunosupressives over the past 4 weeks
Localized infection in the place of eczema
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization: At first, blocks containing 4 of two treatments (Sambucus ebulus or Hydrocortisone) are written with different possible combinations, each given a number, and then using the random number table, each of the 4 blocks, one Of these compounds is devoted.
Blinding (investigator's opinion)
Double blinded
Blinding description
The form of the drug in the same tubes is provided by the pharmacologist. The smell of drugs is largely similar. The researcher does not know the content of the tubes and only the biostatistician knows about it. Patients are also unaware of the contents of the tubes.The conscientious consent will be given to patients and will be explained to them that there are two groups in this study : case and control and they will be in one of these groups by randomization.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee ofBabol University of Medical Sciences
Street address
Gang Afrooz street
City
Babol
Province
Mazandaran
Postal code
47176-47745
Approval date
2017-11-18, 1396/08/27
Ethics committee reference number
MUBABOL.HRI.REC.1396.112
Health conditions studied
1
Description of health condition studied
Hand eczema
ICD-10 code
L20-L30
ICD-10 code description
Dermatitis and eczema
Primary outcomes
1
Description
severity of hand eczema
Timepoint
Before the intervention begins، 14، 28، 42th day after starting of treatment
Method of measurement
Hand eczema severity index
2
Description
Dermatology Life Quality Index
Timepoint
Before the intervention begins، 14، 28، 42th day after starting of treatment
Method of measurement
Dermatology Life Quality Index questionnaire
Secondary outcomes
1
Description
Rate of healing
Timepoint
Before the intervention begins، 14، 28، 42th day after starting of treatment
Method of measurement
Hand eczema severity index
Intervention groups
1
Description
Intervention group:Topical product of sambucus ebulus،one gram،twice a day،six weeks.After the forth weeks، we will give them 20 jujubes،every day for two weeks.They should boil them in the 4 glasses of water and after boiling ، 3 glasses of water will be remained.They will drink every 8 hours ، one glass of this water.
Category
Treatment - Drugs
2
Description
Control group:Hydrocortisone cream،one gram،twice a day،six weeks.After the forth weeks، we will give them 20 jujubes،every day for two weeks.They should boil them in the 4 glasses of water and after boiling ، 3 glasses of water will be remained.They will drink every 8 hours ، one glass of this water.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yahya Nejad hospital and Baran clinic
Full name of responsible person
Akram moradi farahani
Street address
Farhang intersection in Babol andShahid shiroodi street in Arak
City
Babol and Arak
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 4730
Fax
+98 11 3219 4728
Email
a.moradi@mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
Gang Afrooz street
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 4730
Email
seyyedali1357@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Akram moradi farahani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Gang Afrooz street
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 4730
Fax
+98 11 3219 4728
Email
a.moradi@mubabol.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Seyyed Ali Mozaffarpur
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Gang Afrooz street
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 4730
Email
seyyedali1357@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Akram Moradi Farahani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Gang Afrooz street
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 4730
Fax
+98 11 3219 4728
Email
a.moradi@mubabol.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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is 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
Title and more details about the data/document
To publish the article,it will be available to the journal
When the data will become available and for how long
available after publishing the manuscript
To whom data/document is available
depend on the results, it will be decided
Under which criteria data/document could be used
depend on the results, it will be decided
From where data/document is obtainable
seyyedali1357@gmail.com
What processes are involved for a request to access data/document
After the permission of the Babil University of Medical Sciences, there is the possibility of transferring the documentation