The aim of this study is the evaluation of Boswellia serrata extract cream on patients with atopic Eczema
Design
This study was a double-blind, controlled trial, 33 patients with atopic eczema were assigned in each group. For randomization, the permuted block randomization will be used with quadruple blocks, In order to apply the concealment in the randomization process, unique codes, which is generated by the software, will be used on the drug boxes.
Settings and conduct
All patients referred to Imam Khomeini Hospital of Ahvaz, Iran, were assigned randomly in one of the placebo and treatment groups for 2 weeks
Participants/Inclusion and exclusion criteria
Inclusion criteria: Atopic ezema, not pregnancy, non lactation, not using oral and topical medication for treatment
Exclusion criteria: Occurrence of local infection, occurrence to other skin diseases, drug sensitivity
Intervention groups
Intervention group: 33 patients with atopic Eczema, each receive herbal cream 3 times a day for 2 weeks
Control group:33 patients with atopic Eczema, each receive placebo cream 3 times a day for 2 weeks
Main outcome variables
Edema
Dryness
Erythema
Pruritus
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111105008013N5
Registration date:2018-10-20, 1397/07/28
Registration timing:registered_while_recruiting
Last update:2018-10-20, 1397/07/28
Update count:0
Registration date
2018-10-20, 1397/07/28
Registrant information
Name
Amir Siahpoosh
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3334 2197
Email address
siahpoosh-a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
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
Double-blind placebo-controled clinical trial of Boswellia serrata extract in the treatment of atopic eczema
Public title
Effect of frankincense in treatment of eczema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Atopic ezema
Not pregnancy
Non lactation
Not using oral and topical medication for treatment
Exclusion criteria:
Occurrence of local infection
Occurrence to other skin diseases
Drug sensitivity
Age
From 18 years old to 55 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, the permuted block randomization will be used with quadruple blocks. blocks will be produced by using the online site (www.sealedenvelope.com).
Blinding (investigator's opinion)
Double blinded
Blinding description
Unique codes, which is generated by the software, will be used on the drug boxes. By entering each individual into the study based on the produced sequence, the drug box in which the code is registered, will be assigned to the individual. During the research, the randomization list is held by the statistic consultant, and the participants, the project implementer and all those who participate in the measurement of the indicators will not be aware of the assigned groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan Road
City
Ahvaz
Province
Khouzestan
Postal code
6135733184
Approval date
2018-03-06, 1396/12/15
Ethics committee reference number
IR.AJUMS.REC.1396.1076
Health conditions studied
1
Description of health condition studied
Atopic eczema
ICD-10 code
L20
ICD-10 code description
Atopic dermatitis
Primary outcomes
1
Description
Edema
Timepoint
Start intervention and two week later
Method of measurement
According to severity was scored 0 to 3
2
Description
Dryness
Timepoint
Start intervention and two week later
Method of measurement
According to severity was scored 0 to 3
3
Description
Erythema
Timepoint
Start intervention and two week later
Method of measurement
According to severity was scored 0 to 3
4
Description
Pruritus
Timepoint
Start intervention and two week later
Method of measurement
According to severity was scored 0 to 3
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Herbal cream 3 times a day for 2 weeks
Category
Treatment - Drugs
2
Description
Control group: placebo cream 3 times a day for 2 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Imam Khomeini Hospital
Full name of responsible person
Amir Siahpoosh
Street address
Bist-o Chahr Metri St
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 2114
Email
Amirsiahpoosh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences, medicinal plants research center
Full name of responsible person
Dr Mohamad badavi
Street address
Ahvaz golestan road
City
ahvaz
Province
Khouzestan
Postal code
6135733184
Phone
+98 61 3336 2414
Email
amirsiahpoosh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur University of Medical Sciences, medicinal plants research center
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
Ahvaz University of Medical Sciences
Full name of responsible person
Amir Siahpoosh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Golestan road
City
Ahvaz
Province
Khouzestan
Postal code
6135733184
Phone
+98 61 3334 2197
Fax
Email
siahpoosh-a@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Amir Siahpoosh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Golestan road
City
Ahvaz
Province
Khouzestan
Postal code
6135733184
Phone
+98 61 3334 2197
Fax
Email
siahpoosh-a@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Amir Siahpoosh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Golestan road
City
Ahvaz
Province
Khouzestan
Postal code
6135733184
Phone
+98 61 3334 2197
Fax
Email
siahpoosh-a@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only a part of the data will be shared
When the data will become available and for how long
The access period will be 6 months after the publication of the results
To whom data/document is available
The obtained data from current study will be available only for researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Six months after the publication of this study papers, the obtained data will be available to the applicant researchers for further analysis
From where data/document is obtainable
Applicants can be contacted with corresponding author by e-mail
What processes are involved for a request to access data/document
Applicants will be able to access the obtained data from current study by sending an email to the corresponding author up to one month