Our objective is to evaluate the effect of alcoholic extract of FP on hand eczema. This randomized double-blind, placebo-controlled study assesses efficacy of alcoholic extract of FP on hand eczema. 44 patients are randomly assigned to apply 4% cream of FP or vehicle cream to hand twice daily for 4 weeks. The primary outcome is reduction of hand eczema and the evaluation is done by EASI score.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138810303074N1
Registration date:2010-02-16, 1388/11/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-02-16, 1388/11/27
Registrant information
Name
Mehdi Pasalar
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1233 7589
Email address
pasalar@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2010-01-30, 1388/11/10
Expected recruitment end date
2010-03-01, 1388/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Fumaria parviflora. L extract on chronic hand eczema: a randomized double-blind, placebo-controlled study
Public title
The effects of Fumaria parviflora. L extract on chronic hand eczema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Healthy patients with hand eczema, not using topical medication in 2 weeks or systemic medication in one month prior to the study.
Exclusion criteria: pregnancy or breast feeding, hypersensitivity to test medication
Age
From 12 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences Ethics Committee
Street address
Zand Bld.
City
Shiraz
Postal code
Approval date
1384-12-28, 765/01/-446
Ethics committee reference number
CT-84-2759
Health conditions studied
1
Description of health condition studied
Hand eczema
ICD-10 code
L20.8
ICD-10 code description
Diseases of the skin and subcutaneous tissue
Primary outcomes
1
Description
reduction of Hand eczema
Timepoint
before and and two weeks after termination of therapy
Method of measurement
eczema area and severity index (EASI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 4% topical cream of FP alcoholic extarct for 4 weeks, twice daily 10 grams on hand surface skin - control: vehicle cream as for treatment group
Category
Treatment - Drugs
2
Description
Control group: Placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Research Center for Traditional Med. and History of Med.
Full name of responsible person
Mehdi Pasalar
Street address
School of Medicine
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences, Vice Chancellor for Research
Full name of responsible person
Dr.Dabagh Manesh
Street address
Zand St.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences, Vice Chancellor for Research
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 Sciences
Full name of responsible person
Dr.Mehdi Pasalar
Position
MD. / MPH
Other areas of specialty/work
Street address
School of Medicine
City
Shiraz
Postal code
Phone
+98 71 1233 7589
Fax
Email
pasalar@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Farideh Jowkar
Position
MD, Assisstant Professor
Other areas of specialty/work
Street address
School of Medicine - Zand St.
City
Shiraz
Postal code
Phone
+98 71 1230 0049
Fax
+98 71 1230 0049
Email
jowkarf@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Farideh Jowkar
Position
Dermatologist
Other areas of specialty/work
Street address
Zand Bld.
City
Shiraz
Postal code
Phone
+98 71 1230 0049
Fax
+98 71 1230 0049
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)