Protocol summary

Summary
The purpose of this study is checking of topical application of pumpkin ointment, products of traditional medicine on chronic hand eczema.The study is a double-blind clinical trial.Inclusion criteria: Interested in participating in the study; Age 18+; In patients with mild to moderate chronic hand eczema according to criteria HECSI. (Occupational dermatitis, atopic dermatitis, contact dermatitis irritant); Non-use of oral corticosteroids during the last two months;Lack of local immunosupresor within four weeks prior to treatment; Lack of pregnancy and lactation; No history of contact dermatitis to prescription drugs; Lack of local infection; Having no obsessive and excessive washing with water and detergent; Absence of immunosuppressive disease exclusion criteria: History of allergy to drugs; Use of oral or topical corticosteroids during the 4 weeks before the study; Local infection at the site of the lesion eczema; Women during pregnancy or lactation; Patients with severe obsessive washing; Having a physical or mental disorders that interfere with participation in the study Patients are over 18 years old with mild to moderate chronic hand eczema among patients referred to the dermatology clinic of Imam Khomeini hospital.The sample size is 60 Person. Patients were randomly divided into four groups receiving pumpkin cream, emollient and corticosteroid (betamethasone 1 /.%) and put almond cream.They shuld use up to one gram of topical ointment on the lesion twice a day for a period of four weeks (28 days). At the first visit, the day fourteenth and twenty-eighth day after the beginning of each meeting HECSI and DLQI (in Farsi with a standardized questionnaire) will be reviewed.In addition, each session using a camera with specific characteristics The wound will be photographed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014012916412N1
Registration date: 2015-06-17, 1394/03/27
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-06-17, 1394/03/27
Registrant information
Name
Alemeh Khademi
Name of organization / entity
School of Traditional Medicine، Tehran university of medical sciense
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 5295
Email address
a-khademi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-09-24, 1393/07/02
Expected recruitment end date
2016-09-24, 1395/07/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of topical pumpkin, traditional medicine products,on the chronic hand eczema
Public title
Effects of pumpkin (moschata cucurbita )ointment on chronic hand eczema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Interested in participating in the study; Age 18+; In patients with mild to moderate chronic hand eczema according to criteria HECSI. (Occupational dermatitis, atopic dermatitis, contact dermatitis irritant); Non-use of oral corticosteroids during the last two months; Lack of local immunosupresor within four weeks prior to treatment; Lack of pregnancy and lactation; No history of contact dermatitis to prescription drugs; Lack of local infection; Having no obsessive and excessive washing with water and detergent; Absence of immunosuppressive disease exclusion criteria: History of allergy to drugs; Use of oral or topical corticosteroids during the 4 weeks before the study; Local infection at the site of the lesion eczema; Women during pregnancy or lactation; Patients with severe obsessive washing; Having a physical or mental disorders that interfere with participation in the study
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, School of Traditional Medicine
City
Tehran
Postal code
Approval date
2015-04-08, 1394/01/19
Ethics committee reference number
tums.rec 9021309001-139191

Health conditions studied

1

Description of health condition studied
Chronic hand eczema
ICD-10 code
L30.9
ICD-10 code description
Other dermatitis

Primary outcomes

1

Description
Dermatology Life Quality Index
Timepoint
Before the intervention, 14 and 28
Method of measurement
Questionnaire

2

Description
Hand Eczema Severity Index
Timepoint
Before the intervention, 14 and 28
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Recovery rates
Timepoint
Before the intervention, the day Fourteenth and twenty-eighth
Method of measurement
Picture

2

Description
Skin reactions
Timepoint
Before the intervention, the day Fourteenth and twenty-eighth
Method of measurement
Questionnaire

Intervention groups

1

Description
Betamethasone ointment twice a day One Month
Category
Treatment - Drugs

2

Description
Almond ointment twice a day One Month
Category
Treatment - Drugs

3

Description
Eucerin ointment twice a day One Month
Category
Treatment - Drugs

4

Description
pumpkin ointment twice a day for one Month
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Alemeh khademi
Street address
Skin clinic,Imam Khomeini Hospital,Keshavarz bulv
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Tehran university School of Traditional Medicine
Full name of responsible person
Dr.Roja rahimi
Street address
Tehran University of Medical Sciences, Tehran university, Enghelab Square
City
Tehran
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 of Tehran university School of Traditional Medicine
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
Tehran University of Medical Sciences
Full name of responsible person
Alemeh khademi
Position
Postgraduate Iranian Traditional Medicine
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, Tehran university, Enghelab Square
City
Tehran
Postal code
Phone
00
Fax
Email
alemehkhademi@gmail.com; khademi_aa@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Parvin Mansouri
Position
Dermatologist and faculty of Tehran University
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, Tehran university, Enghelab Square
City
Tehran
Postal code
Phone
00
Fax
Email
mansouripr@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences, School of Traditional Medicine
Full name of responsible person
Alemeh Khademi
Position
Resident of traditional medicine
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, Tehran university, Enghelab Square
City
Tehran
Postal code
Phone
+98 21 8895 5295
Fax
Email
alemehkhademi@gmail.com; khademi_aa@yahoo.com
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
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