Aim: The study of therapeutic effects of herbal myrtus cream on Chronic itching of the skin lesions caused by sulfur mustard on chemical warfare and comparison with current treatments.
Study feature: randomize, Double blind, control with Placebo.
Inclusion criteria consisted of Iranian veterans of the Iraq–Iran war who were suffering from chronic pruritic skin lesions. Exclusion criteria: patients were excluded if itching resulted from systemic or cutaneous non-chemical diseases. Target sample size included 60 subjects (30 control –30 patient ). Intervention: myrtus cream applied on skin twice a day for 2 weeks or 1 month . control group :base cream applied on skin twice a day for 2 weeks or 1 month. Primary outcomes included pruritus and atopic dermatitis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014090819090N1
Registration date:2014-11-21, 1393/08/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-11-21, 1393/08/30
Registrant information
Name
Maryam Iman
Name of organization / entity
Chemical Injuries Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 8248 2496
Email address
iman1359@yahoo.com
Recruitment status
Recruitment complete
Funding source
Chemical Injuries Research Center of Baqiyatallah University
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2015-06-22, 1394/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of myrtus communis cream on sulphur mustard-induced chronic pruritus compare to current treatments
Public title
Effect of myrtus cream on SM-induced skin pruritus
Purpose
Treatment
Inclusion/Exclusion criteria
Included subjects were Iranian veterans of the Iraq–Iran war who were suffering from chronic pruritic skin lesions.
Patients were excluded if itching resulted from systemic or cutaneous non-chemical diseases,or if they had received any topical treatments within 1
month before the study.
Age
No age limit
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 Baqiyatallah University of Medical Sciences
Street address
Nosrati alley, Sheikh Bahayi, Mollasadra
City
Tehran
Postal code
Approval date
2014-05-31, 1393/03/10
Ethics committee reference number
340/3/5291
Health conditions studied
1
Description of health condition studied
Atopic dermatitis
ICD-10 code
XII
ICD-10 code description
Diseases of the skin and subcutaneous tissue
2
Description of health condition studied
Pruritus
ICD-10 code
XII
ICD-10 code description
Diseases of the skin and subcutaneous tissue
Primary outcomes
1
Description
Pruritus
Timepoint
one month
Method of measurement
Visual Analogue Scale questionnaire and Examination
2
Description
atopic dermatitis
Timepoint
1 month
Method of measurement
Scoring of Atopic Dermatitis and Dermatology Life Quality Indexs and Examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: myrtus cream on skin twice a day for 2 weeks or 1 month
Category
Treatment - Drugs
2
Description
Control group: base cream on skin twice a day for 2 weeks or 1 month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah Hospital
Full name of responsible person
Maryam Iman
Street address
Baqiyatallah Hospital Molasadra street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Chancellor for Research of Baqiyatallah University of Medical
Full name of responsible person
Yunes Panahi
Street address
Mollasadra, Shekh Bahayi, Baqiyattallah university
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Chancellor for Research of Baqiyatallah University of Medical
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
Chemical Injuries Research Center
Full name of responsible person
Maryam Salehi
Position
Ph. D. Student
Other areas of specialty/work
Street address
Nosrati, Shekh Bahayi, Mollasadra,
City
Tehran
Postal code
Phone
+98 21 6653 6094
Fax
Email
maryam.salehi60@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Chemical Injuries Research Center
Full name of responsible person
Maryam Iman
Position
Pharmaceutics Ph. D.
Other areas of specialty/work
Street address
Mollasadra, Shekh Bahayi, Baqiyattallah university
City
Tehran
Postal code
Phone
+98 21 8248 2496
Fax
Email
iman1359@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Baqiyattallah University
Full name of responsible person
Maryam Salehi
Position
Ph. D. Student
Other areas of specialty/work
Street address
Nosrati, Sheikh bahayi, Mollasadra
City
Tehran
Postal code
Phone
+98 21 8248 2496
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)