The purpose of this study is the comparition of standard treatment of cutaneous leishmaniasis (cryotherapy) to a traditional herbal remedy. Eighty eight patients (2 groups of 44 patients) with positive direct smear of cutaneous leishmaniasis, number of scars less than 3 and disease period less than 3 months will entered in to the study. Wounds size will monitored weekly for one month in the 2 mentioned groups: 1 st group treated with daily 10 grams of herbal medicine while, 2 nd group would treat with 10-20 sec cryotherapy weekly for one month period of time.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013011512143N1
Registration date:2013-02-07, 1391/11/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-02-07, 1391/11/19
Registrant information
Name
Abdolali Mohagheghzadeh
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1242 4256
Email address
mohaghegh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Health system of Shiraz University of Medical Sciences
Expected recruitment start date
2013-01-29, 1391/11/10
Expected recruitment end date
2013-11-21, 1392/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of standard treatment of cutaneous leishmaniasis (cryotherapy) in comparison to a traditional herbal remedy
Public title
herbal medicine in cutaneous leishmaniasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: number of wound less than 3; disease period less than 3 months; without previous treatment; without systemic or other skin disease
Exclusion criteria: hypersensitivity to herbal medicine; pregnancy and etc
Age
No age limit
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Zand Blvd, Shiraz
City
Shiraz
Postal code
Approval date
2013-01-07, 1391/10/18
Ethics committee reference number
CT-91-6414
Health conditions studied
1
Description of health condition studied
Leishmaniasis
ICD-10 code
B55.1
ICD-10 code description
Cutaneous leishmaniasis
Primary outcomes
1
Description
complete treatment of Wound
Timepoint
before treatment, 1,2,3,4 weeks after treatment
Method of measurement
measurement of Wound size
Secondary outcomes
1
Description
adverse effect
Timepoint
before treatment, 1,2,3,4 weeks after treatment
Method of measurement
question from patient
Intervention groups
1
Description
treatment with daily 10 grams of herbal medicine for one month.
Category
Treatment - Drugs
2
Description
treatment with 10-20 Seconds cryotherapy for one month.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Health system of Shiraz University of Medical Sciences
Full name of responsible person
Alireza Barzegar
Street address
Zand Blvd. Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Shiraz University of Medical Sciences
Street address
Zand Blvd. Shiraz
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
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
Gholamreza Hatam
Position
Professor
Other areas of specialty/work
Street address
Zand Blvd. Shiraz
City
Shiraz
Postal code
Phone
+98 71 1235 7282
Fax
Email
hatamghr@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
Abdolali Mohagheghzadeh
Position
Professor
Other areas of specialty/work
Street address
Traditional pharmacy department, Shiraz School of Pharmacy
City
Shiraz
Postal code
Phone
+98 71 1242 4126
Fax
Email
mohaghegh@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Alireza Barzegar
Position
student
Other areas of specialty/work
Street address
Shiraz School of Pharmacy
City
Shiraz
Postal code
Phone
00
Fax
Email
barzegarar@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)