Cutaneous leishmaniasis (CL) caused by Leishmania major is common in Middle East countries. Most therapies are limited and there is no effective vaccine for leishmaniasis. It has been reported that wet-cupping (a Complimentary and Alternative Medicine technique) has been effective in treatment of drug resistant CL. This study aim is to determine the efficacy of wet-cupping in treatment of L. major infected BALB/C mice. We have designed a randomized clinical trial with 6 mice in each experimental and control group.This study will perform at medical laboratory in Kermanshah University of Medical Science. 12 male BALB/c mice, aged 8-10 weeks, will be used (six mice for each experimental and control group). Each mouse will be infected with L. major on left hind footpad. Mice in intervention group will undergo wet-cupping once a week, up to 6 weeks. Footpad thickness index will be measured for continues 7 weeks in both groups. Moreover, spleen and lymph node cell culture will be done at week 9 after inoculation. Levels of IFN- γ and IL-4 will be measured as the markers of TH1 and TH2, respectively.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201306021310N9
Registration date:2013-06-03, 1392/03/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-06-03, 1392/03/13
Registrant information
Name
Alireza Ahmadi
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3428 2670
Email address
info-jivr@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Science
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2013-06-22, 1392/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of wet-cupping in treatment of BALB/c-mice infected by Leishmania major. Pilot Randomized Clinical Trial
Public title
Effectiveness of wet-cupping on cutaneous leishmaniasis
Purpose
Treatment
Inclusion/Exclusion criteria
male BALB/c mice, aged 8-10 weeks
Age
From 8 years old to 10 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
12
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
Kermanshah University of Medical Sciences
Street address
Shahid Beheshti Blv
City
Kermanshah
Postal code
Approval date
2012-12-21, 1391/10/01
Ethics committee reference number
911045
Health conditions studied
1
Description of health condition studied
Cutaneous leishmaniasis
ICD-10 code
B55.1
ICD-10 code description
Cutaneous leishmaniasis
Primary outcomes
1
Description
Footpad thickness index
Timepoint
Weekly for continues 7 weeks
Method of measurement
Vernier caliper
2
Description
Spleen and lymph node cell culture
Timepoint
Week 9
Method of measurement
Spleen and lymph node cell culture
3
Description
Levels of IFN- γ and IL-4
Timepoint
Week 9
Method of measurement
IFN- γ and IL-4 levels in supernatant
Secondary outcomes
empty
Intervention groups
1
Description
Wet-cupping
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Medical laboratory in Kermanshah University of Medical Science
Full name of responsible person
Street address
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Nourizad
Street address
Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Hamid Alipoor, MD
Position
Generam Practitioner
Other areas of specialty/work
Street address
Imam Reza hospital
City
Kermanshah
Postal code
Phone
+98 83 1427 6326
Fax
Email
hamid.alpr@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Alireza Ahmadi, MD. PhD
Position
Anesthesiologist
Other areas of specialty/work
Street address
Imam Reza Hospital
City
Kermanshah
Postal code
Phone
+98 83 1724 0890
Fax
Email
ahmadiar1012@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Alireza Ahmadi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Imam Reza Hospital
City
Kermanshah
Postal code
Phone
+98 83 1724 0890
Fax
Email
ahmadiar1012@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)