Evaluating efficiency of a topical medication based on garlic extract (Leish G1 cream) on cutaneous leishmaniasis
Design
A clinical trial, phase 3, 2 groups of control and intervention, each group has 50 patients
Settings and conduct
Patients who refer to health centers and specialized clinics in several cities in the south and west of the country are examined to approve leishmaniasis diagnose. After signing consent form, patients are assigned to either control or intervention group. Follow up and examination is done to determine the correct use of the drug and possible side effects and complete the questionnaire on days 1, 14, 28 and 60. On the 60th day, a test is performed again to evaluate wound healing.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients with Cutaneous leishmaniasis approved by direct examinations
Up to 5 lesions in each patient
Duration of disease up to 3 months
Patients who have not used anti leishmania therapies
Exclusion criteria:
Patients with Facial lesions
Patients with Lymphangitis lesions
Patients with Immunodeficiency disorders
Patients who use immunosuppressive drugs
Patients with other skin diseases
Patients with severe mental disorders
Concomitant use of other medication
Pregnancy or lactation
Intervention groups
Intervention group: Topical use of Leish G1 cream on leishmanial lesions twice daily for two months. The medication is a formulation of aquas garlic extract Control group: Meglumine Antimonate intralesional injection once weekly
Main outcome variables
Wound healing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180115038383N1
Registration date:2018-02-08, 1396/11/19
Registration timing:registered_while_recruiting
Last update:2018-02-08, 1396/11/19
Update count:0
Registration date
2018-02-08, 1396/11/19
Registrant information
Name
Tooba Ghazanfari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6642 6890
Email address
ghazanfari@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-04, 1396/11/15
Expected recruitment end date
2019-02-19, 1397/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation Leish G1 cream efficacy on healing the cutaneous leishmaniasis
Public title
Effect of Leish G1 cream in leishmaniasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Cutaneous leishmaniasis approved by direct examinations
Up to 5 lesions in each patient
Duration of disease up to 3 months
Patients who have not used anti leishmaniasis therapies
Exclusion criteria:
Patients with facial lesions
Patients with Lymphangitis lesions
Patients with Immunodeficiency disorders
Patients who use immunosuppressive drugs
Patients with other skin diseases such as Eczema, Psoriasis and Lupus
Patients with severe mental disorders such as Major Depressive Disorder and Psychosis
Concomitant use of other medications
Pregnancy or lactation
Age
From 12 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Not 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
Ethics committee of ُShahed University of Medical Sciences
Street address
Khalij Fars Freeway, across Imam khomeini shrine
City
Tehran
Province
Tehran
Postal code
3319118651
Approval date
2018-01-08, 1396/10/18
Ethics committee reference number
IR.Shahed.REC.1396.77
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
Wound healing
Timepoint
Evaluating size and grade of cutaneous lesion in days 0, 14, 28 and 60 aftertreatment
Method of measurement
Ruler
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Topical use of Leish G1 cream on leishmanial lesions twice daily for two months. The medication is a formulation of aquas garlic extract based on Eucerin, formulated in Behpad Teb Iranian laboratory and produced in Dineh Iran Industries complex.
Category
Treatment - Drugs
2
Description
Control group: Meglumine Antimonate intralesional injection once weekly
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mehri Ghafourian
Street address
Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3336 7543
Fax
+98 61 3333 2036
Email
ghafourian-m@ajms.ac.ir
2
Recruitment center
Name of recruitment center
Dezfool University of Medical sciences
Full name of responsible person
Abdolkarim Sheikhi
Street address
Research center, Dezfofl university of medical sciences, Azadegan Blvd, Azadegan
City
Dezfool
Province
Khouzestan
Postal code
6461643993
Phone
+98 61 4242 9733
Email
sheikhi@queensu.ca
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Tooba Ghazanfari
Street address
Khalij Fars Freeway, across Imam khomeini shrine
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 6641 8216
Email
ghazanfari@shahed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
Proportion provided by this source
40
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
2
Sponsor
Name of organization / entity
Behpad Teb Iranian
Full name of responsible person
Soosan Kaboodanian Ardestani
Street address
No 37, West Nosrat, North Kargar, Enghelab Squar
City
Tehran
Province
Tehran
Postal code
1418863981
Phone
+98 21 6642 6890
Email
ardestany@ut.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Behpad Teb Iranian
Proportion provided by this source
60
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Fateme Emadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmacognosy
Street address
No 1471, North Kargar Street, Enghelab Squar
City
Teharn
Province
Tehran
Postal code
1417953842
Phone
+98 21 6646 4320
Email
f.emadi@shahed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Fateme Emadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmacognosy
Street address
No 1471, North Kargar Street, Enghelab Squar
City
Teharn
Province
Tehran
Postal code
1417953842
Phone
+98 21 6646 4320
Email
f.emadi@shahed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Fateme Emadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmacognosy
Street address
No 1471, North Kargar Street, Enghelab Squar
City
Teharn
Province
Tehran
Postal code
1417953842
Phone
+98 21 6646 4320
Email
f.emadi@shahed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
After publishing the final results, the study protocol, statistical analyzes and consent form will be shared without mentioning the names of the individuals.
When the data will become available and for how long
6 months after publishing results
To whom data/document is available
Iranian researchers
Under which criteria data/document could be used
To design review articles, statistical analysis and bioinformatics studies
From where data/document is obtainable
Study executor with permission of Shahed university research center
What processes are involved for a request to access data/document
Written request to the Study executor
Refer to the Research Center at Shahed University
Getting research center approval
access to data