A clinical study of the effıcacy of oral allopurinol and itraconazole in comparison with parenteral meglumine antimoniate in the treatment of old-world cutaneous leishmaniasis in Mashhad
Determination of treatment effect of combination of oral allopurinol and itraconazole in comparison with parenteral MA in treatment of cutaneous leishmaniasis
Design
eligible people based on their personal choice enter one the the two groups of study and each group has 15 people and there is no need for randomization because our study is descriptive
Settings and conduct
diseases with leishmaniasis refer to dermatology clinic of Imam Reza Hospital, Mashhad
Participants/Inclusion and exclusion criteria
The disease should be diagnosed by direct smear
Duration from time of diagnosis up to now is less than 6 months
Not receiving any systemic treatment for leishmaniasis previously
Not having immunosuppressive condition or contraindication for drugs
Intervention groups
IM Glucantim 20 mg/kg/day for 20 days in one group
and Allopurinol 10 mg/kg/day and Itraconazole 4 mg/kg/day (both of them are oral) for the other group
Main outcome variables
size of lesion
Result of treatment (cure, recurrency, failure)
Tolerance of medication
Side effects of treatment
Compliance on treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250825066995N1
Registration date:2025-10-07, 1404/07/15
Registration timing:registered_while_recruiting
Last update:2025-10-07, 1404/07/15
Update count:0
Registration date
2025-10-07, 1404/07/15
Registrant information
Name
Sorour Attaran
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3879 9414
Email address
sorourattarang@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-09-30, 1404/07/08
Expected recruitment end date
2027-03-21, 1406/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical study of the effıcacy of oral allopurinol and itraconazole in comparison with parenteral meglumine antimoniate in the treatment of old-world cutaneous leishmaniasis in Mashhad
Public title
Comparison of allopurinol and itraconazole with glucantim in treatment of leishmaniasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The disease should be diagnosed by direct smear
Duration from time of diagnosis up to now is less than 6 months
Not receiving any systemic treatment for leishmaniasis previously
Not having immunosuppressive condition or contraindication for drugs
Exclusion criteria:
Age
From 12 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
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 Mashhad University of Medical Sciences
Street address
Dermatology clinic of Imam Reza Hospital, against Kafaei street, Daneshgah Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Approval date
2025-07-09, 1404/04/18
Ethics committee reference number
4022671
Health conditions studied
1
Description of health condition studied
Cutaneous leishmaniasis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Size of lesion
Timepoint
45 and 90 days after treatment
Method of measurement
Ruler
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Allopurinol 10 mg/kg/day and Itraconazole 4 mg/kg/day (both of them are oral)
Category
Treatment - Drugs
2
Description
Intervention group: IM Glucantim 20 mg/kg/day for 20 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology clinic of Imam Reza hospital
Full name of responsible person
Sorour Attaran
Street address
Dermatology clinic of Imam Reza Hospital, against Kafaei street, Daneshgah Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
sorourattarang@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Mashhad University of Medical science Goreyshi Building, Daneshgah Ave. Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
913753459
Phone
+98 51 3841 1538
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
99
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
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sorour Attaran
Position
Dermatology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Dermatology clinic of Imam Reza Hospital, against Kafaei street, Daneshgah Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
sorourattarang@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Vahid Mashayekhi Goyonlo
Position
professor
Latest degree
Specialist
Other areas of specialty/work
dermatology
Street address
Imam Reza Hospital, Imam Reza Square, Ebne Sina Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2020
Email
mashayekhiv@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Vahid Mashayekhi Goyonlo
Position
professor
Latest degree
Specialist
Other areas of specialty/work
dermatology
Street address
Imam Reza Hospital, Imam Reza Square, Ebne Sina Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2020
Email
mashayekhiv@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
all of data are sharable after making them anonymous
When the data will become available and for how long
6 months after publishing results
To whom data/document is available
data are available for scientific and academic researchers
Under which criteria data/document could be used
for data analysis
From where data/document is obtainable
send email to writer of article for receiving data
What processes are involved for a request to access data/document
after sending email to writer of article, during 1 month, data are sent to him/her