Treatment of antroponotic cutaneous leishmanasis resistant classes with oral miltefosine
Design
Randomized Controlled Trial
Settings and conduct
Patient who do not respond glugantim treatment at Ghaeme Hospital in Mashhad will first be asked for a polymerase chain reaction (PCR ) test and after the tests confirmation, the initial test for liver and kidney and cell blood count (CBC) would be asked and if they were normal, we will start a 28-day oral miltefosine course (by weight)
Participants/Inclusion and exclusion criteria
Entrance Standard: People over two years old;.
Exit Standard: 1- Pragnansy 2- Lactation 3- Renal، Kidny and Heart Disorder 4- Cytopenia
Intervention groups
Patients with leishmaniasis who were resistance with two courses of systemic glocantim therapy was threaded by a 28-day course of oral multifocin
Main outcome variables
Indoration Change , Side effect of treatment , Control of urea creatinine tests ,Liver enzyme, Blood cell count
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200302046673N1
Registration date:2020-05-10, 1399/02/21
Registration timing:retrospective
Last update:2020-05-10, 1399/02/21
Update count:0
Registration date
2020-05-10, 1399/02/21
Registrant information
Name
Masoume Tayebi
Name of organization / entity
Country
United States of America
Phone
+1 513-867-5473
Email address
tayyebims961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
2019-05-22, 1398/03/01
Actual recruitment end date
2019-10-26, 1398/08/04
Trial completion date
2020-10-25, 1399/08/04
Scientific title
Effect of oral miltefosin on treatment of chronic anthropological cutaneous leishmaniasis
Public title
The effect of oral miltefosin on treatment resistant cutaneous leishmaniasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Individuals with antroponotic leishmaniasis over two year who have not received remission despite two courses of systemic glucontime or one cours of systemic glugantime plus one course of intraleasional injection
Exclusion criteria:
Children Under Two Year
Pregnancy and Lactation
Renal Disorer
Liver Disorder
Heart Disease
Cytopenia
Age
From 2 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
27
Actual sample size reached:
27
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
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
Fakuri Boulevard 8, Villa 9, No. 2
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۷۹۱۵۴۵۱۴
Approval date
2018-11-20, 1397/08/29
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1398.604
Health conditions studied
1
Description of health condition studied
Cutaneous Leishmaniasis Antroponotic
ICD-10 code
B55.1
ICD-10 code description
Cutaneous Leishmaniasis
Primary outcomes
1
Description
Endoration Rate of Leasion
Timepoint
Study days 0,14,28,90,180,360
Method of measurement
Ruler
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group: Miltefosin made in PROFONDA Co.in India 50 mg. 2.5mg/kg/day for 28 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Vahid Mashayekhi Ghoyonlo
Street address
Fakuri Boulevard 8, Villa 9, No. 2
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۷۹۱۵۴۵۱۴
Phone
+98 51 3867 5473
Fax
+98 51 3867 5473
Email
Tayyebims961@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vakilabad Highway - Azadi Square - University Campus - Medical School
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۷۷۹۴۸۵۶۴
Phone
+98 51 3882 8888
Email
Tayyebims961@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
100
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
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vakilabad Highway - Azadi Square - University Campus - Medical School
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۷۷۹۴۸۵۶۴
Phone
+98 51 3882 8888
Email
Tayyebims961@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
100
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
Masoume Tayebi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Fakuri Boulevard 8, Villa 9, No. 2
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۷۹۱۵۴۵۱۴
Phone
+98 51 3867 5473
Email
Tayyebims961@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Masoume Tayebi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Fakuri Boulevard 8, Villa 9, No. 2
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۷۹۱۵۴۵۱۳
Phone
+98 51 4867 5473
Email
Tayyebims961@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Masoume Tayebi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Fakuri Boulevard 8, Villa 9, No. 2
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۷۹۱۵۴۵۱۴
Phone
+98 51 3867 5473
Email
Tayyebims961@mums.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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available