Evaluation of cutaneous leishmaniasis treatment with Epigallocatechin Gallate compared with the standard group.
Design
Intervention Group 1: Includes ten people with USP hydrophilic ointment (EGCG) (2%) in one of the wounds plus glucantime to increase the effectiveness compared to the other wound of the patient who is treated only with glucantime.
Intervention Group 2: Includes ten people with USP hydrophilic ointment (EGCG) (5%) in one of the wounds plus glucantime to increase the effectiveness compared to the other wound of the patient who is treated only with glucantime.
Settings and conduct
Haft Tir BLV - Villa Street
Participants/Inclusion and exclusion criteria
There are at least two lesions, in one case intervention + glucantime and in the other lesion only glucantime is prescribed.
15 to 60 years
Skin lesions at least one centimeter in size
Leishmaniasis confirmed by a parasitologist
consent signature
Intervention groups
Intervention Group 1: Includes ten people with USP hydrophilic ointment (EGCG) (2%) in one of the wounds plus glucantime to increase the effectiveness compared to the other wound of the patient who is treated only with glucantime.
Intervention Group 2: Includes ten people with USP hydrophilic ointment (EGCG) (5%) in one of the wounds plus glucantime to increase the effectiveness compared to the other wound of the patient who is treated only with glucantime.
Main outcome variables
Twice a week, the lesions is examined by a dermatologist with some index of wound healing. Every three days to 45 days, the final assessment is performed by the research team.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180526039848N2
Registration date:2021-04-27, 1400/02/07
Registration timing:retrospective
Last update:2021-04-27, 1400/02/07
Update count:0
Registration date
2021-04-27, 1400/02/07
Registrant information
Name
Elham Moghaddase
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3884 9410
Email address
moghaddase@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-20, 1399/09/30
Expected recruitment end date
2021-03-09, 1399/12/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the treatment of cutaneous leishmaniasis with Epigallocatechin Gallate, as topical supplemental therapy (A RCT study)
Public title
Evaluation of the treatment of cutaneous leishmaniasis with Epigallocatechin Gallate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
There are at least two lesions, in one case intervention + glucantime and in the other lesion only glucantime is prescribed.
15 to 60 years
Skin lesions at least one centimeter in size
Leishmaniasis confirmed by a parasitologist
consent signature
Exclusion criteria:
People who do not use the drug according to the plan
People who do not go to the clinic on the scheduled days
Age
From 15 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Those who evaluate the outcome are different from those who give the drug to the patient (the doctor gives the medicine) and the consequences will only be written by the code on a separate sheet (the consequences by the code introduced by the student).
The statistician does not know any of the groups and does not know the type of treatment and will only do statistical work with specific codes.
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
Azadi square-medical university
City
Mashhad
Province
Razavi Khorasan
Postal code
13131 - 99137
Approval date
2021-04-10, 1400/01/21
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1400.009
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
lesion size (diameter)
Timepoint
Day of 7، 14، 21، 28، 35، 42
Method of measurement
Image J software
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Includes ten people with EGCGin USP hydrophilic ointment (2%) in one of the wounds plus glucantime to increase the effectiveness compared to the other wound of the patient who is treated only with glucantime.
Category
Treatment - Drugs
2
Description
Intervention group: Includes ten people with EGCGin USP hydrophilic ointment (5%) in one of the wounds plus glucantime to increase the effectiveness compared to the other wound of the patient who is treated only with glucantime.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Haft Tir BLV - Villa Street
Full name of responsible person
Elham Moghaddas
Street address
Haft Tir BLV - Villa Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9179793945
Phone
+98 51 3884 9410
Email
moghaddase@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Elham Moghaddas
Street address
Mashhad.Medical faculty. Parasitology department
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3884 9410
Email
moghaddase@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
Elham Moghaddase
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Parasitology
Street address
medical faculty
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2406
Email
moghaddase@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Elham Moghaddas
Position
associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Parasitology
Street address
Department of Parasitology and Mycology, Faculty of Medicine, Mashhad University
City
mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2406
Email
moghaddase@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Elham Moghaddas
Position
َAssistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Parasitology
Street address
Department of Parasitology and Mycology, Faculty of Medicine, Mashhad University
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2406
Email
moghaddase@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
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
No - There is not a plan to make this available
Title and more details about the data/document
All images of patients' wounds during treatment
When the data will become available and for how long
Up to 1 year after the completion of the project
To whom data/document is available
Project collaborators
Under which criteria data/document could be used
Have a face-to-face conversation with project executives about your idea
From where data/document is obtainable
Have a written request or in person with the project executors
What processes are involved for a request to access data/document
A written request should be given to the executors of the project