Evaluating the effectiveness of intralesional injection of Glucantime® plus cotton boll extract compared to intralesional injection of Glucantime® plus cryotherapy in patients infected with Leishmania tropica
Evaluating the effect of Cotton boll extract compared to cryotherapy in healing of Cutaneous lesions by Leishmania tropica
Design
Phase 3; Open label randomized control trial with 120 samples that randomized by online block randomization generator
Settings and conduct
Study will be conducted in Kerman city leishmanial treatment center and patient with skin lesions by Leishmania tropica enroll by inclusion criteria and divide randomly into intervention and control groups. intervention group receive standard intralesional injection of Glucantime® plus 10% topical cotton boll extract for 8 weeks. Control group receive standard intralesional injection of Glucantime® plus cryotherapy for 8 weeks
Participants/Inclusion and exclusion criteria
Inclusion criteria: Infection by Leishmania tropica, Age within 8 to 60 years, Number of skin lesions less than 5, Size of lesions less than 5 centimeters, Duration of lesions less than 3 months, Receiving no anti-leishmanial remedies during past 3 months, Completing of informed consent form
Exclusion criteria: Pregnancy and Lactation; Underlying diseases and Allergy; Lesions on joint or face and sensitive organs; Regional adenopathy
Intervention groups
Patients in intervention group receive 10% Topical cotton boll extract
Patients in control group receive lesion Cryotherapy
Intervention and control groups receive Intralesional injection of Glucantime®
Main outcome variables
Size of wound; Induration of wound; Healing time
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230903059337N2
Registration date:2023-10-24, 1402/08/02
Registration timing:prospective
Last update:2023-10-24, 1402/08/02
Update count:1
Registration date
2023-10-24, 1402/08/02
Registrant information
Name
Mehdi Shafiei_bafti
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3131 5724
Email address
kmushafiei51@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2025-08-21, 1404/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effectiveness of intralesional injection of Glucantime® plus cotton boll extract compared to intralesional injection of Glucantime® plus cryotherapy in patients infected with Leishmania tropica
Public title
Effect of Cotton boll extract in treatment of Cutaneous leishmaniasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients infected by Leishmania tropica
Number of skin lesions less than 5
Size of lesions less than 5 centimeters
Duration of lesions less than 3 months
Receiving no anti-leishmania remedies during the past 3 months
Completing the informed consent form
Exclusion criteria:
Pregnancy and Lactation
Underlying diseases and Allergy
Lesions on joint, face and sensitive organs
Regional adenopathy
Age
From 8 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into intervention and control group with Blocked randomization method by online block randomization generator
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 Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2023-10-23, 1402/08/01
Ethics committee reference number
IR.IUMS.REC.1402.643
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
Size of induration
Timepoint
In 0, 4, 8, 12 weeks of treatment
Method of measurement
By digital caliper
2
Description
Size of wound
Timepoint
In 0, 4, 8, 12 weeks of treatment
Method of measurement
Wound Desk app
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intralesional injection of Glucantime® weekly for 8 weeks plus topical use of 10% Cotton boll extract twice a day for 8 weeks
Category
Treatment - Drugs
2
Description
Control group: Intralesional injection of Glucantime® weekly for 8 weeks plus Cryotherapy once every two weeks for 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Leishmania treatment center
Full name of responsible person
Mehdi Shafiei_bafti
Street address
Leishmania treatment center, Behzad st.
City
Kerman
Province
Kerman
Postal code
7618747654
Phone
+98 34 3323 0990
Email
kmushafiei51@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Reza Falak
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2504
Email
falak.r@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Mehdi Shafiei_bafti
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
School of Persian Medicine, No. 847, Behesht Ave., Abusaid St.
City
Tehran
Province
Tehran
Postal code
1114733311
Phone
+98 21 5558 0388
Email
kmushafiei51@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Taghavi Shirazi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
School of Persian Medicine, No. 847, Behesht Ave., Abusaid St.
City
Tehran
Province
Tehran
Postal code
1114733311
Phone
+98 21 5558 0388
Email
mtaghavish@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mehdi Shafiei_bafti
Position
Ph.D Student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
School of Persian Medicine, No. 847, Behesht Ave., Abusaid St.
City
Tehran
Province
Tehran
Postal code
1114733311
Phone
+98 21 5558 0388
Email
kmushafiei51@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Research data can be shared as an Excel file without personal information
When the data will become available and for how long
6 months after Publication
To whom data/document is available
Academic Researchers
Under which criteria data/document could be used
For statistical analysis and papers with declaring the data source
From where data/document is obtainable
School of Persian medicine, Iran University of Medical Sciences
What processes are involved for a request to access data/document