Protocol summary
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Study aim
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Evaluating the effect of Cotton boll extract compared to cryotherapy in healing of Cutaneous lesions by Leishmania tropica
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Design
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Phase 3; Pilot Open label randomized control trial with 24 samples that randomized by online block randomization generator
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Settings and conduct
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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
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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®
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Main outcome variables
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Size of wound; Induration of wound; Healing time
General information
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Reason for update
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Sample size change
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20230903059337N2
Registration date:
2023-10-24, 1402/08/02
Registration timing:
prospective
Last update:
2025-10-07, 1404/07/15
Update count:
1
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Registration date
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2023-10-24, 1402/08/02
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-12-22, 1402/10/01
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Expected recruitment end date
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2025-08-21, 1404/05/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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Effect of Cotton boll extract in treatment of Cutaneous leishmaniasis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 8 years old to 60 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
24
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients will be divided into intervention and control group with Blocked randomization method by online block randomization generator
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-10-23, 1402/08/01
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Ethics committee reference number
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IR.IUMS.REC.1402.643
Health conditions studied
1
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Description of health condition studied
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Cutaneous leishmaniasis
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ICD-10 code
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B55.1
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ICD-10 code description
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Cutaneous leishmaniasis
Primary outcomes
1
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Description
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Size of induration
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Timepoint
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In 0, 4, 8, 12 weeks of treatment
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Method of measurement
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By digital caliper
2
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Description
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Size of wound
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Timepoint
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In 0, 4, 8, 12 weeks of treatment
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Method of measurement
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Wound Desk app and digital caliper
Intervention groups
1
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Description
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Intervention group: Intralesional injection of Glucantime® weekly for 8 weeks plus topical use of 10% Cotton boll extract twice a day for 8 weeks
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Category
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Treatment - Drugs
2
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Description
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Control group: Intralesional injection of Glucantime® weekly for 8 weeks plus Cryotherapy once every two weeks for 8 weeks
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Research data can be shared as an Excel file without personal information
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When the data will become available and for how long
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6 months after Publication
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To whom data/document is available
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Academic Researchers
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Under which criteria data/document could be used
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For statistical analysis and papers with declaring the data source
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From where data/document is obtainable
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School of Persian medicine, Iran University of Medical Sciences
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What processes are involved for a request to access data/document
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Sending an official request to announced address
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Comments
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