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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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IRCT |
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Last refreshed on:
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22 February 2018 |
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Main ID: |
IRCT2015060122512N1 |
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Date of registration:
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2017-06-19 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The effect of Berberis Vulgaris extract, on Cutaneous Leishmaniasis
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Scientific title:
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The Effect of Berberis Vulgaris hydro alcoholic extract, On Cutaneous Leishmaniasis patients in comparison with Glucantime and Placebo: A Clinical Trial |
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Date of first enrolment:
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2015-02-18 |
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Target sample size:
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120 |
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Recruitment status: |
Complete |
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URL:
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http://en.irct.ir/trial/19404 |
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Study type:
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interventional |
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Study design:
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Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.
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Phase:
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3
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Countries of recruitment
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Iran (Islamic Republic of)
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Contacts
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Name:
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Dr Masoud Maleki
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Address:
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Dermatology Departmen, Imam Reza hospital, Ebne Sina Street
Mashhad
Iran (Islamic Republic of) |
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Telephone:
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+98 51 3802 2510 |
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Email:
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malekim@mums.ac.ir |
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Affiliation:
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Dermatology Department & Cutaneous Leishmaniasis Research Center, Mashhad University of Medical Scie |
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Name:
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Dr Masoud Maleki
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Address:
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Dermatology Department, Imam Reza hospital, Ebne Sina Street
Mashhad
Iran (Islamic Republic of) |
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Telephone:
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+98 51 3802 2510 |
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Email:
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malekim@mums.ac.ir |
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Affiliation:
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Mashhad University of Medical Sciences |
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Key inclusion & exclusion criteria
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Inclusion criteria: Inclusion criteria: Presence of cutaneous leishmaniasis with less than 6 months of clinical course; Not receive any treatment 3 months before; Age 8 years and above; Lesion diameter less than 3 cm; The number of lesion less than 5; The lesion on the limbs and trunk with the exception of joints’ surface.
Exclusion criteria: Pregnancy; Lactating; Receiving simultaneous treatment with other methods during treatment course; History of significance renal, Pulmonary and cardiovascular disease; Create a secondary infection of the wound; Deterioration of the condition of the patient during the study; Immune suppressor drugs consumption; Do not run commands therapy.
Exclusion criteria:
Age minimum:
12 years
Age maximum:
no limit
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cutaneous Leishmaniasis
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Cutaneous Leishmaniasis.
Cutaneous Leishmaniasis
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Intervention(s)
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Intervention group: injection of intralesional Glucantime weekly for 8 weeks and topical use of Berberis Vulgaris extract three times daily for 8 weeks
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Treatment - Drugs
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Intervention 1: Intervention group: topical use of Berberis Vulgaris extract three times daily for 8 weeks. Intervention 2: Intervention group: injection of intralesional Glucantime weekly for 8 weeks and topical use of Berberis Vulgaris extract three times daily for 8 weeks. Intervention 3: Control group: injection of intralesional meglumine antimoniate (glucantime) weekly for 8 weeks and topical use of placebo three times daily for 8 weeks.
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Intervention group: topical use of Berberis Vulgaris extract three times daily for 8 weeks
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Control group: injection of intralesional meglumine antimoniate (glucantime) weekly for 8 weeks and topical use of placebo three times daily for 8 weeks
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Primary Outcome(s)
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Lesion size change. Timepoint: Weekly until 8 weeks. Method of measurement: Measuring the size of induration and ulcer by caliper.
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Secondary Outcome(s)
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Side effects: erythema, itching. Timepoint: Weekly. Method of measurement: Clinical evaluation.
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Source(s) of Monetary Support
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Mashhad University of Medical Sciences, Vice Chancellor for Research
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Ethics review
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Status: Approved
Approval date:
Contact:
Ethics Committee of Mashhad University of Medical Sciences
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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