The effect of Berberis Vulgaris extract, on Cutaneous Leishmaniasis

The Effect of Berberis Vulgaris hydro alcoholic extract, On Cutaneous Leishmaniasis patients in comparison with Glucantime and Placebo: A Clinical Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2015060122512N1

Enrollment

120

Registered

2017-06-19

Start date

2015-02-18

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cutaneous Leishmaniasis. Cutaneous Leishmaniasis

Interventions

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

Treatment - Drugs

Control group: injection of intralesional meglumine antimoniate (glucantime) weekly for 8 weeks and topical use of placebo three times daily for 8 weeks

Intervention group: topical use of Berberis Vulgaris extract three times daily for 8 weeks

Intervention group: injection of intralesional Glucantime weekly for 8 weeks and topical use of Berberis Vulgaris extract three times daily for 8 weeks

Eligibility

Sex/Gender

All

Age

12 Years to No maximum

Inclusion criteria

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

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Lesion size change. Timepoint: Weekly until 8 weeks. Method of measurement: Measuring the size of induration and ulcer by caliper.	—

Secondary

Measure	Time frame
Side effects: erythema, itching. Timepoint: Weekly. Method of measurement: Clinical evaluation.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Masoud Maleki

Dermatology Department & Cutaneous Leishmaniasis Research Center, Mashhad University of Medical Scie

malekim@mums.ac.ir+98 51 3802 2510

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026