Effectiveness of Sambucus Ebulus leaf extract ointment in treatment results of Cutaneous Leishmaniasis

Comparing the effectiveness of Sambucus Ebulus leaf extract ointment and placebo, in treatment results of Cutaneous Leishmaniasis; A double blind clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20151012024490N2

Enrollment

110

Registered

2018-01-01

Start date

2017-12-06

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: Sambucus Ebulus leaf extract ointment. In order to prepare the ointment, a 5% extract of the plant leaves in vaseline (and liquid paraffin) will be used. This drug will be made at Maza

Treatment - Drugs

Sambucus Ebulus leaf extract ointment. In order to prepare the ointment, a 5% extract of the plant leaves in vaseline (and liquid paraffin) will be used. This drug will be made at Mazandaran Universit

Placebo ointment contains the base compound (Vaseline and liquid paraffin) that will be similar to the drug in shape and smell and only the active ingredient will be absent. This placebo will be made

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients with confirmed cutaneous leishmaniasis diagnosis

Exclusion criteria

Exclusion criteria: pregnant women patients with allergy to antimuan passing more than three months from the first existence of skin lesions getting any treatment for leishmaniasis in recent month patients whose wounds are on the eyelids, ear, nose or near the end of the lips and eyes (less than one centimeter)

Design outcomes

Primary

Measure	Time frame
Longest diameter of ulceration area. Timepoint: At the first, 7th, 14th, 21th, 28th day of the treatment. And at 28th day after last treatment intervention, if the wound doesn't heal within first 4 weeks. Method of measurement: ruler.;Longest diameter of Induration area. Timepoint: At the first, 7th, 14th, 21th, 28th day of the treatment. And at 28th day after last treatment intervention, if the wound doesn't heal within first 4 weeks. Method of measurement: ruler.;Healing rate. Timepoint: At the first, 7th, 14th, 21th, 28th day of the treatment. And at 28th day after last treatment intervention, if the wound doesn't heal within first 4 weeks. Method of measurement: observation & calculation.;Treatment result. Timepoint: During treatment or during 4 weeks after treatment. Method of measurement: observation & calculation.;Healing rate. Timepoint: During treatment or during 4 weeks after treatment. Method of measurement: observation & calculation.	—

Measure

Time frame

Longest diameter of ulceration area. Timepoint: At the first, 7th, 14th, 21th, 28th day of the treatment. And at 28th day after last treatment intervention, if the wound doesn't heal within first 4 weeks. Method of measurement: ruler.;Longest diameter of Induration area. Timepoint: At the first, 7th, 14th, 21th, 28th day of the treatment. And at 28th day after last treatment intervention, if the wound doesn't heal within first 4 weeks. Method of measurement: ruler.;Healing rate. Timepoint: At the first, 7th, 14th, 21th, 28th day of the treatment. And at 28th day after last treatment intervention, if the wound doesn't heal within first 4 weeks. Method of measurement: observation & calculation.;Treatment result. Timepoint: During treatment or during 4 weeks after treatment. Method of measurement: observation & calculation.;Healing rate. Timepoint: During treatment or during 4 weeks after treatment. Method of measurement: observation & calculation.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSafoora Saberi

Gorgan University of Medical Sciences

dr.mozafari@goums.ac.ir+98 17 3328 6852

Outcome results

None listed

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