Assessing the effectiveness of Sambucus Ebulus ointment in treatment of Leishmaniasis

Determine the effectiveness of Sambucus Ebulus ointment in treatment of Leishmaniasis

This study will be a randomized double blind clinical trial on 90 patients come down with cutaneous leishmaniasis which refer to Gonbad Kavoos Cutaneous Leishmaniasis Treatment Center in 2017-2018. Patients randomly will be divided in two groups: cases and controls. All patients will be underwent standard treatment for cutaneous leishmaniasis (based on national guideline). Cases will give Sambucus Ebulus ointment and controls will give placebo. Medication will be continue until the full lesion epithelialization or 4 weeks after last intervention. Patient demographic information and morphological information of lesion (including the number of lesions, location, shape, and duration of lesions), the lesions healing and treatment result and clinical data will be recorded at the begining of the treatment, at the end of the first week, second, third, fourth (and if not cure happened at the end of forth week after the last intervention) wound healing and clinical information (including the size of the lesion, the size of the induration and the epithelialization) will be measured and recorded.

This study will be a randomized double blind clinical trial on 90 patients come down with cutaneous leishmaniasis which refer to Gonbad Kavoos Cutaneous Leishmaniasis Treatment Center in 2017-2018.

Inclusion criteria: Patients with lesions which lasts more than 14 days and definitely diagnosed cutaneous leishmaniasis by parasites seen in smears taken from skin lesions, and treating by the national standard treatment guidelines, after complete description of the study, in the case of consent to participate in the study are؛ Exclusion criteria: Pregnant women, patients with allergy to antimuan, patients taking more than three months have passed since the first appearance of skin lesions, patients in recent months any way be used to treat leishmaniasis, patients which their wound on the eyelids, ear, nose or are less than one centimeter is near the end of the lips and eyes.

Intervention group: Sambucus Ebulus 5% ointment two times a day a layer until the full lesion epithelialization or up to 4 weeks after last intervention. Control group: Placebo ointment two times a day a layer until the full lesion epithelialization or up to 4 weeks after last intervention.

longest diameter of ulceration area; longest diameter of Induration area; Healing rate; treatment resualt will be measured in 0,7,14,21,28 day& if not cured 4 week after last intervention.

Vice chancellor for research, Mazandaran University of Medical Sciences

Randomization will be performed by using the random number tables.

In this survey patient and researcher are blind and drug and placebo would coding by Pharmacist.

No more information