Effectiveness of Sambucus ebulus Leaf Extract in Treatment of Cutaneous Leishmaniasis: A Double Blind Clinical Trial

Background and purpose: Cutaneous leishmaniasis is a skin disease manifested as chronic ulcerative skin lesions. Current standard therapies for this disease are associated with some problems such as high cost, numerous side effects, need for injections, and drug resistance. Sambucus ebulus is used in treatment of skin inflammation. This study aimed at investigating the effects of S. ebulus leaf extract on cutaneous leishmanisis. Materials and methods: This clinical trial was performed in 110 patients who were divided into intervention (n=55) and control groups (n=55). All patients received the standard treatment for leishmanisis. In addition, the intervention group received topical treatment of S. ebulus leaf extract 5%, while the control group received placebo. The therapy was continued until complete epithelialization of the lesions. Before the intervention and at the end of each week (until complete epithelialization of the lesions), healing progress and clinical characteristics of the lesions, including the size, induration, and degree of epithelialization were recorded. Results: The intervention accelerated the decrease in mean diameter of lesions (P<0.05) but had no significant effect on the mean duration of therapy (P=0.31), treatment outcome (P=0.87), degree of recovery (P= 0.95). Conclusion: The use of S. ebulus leaf extract ointment (5%) along with the standard therapy showed no effect on the treatment outcome of lesions caused by cutaneous leishmaniasis.   (Clinical Trials Registry Number: IRCT20151012024490N2)