Double blinded randomised placebo controlled phase II trial of Shiunko Ointment local application twice a day for 4 weeks in Ethiopian patients with localized cutaneous Leishmaniasis. - Shiunko Project

Forty patients with cutaneous leishmaniasis (CL) (62.5% male, aged 18-62 years) were recruited and then randomized to receive either placebo or Shiuko treatment. In the first four weeks of treatment period, the rate of lesion reduction was significantly faster in the Shiunko compared with placebo. Clinical efficacy of Shiunko vs. placebo based on intention-to-treat and per-protocol analysis were similar with regard to proportions of patients with cure. No significant change in laboratory parameters in both groups was found. The frequencies of adverse events were not different between both groups.