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.
- Conditions
- Cutaneous Leishmaniasis.
- Registration Number
- JPRN-UMIN000010994
- Lead Sponsor
- agasaki University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Not provided
1.Patients with multiple lesions,mucocutaneousand/or diffused Cutaneous Leishmaniasis 2.Abnormal biochemical and/or haematological laboratory values and considered clinically relevant. 3.Any condition which to comply with the study procedures. 4.Known hypersensitivity to any of the trial product components. 5.Pregnancy as confirmed by urine HCG in female of reproductive age
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method