title: Exploratory, Phase II Controlled Trial of Shiunko Ointment Local Application Twice a Day for 4 Weeks in Ethiopian Patients with Localized Cutaneous Leishmaniasis.
abstract: The clinical efficacy and safety of Shiunko ointment (phase II clinical trial) was investigated in 40 Ethiopian patients with cutaneous leishmaniasis. Patients were randomized to receive treatment with Shiunko ointment or placebo (n = 20, each), applied on the lesion twice a day for 4 weeks. Clinicoparasitological assessments were performed before treatment, weekly for 4 weeks, and then 4, 8, and 12 weeks after the end of treatment. A marked reduction in lesion size was observed on week 16 of treatment in the Shiunko compared with placebo group (69% and 22% reduction, resp.). The overall rate of lesion reduction during the four weeks of treatment was significantly faster in the Shiunko group. Shiunko provided significant effect on wound closure in patients with ulcerated lesion. The clinical efficacy and tolerability of Shiunko were comparable to placebo with regard to its clinicoparasitological response (cure rate and parasitological clearance). Results of this preliminary study may suggest that Shiunko could be useful as adjuvant or as complementary treatment, not as alternatives to current treatment. Its attractive action includes fast lesion healing with a significantly smaller lesion at week 16 of treatment compared with placebo. In addition, its action was promoted in ulcerative lesions.
authors.affiliation: Graduate Studies, Chulabhorn International College of Medicine, Center of Excellence in Pharmacology and Molecular Biology of Malaria and Cholangiocarcinoma, Thammasat University, Pathum Thani 12121, Thailand.
authors.forename: Kesara
authors.initials: K
authors.lastname: Na-Bangchang
authors.affiliation: Armauer Hansen Research Institute (AHRI), 1000 Addis Ababa, Ethiopia.
authors.forename: Oumer
authors.initials: O
authors.lastname: Ahmed
authors.affiliation: Armauer Hansen Research Institute (AHRI), 1000 Addis Ababa, Ethiopia.
authors.forename: Jemal
authors.initials: J
authors.lastname: Hussein
authors.affiliation: Department of Immunogenetics, Institute of Tropical Medicine (NEKKEN), Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki 852-8523, Japan.
authors.forename: Kenji
authors.initials: K
authors.lastname: Hirayama
authors.affiliation: Graduate Studies, Chulabhorn International College of Medicine, Center of Excellence in Pharmacology and Molecular Biology of Malaria and Cholangiocarcinoma, Thammasat University, Pathum Thani 12121, Thailand.
authors.forename: Panida
authors.initials: P
authors.lastname: Kongjam
authors.affiliation: Armauer Hansen Research Institute (AHRI), 1000 Addis Ababa, Ethiopia.
authors.forename: Abraham
authors.initials: A
authors.lastname: Aseffa
authors.affiliation: Clinical Product Development, Institute of Tropical Medicine (NEKKEN), Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki 852-8523, Japan.
authors.forename: Juntra
authors.initials: J
authors.lastname: Karbwang