UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010994 |
|---|---|
| Receipt number | R000012855 |
| Scientific Title | 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. |
| Date of disclosure of the study information | 2013/06/18 |
| Last modified on | 2014/12/09 17:01:20 |
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Basic information
Public title
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.
Acronym
Shiunko Project
Scientific Title
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.
Scientific Title:Acronym
Shiunko Project
Region
| Africa |
Condition
Condition
Cutaneous Leishmaniasis.
Classification by specialty
| Infectious disease | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of Shiunko ointment when applied on the lesion twice a day for 4 weeks in patients with localized Cutaneous Leishmaniasis.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Cure rate
Key secondary outcomes
Safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Shiunko ointment
Interventions/Control_2
Placebo
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Presence of new , active lesion , localized solid cutaneous leishmaniasis lesion on exposed sites like face, extremities, diagnosed by staining techniques on lesion aspirate or smear from scraping on the index lesion and PCR, with no previous treatment in the past 6 months
2. Age: 18 - 65 years
3. Has an identifiable address and expects to remain in the area for the duration of the study.
Key exclusion criteria
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
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Oumer Ali |
Organization
Armauer Hansen Research Institute ALERT
Division name
Clinical Trial Center
Zip code
Address
P.O. Box 1005.Addis Ababa, Ethiopia
TEL
251-113211-334
oumer2003@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Juntra Karbwang Laothavorn |
Organization
Nagasaki University
Division name
Clinical Product Development Department
Zip code
Address
1-12-4 Sakamoto Nagasaki Japan
TEL
095-819-7558
Homepage URL
kawbwangj@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Nagasaki University(長崎県)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 02 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2014 | Year | 01 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 02 | Month | 13 | Day |
Date trial data considered complete
| 2014 | Year | 03 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 11 | Month | 04 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 06 | Month | 18 | Day |
Last modified on
| 2014 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012855
