UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041018 |
|---|---|
| Receipt number | R000046842 |
| Scientific Title | Randomised, parallel-group study to compare the efficacy of coconut oil versus potassium permanganate for the treatment of tungiasis in children in Homa Bay County, Kenya |
| Date of disclosure of the study information | 2020/07/10 |
| Last modified on | 2024/01/09 12:54:14 |
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Basic information
Public title
Comparative study on coconut oil versus potassium permanganate for the treatment of tungiasis in children in Homa Bay County, Kenya
Acronym
Comparison of coconut oil versus potassium permanganate for tungiasis in Kenya
Scientific Title
Randomised, parallel-group study to compare the efficacy of coconut oil versus potassium permanganate for the treatment of tungiasis in children in Homa Bay County, Kenya
Scientific Title:Acronym
Randomised, clinical study to compare coconut oil versus potassium permanganate for tungiasis in children in Kenya
Region
| Africa |
Condition
Condition
tungiasis
Classification by specialty
| Dermatology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine if coconut oil is superior to KMnO4 solution for topical treatments for tungiasis in school-age children in Homa Bay, Kenya
To assess the safety of coconut oil and KMnO4 solution in children with tungiasis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Treatment-induced change (improvement or deterioration) in the skin condition affected by tungiasis within 2 weeks
Key secondary outcomes
Development of adverse events/effects and symptomatic improvements within 2 weeks
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Coconut oil for the fist 3 days
Interventions/Control_2
0.05% potassium permanganate (KMnO4) solution, only once at the beginning
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
| 8 | years-old | <= |
Age-upper limit
| 14 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Children with an established diagnosis of tungiasis with stage II or IIIa based on rapid assessment by Fortaleza classification, which describes flea viability signs such as pulsation of the abdomen, expulsion of eggs, and excretion of a faecal thread.
Key exclusion criteria
Children with severe tungiasis including those with infestation with 10 or more fleas, and any disability preventing active cooperation in the study and those who have received treatment four weeks before the intervention and allergic to any of the treatments studied will be excluded. The severe cases will be referred to the Subcounty hospital for further clinical treatment.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiko |
| Middle name | |
| Last name | Kamiya |
Organization
Nagasaki University
Division name
School of Tropical Medicine & Global Health
Zip code
852-8523
Address
1-12-4 Sakamoto, Nagasaki
TEL
81958197891
ykami@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuhiko |
| Middle name | |
| Last name | Kamiya |
Organization
Nagasaki University
Division name
School of Tropical Medicine & Global Health
Zip code
852-8523
Address
1-12-4 Sakamoto, Nagasaki
TEL
81958197891
Homepage URL
ykami@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University School of Tropical Medicine & Global Health Ethics Committee
Address
1-12-4 Sakamoto, Nagasaki
Tel
81958197583
tmgh_jimu@ml.nagasaki-u.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 10 | Day |
Related information
URL releasing protocol
not yet
Publication of results
Unpublished
Result
URL related to results and publications
not yet
Number of participants that the trial has enrolled
0
Results
The clinical trial has not yet conducted
Results date posted
| 2023 | Year | 01 | Month | 07 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
due to COVID-19 pandemic
Date of the first journal publication of results
Baseline Characteristics
not yet determined
Participant flow
not yet determined
Adverse events
not yet occurred
Outcome measures
not yet conducted
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2020 | Year | 07 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 07 | Month | 06 | Day |
Last modified on
| 2024 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046842
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
