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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041018
Receipt No. R000046842
Scientific Title Randomised, parallel-group study to compare the efficacy of coconut oil following diluted hydrogen peroxide 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 2020/07/06

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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 following diluted hydrogen peroxide 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 following diluted oxydol 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 following diluted oxydol 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 NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Coconut oil+ 1.5% hydrogen peroxide diluted oxydol 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 120

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
Email 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
Email ykami@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University
Institute
Department

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
Email 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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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 Preinitiation
Date of protocol fixation
2020 Year 07 Month 05 Day
Date of IRB
Anticipated trial start date
2021 Year 01 Month 25 Day
Last follow-up date
2021 Year 03 Month 19 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
2020 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.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
Registered date File name


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