Unique ID issued by UMIN | UMIN000044320 |
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Receipt number | R000050621 |
Scientific Title | An existing and experimental treatment versus a local practice for tungiasis treatment: a randomized controlled trial in Homa Bay, Kenya |
Date of disclosure of the study information | 2021/05/28 |
Last modified on | 2023/06/19 03:57:43 |
A clinical trial with two treatments of tungiasis in Homa Bay, Kenya
A clinical trial with two treatments of tungiasis in Kenya
An existing and experimental treatment versus a local practice for tungiasis treatment: a randomized controlled trial in Homa Bay, Kenya
An existing treatment versus a local practice for tungiasis treatment: a randomized controlled trial in Kenya
Africa |
Tungiasis
Dermatology | Child |
Others
NO
To identify the most acceptable treatment for local treatment in children with tungiasis.
Safety,Efficacy
A difference in cure rate (embedded fleas' viability) on day 12.
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
2
Treatment
Medicine |
dimeticone (NYDA) for the first day
5% sodium carbonate solution for the first day
3 | years-old | <= |
14 | years-old | >= |
Male and Female
-Children who have been infected by tungiasis in Homa Bay, Kenya
-Children who provide written consent to participate in the study (parental consent will also be required)
-Children who have one to five embedded sand flea per foot
-Children with secondary bacterial infection based on the established rapid diagnostic method
-Children infested with massive fleas (more than 10 fleas)
-Children / Caregivers declined to participate
200
1st name | Kana |
Middle name | |
Last name | Suzuki |
Nagasaki University
School of Tropical Medicine and Global Health
852-8523
1-12-4 Sakamoto, Nagasaki
81958197583
ksuzuki@nagasaki-u.ac.jp
1st name | Kana |
Middle name | |
Last name | Suzuki |
Nagasaki University
School of Tropical Medicine and Global Health
852-8523
1-12-4 Sakamoto, Nagasaki
81958197583
ksuzuki@nagasaki-u.ac.jp
Nagasaki University
Not applicable
Other
TMGH ethics review board, Nagasaki University
1-12-4, Sakamoto, Nagasaki
81958197583
tmgh_jimu@ml.nagasaki-u.ac.jp
NO
2021 | Year | 05 | Month | 28 | Day |
Unpublished
Open public recruiting
2021 | Year | 05 | Month | 25 | Day |
2022 | Year | 12 | Month | 07 | Day |
2023 | Year | 01 | Month | 27 | Day |
2023 | Year | 02 | Month | 27 | Day |
Data collection for a pilot study is finished.
About the adverse event, we have informed the Kenyan ethics committee (KEMRI-SERU) of the following.
Five participants got over 38 degree fever during the monitoring period, and one had with cough. All got a consultation with a medical doctor immediately. The medical doctor said there was no relation to the study, and one tested malaria positive. All were given the medication, and the following day, the fever was gone and other events didn't occur.
Next, we will consider whether to move on to the main research after analyzing the results.
2021 | Year | 05 | Month | 25 | Day |
2023 | Year | 06 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050621
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