UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044184 |
|---|---|
| Receipt number | R000050458 |
| Scientific Title | Anti-odor effect of rice bran sheets for urine bag |
| Date of disclosure of the study information | 2021/05/12 |
| Last modified on | 2024/05/14 14:43:58 |
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Basic information
Public title
Anti-odor effect of rice bran sheets for urine bag
Acronym
Anti-odor effect of rice bran sheets for urine bag
Scientific Title
Anti-odor effect of rice bran sheets for urine bag
Scientific Title:Acronym
Anti-odor effect of rice bran sheets for urine bag
Region
| Japan |
Condition
Condition
urethral catheter
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For patients with urethral catheters, the deodorant effect of rice bran-containing sheets will be investigated.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of patient's subjective symptoms
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Covering the urethral catheter bag with a rice bran-containing cover for 7 days.
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with urethral catheter
Key exclusion criteria
Patients with olfactory dysfunction
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Sho |
| Middle name | |
| Last name | Hayashida |
Organization
Shimane University, Faculty of Medicine
Division name
Plastic and Reconstructive Surgery
Zip code
6938501
Address
89-1 Enya-cho, Izumo, Shimane
TEL
0853883017
kenji@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Hayashida |
Organization
Shimane University, Faculty of Medicine
Division name
Plastic and Reconstructive Surgery
Zip code
6938501
Address
89-1 Enya-cho, Izumo, Shimane
TEL
0853883017
Homepage URL
kenji@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
Funding Source
Organization
Shiraishi Biomass
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shimane University, Faculty of Medicine
Address
89-1 Enya-cho, Izumo, Shimane
Tel
0853883017
kenji@med.shimane-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
| 2021 | Year | 05 | Month | 12 | 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
15
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
Completed
Date of protocol fixation
| 2021 | Year | 05 | Month | 12 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 22 | Day |
Date of closure to data entry
| 2023 | Year | 05 | Month | 22 | Day |
Date trial data considered complete
| 2023 | Year | 05 | Month | 22 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 05 | Month | 12 | Day |
Last modified on
| 2024 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050458
