UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049323 |
|---|---|
| Receipt number | R000056170 |
| Scientific Title | Effect of bathing method using bath preparation containing rice extract on pruritus in patients receiving hemodialysis |
| Date of disclosure of the study information | 2022/10/26 |
| Last modified on | 2024/05/18 01:05:28 |
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Basic information
Public title
Effect of bathing method using bath preparation containing rice extract on pruritus in patients receiving hemodialysis
Acronym
Effect of bathing method using bath preparation containing rice extract
Scientific Title
Effect of bathing method using bath preparation containing rice extract on pruritus in patients receiving hemodialysis
Scientific Title:Acronym
Effect of bathing method using bath preparation containing rice extract
Region
| Japan |
Condition
Condition
End stage kidney disease
Classification by specialty
| Nephrology | Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of bathing method using bath preparation containing rice extract on pruritus in patients receiving hemodialysis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
VAS score of severity of pruritus after the implementation of bathing method using bath preparation containing rice extract for 4 weeks
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Use of bath preparation containing rice extract (Non-dialysis days, 4 days/week, for 4 weeks)
Interventions/Control_2
Not use of bath preparation containing rice extract (Non-dialysis days, 4 days/week, for 4 weeks)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients who are undergoing hemodialysis for at least 6 months.
2.Patients with pruritus.
3.Japanese males and females aged over 20 years old at the time of informed consent.
4.Patients who agree to participate in this study with a written informed consent after receiving sufficient explanation relating to this study.
Key exclusion criteria
1.Patients who are not allowed to take a bath by physician.
2.Patients who underwent any changes that were considered to affect the severity of pruritus (prescription of antihistamines, nalfurafine hydrochloride, topical steroids, or moisturizers, or dialysis conditions) during the study period.
3.Patients who are deemed inappropriate by the principal investigator.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Katsuya |
| Middle name | |
| Last name | Yamauchi |
Organization
Yamauchi pharmacy
Division name
Yamauchi pharmacy
Zip code
420-0838
Address
8-7 Aioi-cho, Aoi-ku, Shizuoka 420-0838, Japan
TEL
054-200-0255
rinbokukan@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Suzuki |
Organization
Yamauchi pharmacy
Division name
Yamauchi pharmacy
Zip code
420-0838
Address
8-7 Aioi-cho, Aoi-ku, Shizuoka 420-0838, Japan
TEL
054-200-0255
Homepage URL
rinbokukan@yahoo.co.jp
Sponsor or person
Institute
Yamauchi pharmacy
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of the Tokokai medical corporation association
Address
9-5 Aioi-cho, Aoi-ku, Shizuoka 420-0838, Japan
Tel
054-247-2785
hm-yamauchi@fmwbs.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
| 2022 | Year | 10 | Month | 26 | 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
13
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
No adverse events were observed in the participants.
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 26 | Day |
Last modified on
| 2024 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056170
