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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000024188 |
Receipt No. | R000027699 |
Scientific Title | Evaluating artificial carbonated shower for dermal pruritus in dialysis patients |
Date of disclosure of the study information | 2016/10/01 |
Last modified on | 2016/09/27 |
Basic information | ||
Public title | Evaluating artificial carbonated shower for dermal pruritus in dialysis patients | |
Acronym | Effectiveness of artificial carbonated shower treatment for dermal pruritus in dialysis patients | |
Scientific Title | Evaluating artificial carbonated shower for dermal pruritus in dialysis patients | |
Scientific Title:Acronym | Effectiveness of artificial carbonated shower treatment for dermal pruritus in dialysis patients | |
Region |
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Condition | |||
Condition | Dermal pruritus | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | The purpose of this study is to establish the treatment with artificial carbonated shower (CO2 shower) for dermal pruritus in dialysis patients. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | itch level on a VAS-scalea |
Key secondary outcomes | IgE,BUN,Cr,B2-MG,Ca,P,int-PTH,ferritin,CRP,HRT,white blood celldiff erentiation |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Patients take a CO2 shower using an artificial CO2 water producer every day for four weeks. The duration of one session is at least five minutes. | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | The subjects will be selected from 50 or more patients who are picked up based on the results of visual analogue scale (VAS) questionnaire to all patients of subjected facilities and who agree with our study.
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Key exclusion criteria | In case a patient does not agree with our study | |||
Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kaikoukai Medical Foundation | ||||||
Division name | Department of Dialysis Department, | ||||||
Zip code | |||||||
Address | 1-161 Hokke,Nakagawa,Nagoya City | ||||||
TEL | 052-363-7211 | ||||||
tyamada@touseki.jp |
Public contact | |||||||
Name of contact person |
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Organization | Kaikoukai Medical Foundation | ||||||
Division name | Nagoya Kyoritsu Hospital | ||||||
Zip code | |||||||
Address | 1-172 Hokke,Nakagawa,Nagoya City | ||||||
TEL | 052-362-5151 | ||||||
Homepage URL | http://www.kaikou.or.jp/index.html | ||||||
ymoriyama@kaikou.or.jp |
Sponsor | |
Institute | Kaikoukai Medical Foundation |
Institute | |
Department |
Funding Source | |
Organization | Kaikoukai Medical Foundation |
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 | |
Address | |
Tel | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027699 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |