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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

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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
Japan

Condition
Condition Dermal pruritus
Classification by specialty
Nephrology Dermatology
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
Other
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
30 years-old <=
Age-upper limit
90 years-old >
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.
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
1st name
Middle name
Last name tetsuya yamada
Organization Kaikoukai Medical Foundation
Division name Department of Dialysis Department,
Zip code
Address 1-161 Hokke,Nakagawa,Nagoya City
TEL 052-363-7211
Email tyamada@touseki.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshifumi Moriyama
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
Email 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
Email

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
2016 Year 10 Month 01 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
2016 Year 08 Month 15 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 01 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 09 Month 27 Day
Last modified on
2016 Year 09 Month 27 Day


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


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