UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluating artificial carbonated shower for dermal pruritus in dialysis patients
Title of the study (Brief title)	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	tetsuya yamada
Organization	Kaikoukai Medical Foundation
Division name	Department of Dialysis Department,
Address	1-161 Hokke,Nakagawa,Nagoya City
TEL	052-363-7211
Email	tyamada@touseki.jp

Public contact
Name of contact person	Yoshifumi Moriyama
Organization	Kaikoukai Medical Foundation
Division name	Nagoya Kyoritsu Hospital
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 08 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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