UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of carbon dioxide enriched water for atopic dermatitis patients
Title of the study (Brief title)	Effect of carbon dioxide enriched water for atopic dermatitis patients
Region	Japan

Condition
Condition	atopic dermatitis patients
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Verify the effect of carbonated spring on atopic dermatitis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	visual analogue scale
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Once a day for 5 minutes 28 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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Patient with atopic dermatitis
Key exclusion criteria	serious complications Pregnant patient Patient judged inappropriate by doctor
Target sample size	30

Research contact person
Name of lead principal investigator	Hori Hiroshi
Organization	nagoya kyoritsu hospital
Division name	Director of a hospital
Address	1-172,Hokke,Nakagawaku,Nagoyashi,Aichi
TEL	0523625151
Email	ymoriyama@kaikou.or.jp

Public contact
Name of contact person	Moriyama Yoshifumi
Organization	nagoya kyoritsu hospital
Division name	rehabilitation Department
Address	1-172,Hokke,Nakagawa-ku,Nagoya-shi,Aichi
TEL	0523625151
Homepage URL
Email	ymoriyama@kaikou.or.jp

Sponsor
Institute	nagoya kyoritsu hospital
Institute
Department

Funding Source
Organization	nagoya kyoritsu hospital
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	2018 Year 09 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 07 Month 01 Day
Anticipated trial start date	2018 Year 07 Month 01 Day
Last follow-up date
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	2018 Year 08 Month 03 Day
Last modified on	2018 Year 08 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038338