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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033110
Receipt No. R000037758
Official scientific title of the study Open labeled examination to observe the effects of the hydrogen bath for arms containing 1.6ppm molecular hydrogen on the pain and/or swelling of the hands and arms.
Date of disclosure of the study information 2018/06/29
Last modified on 2018/06/25

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Basic information
Official scientific title of the study Open labeled examination to observe the effects of the hydrogen bath for arms containing 1.6ppm molecular hydrogen on the pain and/or swelling of the hands and arms.
Title of the study (Brief title) Open labeled examination to observe the effects of the hydrogen bath for arms containing 1.6ppm molecular hydrogen on the pain and/or swelling of the hands and arms.
Region
Japan

Condition
Condition patients with the pain and/or swelling in their hands or arms
Classification by specialty
Clinical immunology Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to improve of the pain or swelling
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes improvements of the pain or swelling
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 Treatment
Type of intervention
Other
Interventions/Control_1 Soaking the hands and arms in the hydrogen bath supplied with the fresh water containing 1.6 ppm hydrogen for 30 min or 1 hour.
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

Not applicable
Gender Male and Female
Key inclusion criteria Outpatients who have the pain and/or swelling in their hands or arms.
Key exclusion criteria All of the subjects do not have any infection and skin diseases.
Target sample size 50

Research contact person
Name of lead principal investigator Toru Ishibashi
Organization Huis Ten Bosch Satellite H2 Clinic Hakata
Division name Department of rheumatology
Address 2-1 Gion, Hakata-ku, Fukuoka 812-0038, Japan
TEL +81-92-282-5005
Email tishibashi@h2-lab.jp

Public contact
Name of contact person Toru Ishibashi
Organization Huis Ten Bosch Satellite H2 Clinic Hakata
Division name Department of rheumatology
Address 2-1 Gion, Hakata-ku, Fukuoka 812-0038, Japan
TEL +81-92-282-5005
Homepage URL
Email info@h2-clinic.jp

Sponsor
Institute Huis Ten Bosch Satellite H2 Clinic Hakata
Ecomo International Co., Ltd.
Institute
Department

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)

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 06 Month 29 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2015 Year 11 Month 21 Day
Anticipated trial start date
2015 Year 12 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 06 Month 22 Day
Last modified on
2018 Year 06 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037758

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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