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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042017
Receipt No. R000047956
Scientific Title Hydrogen gas inhalation randomized double blinded trial for ulcerative colitis
Date of disclosure of the study information 2020/10/05
Last modified on 2020/10/05

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Basic information
Public title Hydrogen gas inhalation randomized double blinded trial for ulcerative colitis
Acronym Hydrogen gas inhalation randomized double blinded trial for ulcerative colitis
Scientific Title Hydrogen gas inhalation randomized double blinded trial for ulcerative colitis
Scientific Title:Acronym Hydrogen gas inhalation randomized double blinded trial for ulcerative colitis
Region
Japan

Condition
Condition Ulcerative colitis
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The effectiveness of hydrogen gas for the patients with ulcerative colitis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The change of endoscopic findings and symptoms from the baseline to 8th week between hydrogen gas and placebo gas
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 hydrogen gas
8 weeks inhalation
the inhalation for 4 hours per day
12 weeks observation after the inhalation
Interventions/Control_2 placebo gas
8 weeks inhalation
the inhalation for 4 hours per day
12 weeks observation after the inhalation
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 Ulcerative colitis
eMayo score1, Mayo score3~10
Key exclusion criteria All cases with liver disease, kidney disease, heart disease, or other serious complications.
Lactating women, pregnant women, and all cases of possible pregnancy.
Patients with respiratory diseases such as chronic obstructive respiratory disease and asthma.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Dai
Middle name
Last name Ishikawa
Organization Juntendo University Hospital
Division name Gastroenterology
Zip code 1138431
Address 3-1-1 Hongo Bunkyo-ku Tokyo Japan
TEL 0338133111
Email dai@juntendo.ac.jp

Public contact
Name of contact person
1st name Dai
Middle name
Last name Ishikawa
Organization Juntendo University Hospital
Division name Gastroenterology
Zip code 1138431
Address 3-1-1 Hongo Bunkyo-ku Tokyo Japan
TEL 0338133111
Homepage URL
Email dai@juntendo.ac.jp

Sponsor
Institute Juntendo University Hospital
Institute
Department

Funding Source
Organization Miz company
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 Ethics Committee of Juntendo University Hospital
Address 2-1-1 Hongo Bunkyo-ku Tokyo Japan
Tel 0338145672
Email kenkyu5858@juntendo.ac.jp

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
2020 Year 10 Month 05 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 Open public recruiting
Date of protocol fixation
2020 Year 08 Month 13 Day
Date of IRB
2020 Year 08 Month 13 Day
Anticipated trial start date
2020 Year 08 Month 13 Day
Last follow-up date
2022 Year 08 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
2020 Year 10 Month 05 Day
Last modified on
2020 Year 10 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047956

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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