UMIN-CTR Clinical Trial

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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