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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Ulcerative colitis | |
Classification by specialty |
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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 |
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Interventions/Control_1 | hydrogen gas
8 weeks inhalation the inhalation for 4 hours per day 12 weeks observation after the inhalation |
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Interventions/Control_2 | placebo gas
8 weeks inhalation the inhalation for 4 hours per day 12 weeks observation after the inhalation |
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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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Ulcerative colitis
eMayo score1, Mayo score3~10 |
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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. |
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Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Juntendo University Hospital | ||||||
Division name | Gastroenterology | ||||||
Zip code | 1138431 | ||||||
Address | 3-1-1 Hongo Bunkyo-ku Tokyo Japan | ||||||
TEL | 0338133111 | ||||||
dai@juntendo.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Juntendo University Hospital | ||||||
Division name | Gastroenterology | ||||||
Zip code | 1138431 | ||||||
Address | 3-1-1 Hongo Bunkyo-ku Tokyo Japan | ||||||
TEL | 0338133111 | ||||||
Homepage URL | |||||||
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |