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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000010693
Receipt No. R000011383
Scientific Title Investigation for the effects of hydrogen rich water on chronic hepatitis and liver cirrhosis
Date of disclosure of the study information 2013/05/20
Last modified on 2017/05/14

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Basic information
Public title Investigation for the effects of hydrogen rich water on chronic hepatitis and liver cirrhosis
Acronym Hydrogen rich water for chronic hepatitis
Scientific Title Investigation for the effects of hydrogen rich water on chronic hepatitis and liver cirrhosis
Scientific Title:Acronym Hydrogen rich water for chronic hepatitis
Region
Japan

Condition
Condition Chronic hepatitis and liver cirrhosis
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether hydrogen rich water reduces oxidative stress and elevated ALT levels.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Reduction of high ALT
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 GroupA:drink hydrogen rich water 1L/day for 1month, following 1month washout and drink control water 1L/day for 1month.
Interventions/Control_2 GroupB:drink control water 1L/day for 1month, following 1 month washout and drink hydrogen rich water 1L/day for a month.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1)chronic hepatitis or liver cirrhosis diagnosed with liver biopsy or radiography and show ALT elevation with standard therapy.
2)Patients whose ALT levels kept beyond upper limit of normal range for more than 2 months.
Key exclusion criteria 1)Patients who need albumin administration more than once /week for 1 month or more.
2)Patients with edema or ascite.
3)Patients with hepatic encephalopathy.
4)Bilirubin levels equal or >2mg/dl.
5)Albumin levels <3g/dl.
6)Serum Na <130 mEq/L
7)Alcohol abuser.
8)Creatinin equal or >1.3mg/dl.
9)Patients who are receiving interferon treatment.
10)Family Doctors comment
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akinobu Takaki
Organization Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences.
Division name Department of Gastroenterology and Hepatology
Zip code
Address 2-5-1Shikata Cho, Kita-Ku, Okayama City, 700-8558Japan
TEL 086-235-7219
Email akitaka@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akinobu Takaki
Organization Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences.
Division name Department of Gastroenterology and Hepatology
Zip code
Address 2-5-1Shikata Cho, Kita-Ku,Okayama City
TEL 086-235-7219
Homepage URL
Email akitaka@md.okayama-u.ac.jp

Sponsor
Institute Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences.Department of Gastroenterology and Hepatology
Institute
Department

Funding Source
Organization Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences.Department of Gastroenterology and Hepatology
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2013 Year 05 Month 20 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 Terminated
Date of protocol fixation
2013 Year 01 Month 29 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 01 Day
Last follow-up date
2017 Year 12 Month 31 Day
Date of closure to data entry
2018 Year 03 Month 31 Day
Date trial data considered complete
2018 Year 03 Month 31 Day
Date analysis concluded
2018 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2013 Year 05 Month 11 Day
Last modified on
2017 Year 05 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011383

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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