UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation for the effects of hydrogen rich water on chronic hepatitis and liver cirrhosis
Title of the study (Brief title)	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	Akinobu Takaki
Organization	Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences.
Division name	Department of Gastroenterology and Hepatology
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	Akinobu Takaki
Organization	Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences.
Division name	Department of Gastroenterology and Hepatology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 01 Month 29 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000011383