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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016750
Receipt No. R000019439
Scientific Title The beneficial effect of branched-chain amino acids for patients with HCV related chronic liver disease
Date of disclosure of the study information 2015/03/09
Last modified on 2018/03/20

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Basic information
Public title The beneficial effect of branched-chain amino acids for patients with HCV related chronic liver disease
Acronym The beneficial effect of branched-chain amino acids for patients with HCV related chronic liver disease
Scientific Title The beneficial effect of branched-chain amino acids for patients with HCV related chronic liver disease
Scientific Title:Acronym The beneficial effect of branched-chain amino acids for patients with HCV related chronic liver disease
Region
Japan

Condition
Condition HCV related chronic liver disease
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigate the efficancy of branched-chain amino acid for HCV related chronic liver disease patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 1) Improvement of insulin resistance
2) Reduction of oxidative stress
Key secondary outcomes 1) Change of HCV-RNA
2) Improvement of loss of zinc
3) Improvement of BTR
4) Incidence of HCC
5) Occurrence of side effect

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Patients who obtained the consent, administer the BCAA enriched supplement for 12 weeks in addition to the original treatment. containing
Interventions/Control_2
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 1) Age, over 20 years old
2) Male and female
3) Patients who has inslin resistance
4) Patients who has no HCC
5) Patients who obtained the consent
Key exclusion criteria 1) Cirrotic patients with BCAA formulation while taking
2) Patients during interferon therapy in chronic hepatitis C, cirrhosis
3) Patients receiving medication for diabetes
4) Patients in the intake of dietary supplements containing the BCAA and zinc
5) Patients for branched-chain amino acids and zinc formulation, with a history of hypersensitivity
6) Pregnant woman and women who may possibly be pregnant, women in nursing
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Isao Hidaka
Organization Yamaguchi Univercity Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 1-1-1 Minamikogushi, Uba, Yamaguchi
TEL 0836-22-2241
Email isao-h@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Isao Hidaka
Organization Yamaguchi Univercity Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 1-1-1 Minamikogushi, Uba, Yamaguchi
TEL 0836-22-2241
Homepage URL
Email isao-h@yamaguchi-u.ac.jp

Sponsor
Institute Department of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine
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 山口大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2015 Year 03 Month 09 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 Completed
Date of protocol fixation
2014 Year 07 Month 10 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 01 Day
Last follow-up date
2015 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
2015 Year 03 Month 31 Day
Date analysis concluded
2015 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 03 Month 09 Day
Last modified on
2018 Year 03 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019439

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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