UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016750 |
|---|---|
| Receipt number | 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 09:40:28 |
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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
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
isao-h@yamaguchi-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019439
