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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005274
Receipt No. R000006115
Scientific Title Efficacy of oral supplementation with branched-chain amino acid granules for quality of life: a randomized controlled trial
Date of disclosure of the study information 2011/03/19
Last modified on 2011/10/11

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Basic information
Public title Efficacy of oral supplementation with branched-chain amino acid granules for quality of life: a randomized controlled trial
Acronym Efficacy of oral supplementation with branched-chain amino acid granules for quality of life: a randomized controlled trial
Scientific Title Efficacy of oral supplementation with branched-chain amino acid granules for quality of life: a randomized controlled trial
Scientific Title:Acronym Efficacy of oral supplementation with branched-chain amino acid granules for quality of life: a randomized controlled trial
Region
Japan

Condition
Condition Decompensate liver cirrhosis
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of study is to investigate the effect of branched-chain amino acid (BCAA) granules for quality of life (QOL) in patients with decompensated liver cirrhosis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Evaluation of QOL by SF-8
Key secondary outcomes Changes of serum albumin concentration

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Three times a day group (one sachet after each meal)
Interventions/Control_2 Twice a day group (one sachet after breakfast, and two sacks before bedtime)
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Decompensate liver cirrhosis with a diagnosis based on histology or unequivocal clinical, sonographic, and laboratory findings.
2 Serum albumin is more than 3.1 g/dl.
Key exclusion criteria Complicated Hepatocellular Carcinoma
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisashi Hidaka
Organization Kitasato University East Hospital
Division name Department of Gastroenterology, Internal Medicine
Zip code
Address 2-1-1 Asamizodai, Minami-ku, Sagamihara, Kanagawa
TEL 042-748-9111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hisashi Hidaka
Organization Kitasato University East Hospital
Division name Department of Gastroenterology, Internal Medicine
Zip code
Address
TEL
Homepage URL
Email hisashi7@kitasato-u.ac.jp

Sponsor
Institute Kitasato University East Hospital
Institute
Department

Funding Source
Organization Nothing
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
2011 Year 03 Month 19 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
2008 Year 10 Month 03 Day
Date of IRB
Anticipated trial start date
2008 Year 11 Month 01 Day
Last follow-up date
2011 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 03 Month 18 Day
Last modified on
2011 Year 10 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006115

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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