UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005274 |
|---|---|
| Receipt number | 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 07:27:29 |
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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
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
hisashi7@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University East Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006115
