UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012186 |
|---|---|
| Receipt number | R000014247 |
| Scientific Title | The effect of nutrition-supplement drink for post-operative cardiac rehabilitation |
| Date of disclosure of the study information | 2013/11/01 |
| Last modified on | 2024/05/09 16:48:48 |
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Basic information
Public title
The effect of nutrition-supplement drink for post-operative cardiac rehabilitation
Acronym
The effect of nutrition-supplement drink
Scientific Title
The effect of nutrition-supplement drink for post-operative cardiac rehabilitation
Scientific Title:Acronym
The effect of nutrition-supplement drink
Region
| Japan |
Condition
Condition
post-CABG surgery
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine progressing effect of the cardiac rehabilitation or anti-inflammatory effect of the by taking nutrition-supplement drink
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
daily amount of activity in post-operative period
Key secondary outcomes
serum inflammation marker
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
nutrition-supplement drink
Interventions/Control_2
normal treatment
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
Patients underwent CABG surgery who can walk pre-surgery
Key exclusion criteria
renal failure (eGFR <15mL/min/1.73mm2)
hemodialysis
liver dysfunction (any abnormal value in following marker: AST, ALT, or gamma-GTP)
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Matsushita |
Organization
Juntendo University
Division name
Department of Cardiovascular Surgery
Zip code
1138421
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
saty-m@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Matsushita |
Organization
Juntendo University
Division name
Department of Cardiovascular Surgery
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
saty-m@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University, Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Sato Pharmaceutical Co Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University Facutly of Medicine
Address
Hongo 2-1-1 Bunkyo-ku, Tokyo
Tel
0338133111
saty-m@juntendo.ac.jp
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 | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2013 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 31 | Day |
Last modified on
| 2024 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014247
