UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003569 |
|---|---|
| Receipt number | R000004327 |
| Scientific Title | The effects of Rikkunshito for the early enteral feeding in the critically ill patients. |
| Date of disclosure of the study information | 2010/05/06 |
| Last modified on | 2012/05/11 05:04:51 |
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Basic information
Public title
The effects of Rikkunshito for the early enteral feeding in the critically ill patients.
Acronym
The effects of Rikkunshito for the early enteral feeding in the critically ill patients.
Scientific Title
The effects of Rikkunshito for the early enteral feeding in the critically ill patients.
Scientific Title:Acronym
The effects of Rikkunshito for the early enteral feeding in the critically ill patients.
Region
| Japan |
Condition
Condition
critically ill patients
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of Rikkunshito and metoclopramide in the treatment of feed intolerance in critically ill patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
when is the basal energy expenditure feeded fully?
How many patients is the basal energy expenditure feeded fully?
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Rikkunshito administration
Interventions/Control_2
Metoclopamide administration.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
critically ill patients to start in the enteral feeding
Key exclusion criteria
Patients had complications by Rikkunshito or metoclopramide.
Patients suspected to have chromaffinoma.
Patients administrated arleady Rikkunshito or metoclopramide.
Patients had gastrectomy
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hayakawa Mineji |
Organization
Hokkaido University Hospital
Division name
Emergency and Critical Care Center
Zip code
Address
Kita-ku N14W5, Sapporo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Hokkaido University Hospital
Division name
Emergency and Critical Care Center
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Hokkaido University Hospital
Emergency and Critical Care Center
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University Hospital
Emergency and Critical Care Center
Organization
Division
Category of Funding Organization
Other
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
| 2010 | Year | 05 | Month | 06 | 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
| 2010 | Year | 02 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | Month | 06 | Day |
Last modified on
| 2012 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004327
