UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031466 |
|---|---|
| Receipt number | R000035918 |
| Scientific Title | Effect of Rikkunshito on achievement of enteral nutritional goal in critically ill patients: a pilot randomized controlled trial |
| Date of disclosure of the study information | 2018/03/01 |
| Last modified on | 2019/07/10 12:18:04 |
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Basic information
Public title
Effect of Rikkunshito on achievement of enteral nutritional goal in critically ill patients: a pilot randomized controlled trial
Acronym
Effect of Rikkunshito on enteral nutrition in critically ill patients
Scientific Title
Effect of Rikkunshito on achievement of enteral nutritional goal in critically ill patients: a pilot randomized controlled trial
Scientific Title:Acronym
Effect of Rikkunshito on enteral nutrition in critically ill patients
Region
| Japan |
Condition
Condition
Critically ill patients requiring enteral nutrition longer than five days
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of different doses of Rikkunshito on achievement of enteral nutrition goal and ghrelin concentration.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
The rate of achievement of enteral nutritional goal
at fifth day (Actual calories of enteral nutrition divided by the goal of enteral nutrition)
Key secondary outcomes
1. Plasma ghrelin concentration (before breakfast at
day1, 3, 5)
2. Dose of drainage from gastric tube
3. Prescribed calories by parenteral route during five days
4. Length of intensive care unit stay
5. Length of hospital stay
6. Hospital mortality
7. Adverse event (hypokalemia, elevation of creatinine kinase, elevation of transaminase, skin rash)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
2.5 g of Rikkunshito is given three times daily enterally for 5 days
Interventions/Control_2
5 g of Rikkunshito is given three times daily enterally for 5 days
Interventions/Control_3
Control. Rikkunshito is not given.
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
Adult ICU patients (>=20 years old) are eligible if they are started enteral nutrition within 48 hours from admission, and they are estimated to need enteral nutrition longer than five days.
Key exclusion criteria
1. Extremely severe patients who are estimated to die within 48 hours
2. Patients who have do-not-resuscitate order.
3. Allergy for Rikkunshito, sojutsu, taiso, ninjin, hange, kanzo, bukuryo, or syokyo.
4. Patients who have anatomical abnormality in esophagus or smomach (e.g. after the total gastrectomy)
5. Pregnant or lactating women
6. Attending physicians' decision
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Kyohei Miyamoto |
| Middle name | |
| Last name | Kyohei Miyamoto |
Organization
Wakayama Medical University
Division name
Department of Emergency and Critical Care Medicine
Zip code
6410012
Address
811-1 Kimiidera, Wakayama-City, Wakayama, 641-8509, JAPAN
TEL
073-441-0603
gomadofu@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Kyohei Miyamoto |
| Middle name | |
| Last name | Kyohei Miyamoto |
Organization
Wakayama Medical University
Division name
Department of Emergency and Critical Care Medicine
Zip code
6410012
Address
811-1 Kimiidera, Wakayama-City, Wakayama, 641-8509, JAPAN
TEL
073-441-0603
Homepage URL
gomadofu@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University
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
IRB of WMU
Address
811-1 Kimiidera, Wakayama-City, Wakayama, 641-8509, JAPAN
Tel
073-441-0603
gomadofu@wakayama-med.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
| 2018 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/full/10.1002/ams2.442
Number of participants that the trial has enrolled
26
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
| 2018 | Year | 02 | Month | 25 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 02 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 25 | Day |
Last modified on
| 2019 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035918
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
