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Recruitment status Completed
Unique ID issued by UMIN UMIN000031466
Receipt No. 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

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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
Email 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
Email gomadofu@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035918

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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