UMIN-CTR Clinical Trial

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