Effect of Rikkunshito on achievement of enteral nutritional goal in critically ill patients: a pilot randomized controlled trial

Effect of Rikkunshito on achievement of enteral nutritional goal in critically ill patients: a pilot randomized controlled trial - Effect of Rikkunshito on enteral nutrition in critically ill patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000031466

Enrollment

Registered

2018-03-01

Start date

2018-03-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critically ill patients requiring enteral nutrition longer than five days

Interventions

2.5 g of Rikkunshito is given three times daily enterally for 5 days 5 g of Rikkunshito is given three times daily enterally for 5 days Control. Rikkunshito is not given.

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The rate of achievement of enteral nutritional goal at fifth day (Actual calories of enteral nutrition divided by the goal of enteral nutrition)	—

Secondary

Measure	Time frame
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)	—

Countries

Japan

Contacts

Public ContactKyohei Miyamoto Kyohei Miyamoto

Wakayama Medical University Department of Emergency and Critical Care Medicine

gomadofu@wakayama-med.ac.jp073-441-0603

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026