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Randomized controlled trial of Japanese herbal medicine, daikenchuto for preventive effects of bowel dysfunction after adult liver transplantation.

Randomized controlled trial of Japanese herbal medicine, daikenchuto for preventive effects of bowel dysfunction after adult liver transplantation. - Randomized controlled trial of Japanese herbal medicine, daikenchuto for preventive effects of bowel dysfunction after adult liver transplantation.(DKB 14 Study)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000014326
Enrollment
110
Registered
2014-07-01
Start date
2014-08-01
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

liver transplant recipient (including organ transplant from a brain-dead donor)

Interventions

daikenchuto group 5g of daikenchuto was administered orally three times a day from postoperative day 1 to 14. placebo group 5g of placebo was administered orally three times a day from postoperative

Sponsors

Division of Hepato-Biliary-Pancreatic Surgery and Transplantation, Department of Surgery, Graduate School of medicine, Kyoto University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) patients who needs liver transplant. 2) adult patients who plans to undergo a liver transplant(including organ transplant from a brain-dead donor.) 3) Age >=20 at the time of registration. 4) patients who met the eligibility criteria of the recipient on the medical institution which performs liver transplant. 5) Informed consent on the form filled out by the patient or the legal representative of the person.

Exclusion criteria

Exclusion criteria: 1) patients with uncontrolled active infection , excluding infection in the liver and gall bladder 2) patients with uncontrolled cancer , excluding cancer in the liver 3) patients with the disease that cannot enforce a liver transplant safely 4) patients with the history of mechanical ileus , or assumed the intra-abdominal adhesion after gastrointestinal surgery. 5) patients taking prokinetic agent, antipsychotic drug, antidepressant, herbal medicine 6) females who are in pregnancy or lactation, may be pregnant 7) patients whom were considered inappropriate by the doctors for participation in this study

Design outcomes

Primary

MeasureTime frame
1) intake of total calories in oral or enteral nutrition on postoperative day 7. 2) gastrointestinal symptoms on postoperative day 7. : NRS

Secondary

MeasureTime frame
1) intake of total calories in oral or enteral nutrition. 2) gastrointestinal symptoms: NRS 3) recovery of the gastrointestinal function after liver transplantation.(time to the first defecation.) 4) quality of life : GSRS score 5) assessment of liver function 6) rate of liver regeneration 7) rate of the bacteremia after liver transplantation 8) the trough of the immunosuppressive drug 9) acute cellular or humoral rejection. 10) the rate of leaving hospital on postoperative 2 months 11) portal venous blood flow 12) volume of ascites fluid 13) adverse event 14) adverse effect

Countries

Japan

Contacts

Public ContactToshimi Kaido

Graduate School of medicine, Kyoto University Division of Hepato-Biliary-Pancreatic Surgery and Transplantation, Department of Surgery

kaido@kuhp.kyoto-u.ac.jp075-751-3243

Outcome results

None listed

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