The investigation for the association between the choleretic effects of Inchinkoto and intestinal microenvironment in patients with obstructive jaundice.

The investigation for the association between the choleretic effects of Inchinkoto and intestinal microenvironment in patients with obstructive jaundice. - The investigation for the association between the choleretic effects of Inchinkoto and intestinal microenvironment in patients with obstructive jaundice.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000025200

Enrollment

Registered

2016-12-17

Start date

2017-04-01

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

Patients with external biliary drainage due to obstructive jaundice.

Interventions

TJ-135 TSUMURA Inchinkoto Extract Granules for Ethical Use. Oral administration of Hangeshashinto (7.5g/day t.i.d. before meals) for 3 days.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients with biliary stenosis. 2)Patients with biliary drainage by percutaneous transhepatic biliary drainage or endoscopic nasal biliary drainage. At least 3 days after biliary drainage. 3)Age over 20 years. 4)Inhospital patients. 5)Patients who can do oral intake. 6)Patients who agree to participate in this study.

Exclusion criteria

Exclusion criteria: 1)Patients with severe complications such as renal, cardiac, hematologic, and metabolic diseases. 2)Patients who are taking "Kampo" within 4 weeks. 3)Patients who are taking choleretic drug within 4 weeks. 4)Patients in pregnant or who expect being pregnant. 5)Patients who are allergic to "Kampo". 6)Patients who are not eligible for this study by investigators' decision.

Design outcomes

Primary

Measure	Time frame
1) Choleretic effect of Inchinkoto; Alterations of biliary concentrations of bile acid, total bilirubin, and direct bilirubin. Alteration of total biliary flow. 2) Association between choleretic effect of Inchinkoto and intestinal microenvironment. Investigate the association between the choleretic effect of Inchinkoto and intestinal microflora, fecal metabolome, fecal organic acids, and fecal pH.	—

Measure

Time frame

1) Choleretic effect of Inchinkoto; Alterations of biliary concentrations of bile acid, total bilirubin, and direct bilirubin. Alteration of total biliary flow. 2) Association between choleretic effect of Inchinkoto and intestinal microenvironment. Investigate the association between the choleretic effect of Inchinkoto and intestinal microflora, fecal metabolome, fecal organic acids, and fecal pH.

—

Secondary

Measure	Time frame
Serum levels of total bilirubin and direct bilirubin.	—

Countries

Japan

Contacts

Public ContactYukihiro Yokoyama

Nagoya University Department of Surgery, Division of Surgical Oncology

yyoko@med.nagoya-u.ac.jp0527442218

Outcome results

None listed

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