Association between the choleretic effects of Inchinkoto and intestinal microenvironment

JRCT ID: jRCTs041180158

Registered date:29/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Patients with external biliary drainage due to obstructive jaundice.
• Date of first enrollment: 20/05/2017
• Target sample size: 55
• Study type: Interventional
• Intervention(s): TJ-135 TSUMURA Inchinkoto Extract Granules for Ethical Use. Oral administration of Inchinkoto (7.5g/day t.i.d. before meals) for 3 days.

Outcome(s)

Primary Outcome

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 Outcome: Serum levels of total bilirubin and direct bilirubin.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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 who are participating or scheduled to participate in another trial.
5)Patients in pregnant or who expect being pregnant.
6)Patients who are allergic to "Kampo".
7)Patients who are not eligible for this study by investigators' decision.

Related Information

• Primary Sponsor: Yokoyama Yukihiro
• Source(s) of Monetary Support: TSUMURA & CO.
• Secondary ID(s): UMIN000025200