Association between the choleretic effects of Inchinkoto and intestinal microenvironment

Phase 4

Completed

• Conditions: Patients with external biliary drainage due to obstructive jaundice.

• Registration Number: JPRN-jRCTs041180158
• Lead Sponsor: Yokoyama Yukihiro

Brief Summary

sing metabolome analysis, we demonstrated several metabolic changes, such as serum aspartic acid level, that may be associated with the pharmacological mechanisms of ICKT. We also demonstrated the shape of gut microbiome before treatment might be associated with the activity and the efficacy of ICKT.

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-01-02
• Study Start: 2019-03-29
• Results First Posted: 2021-11-17
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 54

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified