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

Yokoyama Yukihiro0 sites54 target enrollmentMarch 29, 2019

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Not specified
Sponsor: Yokoyama Yukihiro
Enrollment: 54
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

who.int

Start Date

March 29, 2019

End Date

January 2, 2019

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Yokoyama Yukihiro

Eligibility 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

•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.