UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Metabolome analysis in association with the effects of Inchinkoto, a herbal medicine.
Title of the study (Brief title)	Metabolome analysis in association with the effects of Inchinkoto.
Region	Japan

Condition
Condition	The patients who undergo percutaneous transhepatic biliary drainage (PTBD) or endoscopic nasobiliary drainage (ENBD) due to biliary obstruction. Among the, patients who were included the study "The association between the intestinal microenvironment and choleretic effects of Inchinkoto. (UMIN 000013250) with blood and bile sampling.
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To perform metabolomic analysis in patients who took Inchinkoto, a traditional herbal medicine.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Alternation of metabolome after an oral intake of Inchinkoto.
Key secondary outcomes	The association between the serum concentrations of genipin, geniposide, and 6,7-dimetylesculetin and the biliary concentrations of total bilirubin, direct bilirubin, and bile acid.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Patients who undergo transhepatic biliary drainage (PTBD) or endoscopic nasobiliary drainage (ENBD) due to obstructive jaundice. 2. Patients who agree to participate this study. Note; patients who are undergoing antibiotics therapy such as Chloramphenicol will not be excluded.
Key exclusion criteria	1. Patients who do not agree to participate this study. 2. Patients who are not eligible to participate this study (determined by chief or associate doctors who are responsible to perform this study. 3. Patients who are allergic to Inchinkoto. 4. Patients who are taking choleretic drugs such as ulsodeoxycholic acid.
Target sample size	46

Research contact person
Name of lead principal investigator	masato nagino
Organization	Nagoya University Graduate School of Medicine
Division name	Division of Surgical Oncology, Department of Surgery,
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL	+81527442222
Email	nagino@med.nagoya-u.ac.jp

Public contact
Name of contact person	yukihiro yokoyama
Organization	Nagoya University Hospital
Division name	Surgery 1
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL	+81527442222
Homepage URL
Email	yyoko@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Not applicable
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	名古屋大学医学部附属病院（愛知県）

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 01 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 12 Month 18 Day
Anticipated trial start date	2016 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	The aim of this study was to perform metabolomic analysis in the blood and bile samples, which were collected in a clinical study "The study for the effects of intestinal microenvironment on the choleretic effect of Inchinkoto, a herbal medicine (UMIN 000013250)."

Management information
Registered date	2015 Year 12 Month 18 Day
Last modified on	2018 Year 12 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023396