UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000013250
Receipt No. R000015453
Scientific Title The association between the intestinal microenvironment and choleretic effects of Inchinkoto.
Date of disclosure of the study information 2014/04/01
Last modified on 2020/02/29 (Ver. 7)

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Basic information
Public title The association between the intestinal microenvironment and choleretic effects of Inchinkoto.
Acronym The association between the intestinal microenvironment and choleretic effects of Inchinkoto.
Scientific Title The association between the intestinal microenvironment and choleretic effects of Inchinkoto.
Scientific Title:Acronym The association between the intestinal microenvironment and choleretic 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.
Classification by specialty
Hepato-biliary-pancreatic surgery Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine the association between the intestinal microenvironment and choleretic effects of Inchinkoto, especially focusing ont he geniposide metabolism.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The association between the total bilirubin, direct bilirubin, and bile acid levels in the bile (before and after Inchinkoto administration) and the bacterial concentration, bacterial constitute, fecal organic acid concentration, and pH.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 oral intake of Inchinkoto
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) Age >=20
2) The patients who undergo percutaneous biliary drainage (PTBD) or endoscopic nasobiliary drainage (ENBD) due to biliary obstruction.
3) The patients who have agreed to participate in the study.
Key exclusion criteria 1) The patients who have rejected to participate in the study.
2) The patients who have been considered to be not eligible for this study by the investigators.
3)The patients who are having other choleretic drugs such as ursodeoxycholic acid.
Target sample size 25

Research contact person
Name of lead principal investigator
1st name Masato
Middle name
Last name Nagino
Organization Nagoya University Graduate School of Medicine
Division name Department of Surgery, Division of Surgical Oncology
Zip code 4668550
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL 052-744-2222
Email nagino@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Yukihiro
Middle name
Last name Yokoyama
Organization Nagoya University Hospital
Division name First department of surgery
Zip code 4668550
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL 052-744-2222
Homepage URL
Email yyoko@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Hospital
Institute
Department

Funding Source
Organization Nagoya University Graduate School of Medicine, Department of Surgery, Division of Surgical Oncology
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Nagoya University Ethics Committee
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
Tel +81-52-744-2479
Email ethics@med.nagoya-u.ac.jp

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

Other administrative information
Date of disclosure of the study information
2014 Year 04 Month 01 Day

Related information
URL releasing protocol not applicable
Publication of results Published

Result
URL related to results and publications not applicable
Number of participants that the trial has enrolled 45
Results 
There was some association between the choleretic effects of ICKT and intestinal microenvironment profile.
Results date posted
2020 Year 02 Month 29 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
Patients who need to undergo external biliary drainage due to obstructive jaundice.
Participant flow 
After the informed consent, patients were administered ICKT. Before and after the ICKT administration, bile samples were collected. Fecal samples were also collected during the study period.
Adverse events 
None
Outcome measures 
The association between the choleretic effects of ICKT and intestinal microenvironment profile.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2014 Year 02 Month 23 Day
Date of IRB
2014 Year 05 Month 14 Day
Anticipated trial start date
2014 Year 05 Month 14 Day
Last follow-up date
2017 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 02 Month 24 Day
Last modified on
2020 Year 02 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015453