UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013250 |
|---|---|
| Receipt number | 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 14:38:10 |
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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
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
yyoko@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015453
