UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020274 |
|---|---|
| Receipt number | R000023396 |
| Scientific Title | Metabolome analysis in association with the effects of Inchinkoto, a herbal medicine. |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2018/12/20 10:35:59 |
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Basic information
Public title
Metabolome analysis in association with the effects of Inchinkoto, a herbal medicine.
Acronym
Metabolome analysis in association with the effects of Inchinkoto.
Scientific Title
Metabolome analysis in association with the effects of Inchinkoto, a herbal medicine.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | masato nagino |
Organization
Nagoya University Graduate School of Medicine
Division name
Division of Surgical Oncology, Department of Surgery,
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
+81527442222
nagino@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | yukihiro yokoyama |
Organization
Nagoya University Hospital
Division name
Surgery 1
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
+81527442222
Homepage URL
yyoko@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2015 | Year | 12 | Month | 18 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023396
