UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025200 |
|---|---|
| Receipt number | R000028993 |
| Scientific Title | The investigation for the association between the choleretic effects of Inchinkoto and intestinal microenvironment in patients with obstructive jaundice. |
| Date of disclosure of the study information | 2016/12/17 |
| Last modified on | 2021/12/13 08:26:51 |
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Basic information
Public title
The investigation for the association between the choleretic effects of Inchinkoto and intestinal microenvironment in patients with obstructive jaundice.
Acronym
The investigation for the association between the choleretic effects of Inchinkoto and intestinal microenvironment in patients with obstructive jaundice.
Scientific Title
The investigation for the association between the choleretic effects of Inchinkoto and intestinal microenvironment in patients with obstructive jaundice.
Scientific Title:Acronym
The investigation for the association between the choleretic effects of Inchinkoto and intestinal microenvironment in patients with obstructive jaundice.
Region
| Japan |
Condition
Condition
Patients with external biliary drainage due to obstructive jaundice.
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigate the efficacy and safety of Inchinkoto. Clarify the association between the efficacy of Inchinkoto and intestinal microflora, fecal organic acids, fecal pH, and serum levels of Inchinkoto components.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Choleretic effect of Inchinkoto;
Alterations of biliary concentrations of bile acid, total bilirubin, and direct bilirubin.
Alteration of total biliary flow.
2) Association between choleretic effect of Inchinkoto and intestinal microenvironment.
Investigate the association between the choleretic effect of Inchinkoto and intestinal microflora, fecal metabolome, fecal organic acids, and fecal pH.
Key secondary outcomes
Serum levels of total bilirubin and direct bilirubin.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
TJ-135 TSUMURA Inchinkoto Extract Granules for Ethical Use. Oral administration of Hangeshashinto (7.5g/day t.i.d. before meals) for 3 days.
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 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.
Key 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 in pregnant or who expect being pregnant.
5)Patients who are allergic to "Kampo".
6)Patients who are not eligible for this study by investigators' decision.
Target sample size
60
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, Aichi, Japan
TEL
0527442222
yyoko@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukihiro |
| Middle name | |
| Last name | Yokoyama |
Organization
Nagoya University
Division name
Department of Surgery, Division of Surgical Oncology
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Aichi, Japan
TEL
0527442218
Homepage URL
yyoko@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tsumura & Co.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Institutional Review Board
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
Tel
0527442218
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 17 | 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
37
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
Completed
Date of protocol fixation
| 2016 | Year | 12 | Month | 08 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 09 | Day |
Last modified on
| 2021 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028993
| Research Plan | |
|---|---|
| Registered date | File name |
| 2016/12/17 | ICKT new study 研究計画書 final 20161212修.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
