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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025200
Receipt No. 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 2016/12/20

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

Public contact
Name of contact person
1st name
Middle name
Last name Yokoyama Yukihiro
Organization Nagoya University Graduate School of Medicine
Division name Department of Surgery, Division of Surgical Oncology
Zip code
Address 65 Tsurumai-cho, Showa-ku, Aichi, Japan
TEL 052-744-2222
Homepage URL
Email yyoko@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Hospital
Institute
Department

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
Address
Tel
Email

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
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 Preinitiation
Date of protocol fixation
2016 Year 12 Month 08 Day
Date of IRB
Anticipated trial start date
2017 Year 04 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

Management information
Registered date
2016 Year 12 Month 09 Day
Last modified on
2016 Year 12 Month 20 Day


Link to view the page
URL(English) https://upload.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


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