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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014326
Receipt No. R000016245
Scientific Title Randomized controlled trial of Japanese herbal medicine, daikenchuto for preventive effects of bowel dysfunction after adult liver transplantation.
Date of disclosure of the study information 2014/07/01
Last modified on 2016/09/29

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Basic information
Public title Randomized controlled trial of Japanese herbal medicine, daikenchuto for preventive effects of bowel dysfunction after adult liver transplantation.
Acronym Randomized controlled trial of Japanese herbal medicine, daikenchuto for preventive effects of bowel dysfunction after adult liver transplantation.(DKB 14 Study)
Scientific Title Randomized controlled trial of Japanese herbal medicine, daikenchuto for preventive effects of bowel dysfunction after adult liver transplantation.
Scientific Title:Acronym Randomized controlled trial of Japanese herbal medicine, daikenchuto for preventive effects of bowel dysfunction after adult liver transplantation.(DKB 14 Study)
Region
Japan

Condition
Condition liver transplant recipient (including organ transplant from a brain-dead donor)
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effect of daikenchuto on the early recovery of the gastrointestinal function after liver transplantation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes 1) intake of total calories in oral or enteral nutrition on postoperative day 7.
2) gastrointestinal symptoms on postoperative day 7. : NRS
Key secondary outcomes 1) intake of total calories in oral or enteral nutrition.
2) gastrointestinal symptoms: NRS
3) recovery of the gastrointestinal function after liver transplantation.(time to the first defecation.)
4) quality of life : GSRS score
5) assessment of liver function
6) rate of liver regeneration
7) rate of the bacteremia after liver transplantation
8) the trough of the immunosuppressive drug
9) acute cellular or humoral rejection.
10) the rate of leaving hospital on postoperative 2 months
11) portal venous blood flow
12) volume of ascites fluid
13) adverse event
14) adverse effect

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 daikenchuto group
5g of daikenchuto was administered orally three times a day from postoperative day 1 to 14.
Interventions/Control_2 placebo group
5g of placebo was administered orally three times a day from postoperative day 1 to 14.
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 needs liver transplant.
2) adult patients who plans to undergo a liver transplant(including organ transplant from a brain-dead donor.)
3) Age >=20 at the time of registration.
4) patients who met the eligibility criteria of the recipient on the medical institution which performs liver transplant.
5) Informed consent on the form filled out by the patient or the legal representative of the person.
Key exclusion criteria 1) patients with uncontrolled active infection , excluding infection in the liver and gall bladder
2) patients with uncontrolled cancer , excluding cancer in the liver
3) patients with the disease that cannot enforce a liver transplant safely
4) patients with the history of mechanical ileus , or assumed the intra-abdominal adhesion after gastrointestinal surgery.
5) patients taking prokinetic agent, antipsychotic drug, antidepressant, herbal medicine
6) females who are in pregnancy or lactation, may be pregnant
7) patients whom were considered inappropriate by the doctors for participation in this study
Target sample size 110

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshimi Kaido
Organization Graduate School of medicine, Kyoto University
Division name Division of Hepato-Biliary-Pancreatic Surgery and Transplantation, Department of Surgery
Zip code
Address 54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto, JAPAN
TEL 075-751-3243
Email kaido@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshimi Kaido
Organization Graduate School of medicine, Kyoto University
Division name Division of Hepato-Biliary-Pancreatic Surgery and Transplantation, Department of Surgery
Zip code
Address 54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto, JAPAN
TEL 075-751-3243
Homepage URL
Email kaido@kuhp.kyoto-u.ac.jp

Sponsor
Institute Division of Hepato-Biliary-Pancreatic Surgery and Transplantation, Department of Surgery, Graduate School of medicine, Kyoto University
Institute
Department

Funding Source
Organization TSUMURA & CO.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 京都大学(京都府)、北海道大学(北海道)、東京大学(東京都)、岡山大学(岡山県)、九州大学(福岡県)、慶応大学(東京都)、東京女子医科大学(東京都)、信州大学(長野県)、名古屋大学(愛知県)、大阪大学(大阪府)、広島大学(広島県)、愛媛大学(愛媛県)、熊本大学(熊本県)、長崎大学(長崎県)

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 01 Day

Related information
URL releasing protocol http://bmjopen.bmj.com/content/5/9/e008356
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 Completed
Date of protocol fixation
2014 Year 07 Month 24 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 01 Day
Last follow-up date
2016 Year 07 Month 31 Day
Date of closure to data entry
2016 Year 08 Month 20 Day
Date trial data considered complete
2016 Year 08 Month 30 Day
Date analysis concluded
2016 Year 09 Month 26 Day

Other
Other related information

Management information
Registered date
2014 Year 06 Month 20 Day
Last modified on
2016 Year 09 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016245

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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