UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized controlled trial of Japanese herbal medicine, daikenchuto for preventive effects of bowel dysfunction after adult liver transplantation.
Title of the study (Brief title)	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	Toshimi Kaido
Organization	Graduate School of medicine, Kyoto University
Division name	Division of Hepato-Biliary-Pancreatic Surgery and Transplantation, Department of Surgery
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	Toshimi Kaido
Organization	Graduate School of medicine, Kyoto University
Division name	Division of Hepato-Biliary-Pancreatic Surgery and Transplantation, Department of Surgery
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 24 Day
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

Related information
URL releasing protocol	http://bmjopen.bmj.com/content/5/9/e008356
Publication of results	Unpublished
URL releasing results
Results
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