UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014326 |
|---|---|
| Receipt number | 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 08:45:02 |
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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
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
kaido@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Division of Hepato-Biliary-Pancreatic Surgery and Transplantation, Department of Surgery, Graduate School of medicine, Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016245
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