UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007388
Receipt number R000007626
Scientific Title Clinical efficacy of Daikenchuto (DKT: TJ-100) for gastrointestinal symptoms in patients with history of colorectal cancer surgery; crossover study - Gastrointestinal transit time as an indicator -
Date of disclosure of the study information 2012/04/01
Last modified on 2018/06/13 16:40:07

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Clinical efficacy of Daikenchuto (DKT: TJ-100) for gastrointestinal symptoms in patients with history of colorectal cancer surgery; crossover study - Gastrointestinal transit time as an indicator -

Acronym

Clinical efficacy of Daikenchuto for gastrointestinal symptoms in patients with history of colorectal cancer surgery

Scientific Title

Clinical efficacy of Daikenchuto (DKT: TJ-100) for gastrointestinal symptoms in patients with history of colorectal cancer surgery; crossover study - Gastrointestinal transit time as an indicator -

Scientific Title:Acronym

Clinical efficacy of Daikenchuto for gastrointestinal symptoms in patients with history of colorectal cancer surgery

Region

Japan


Condition

Condition

Gastrointestinal symptom (disorder of defecation, abdominal bloating) after colorectal cancer surgery

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effect of TJ-100 Tsumura Daikenchuto extract granules for ethical use for accompanying gastrointestinal symptoms (disorder of defecation, abdominal bloating) and QOL in intestinal dysmotility after colorectal cancer surgery by crossover trial

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1)total number of elimination of the radiopaque markers
2) oro-cecal transit time
3) GSRS (Japanese Version) Score
4) VAS
5) GVS

Key secondary outcomes

1) segmental transit time(gastric emptying, small intestinal transit, and colonic transit (right, left, and rectosigmoid colon))
2) safety


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

A group: Oral administration of Daikenchuto (15g/day t.i.d. before meals) for 28 days. Thereafter non-treatment for 28 days.

Interventions/Control_2

B group: Non-treatment for 28 days. Thereafter oral administration of Daikenchuto (15g/day t.i.d. before meals) for 28 days.

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 history of colorectal cancer surgery before 6 months or more
2) Patients who diagnosed having digestive symptoms (disorder of defecation, abdominal bloating) and required medical treatment as a result of medical examination
3) Relapse-free patients
4) Patients who can orally administration of Daikenchuto
5) Age: over 20 yo.
6) Gender: no specification
7) Outpatient
8) Patients who can provide written informed consent

Key exclusion criteria

1) Patients who have treated by chemotherapy or radiotherapy for primary disease
2) Patients with concomitant inflammatory bowel disease (ulcerative colitis, Crohn's disease)
3) Patients with double cancer (abdominal malignancy)
4) Patients with serious concomitant
5) Patients with serious drug allergy
6) Patients with galactosemia
7) Patients who have taken antibiotics within 4 weeks prior to study examination
8) Patients who are taking other Kampo formulation(s)
9) Patients who are pregnant, possibly pregnant, nursing or considering pregnancy
10) Others, including patients who are unfit for the study as determined by the attending physician

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ohdan, Hideki

Organization

Hiroshima University Hospital

Division name

Gastrointestinal Surgery

Zip code


Address

1-2-3 Kasumi, Minami-ku, Hiroshima, Japan

TEL

0822575222

Email

hohdan@hiroshima-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Haruki Sada

Organization

Graduate school of biomedical sciences, Hiroshima university

Division name

Department of surgery, division of frontier medical science, programs for biomedical research

Zip code


Address

1-2-3 Kasumi, Minami-ku, Hiroshima, Japan

TEL

0822575222

Homepage URL


Email

z011028sangyo@yahoo.co.jp


Sponsor or person

Institute

Department of surgery, division of frontier medical science, programs for biomedical research, Graduate school of biomedical sciences, Hiroshima university

Institute

Department

Personal name



Funding Source

Organization

Department of surgery, division of frontier medical science, programs for biomedical research, Graduate school of biomedical sciences, Hiroshima university

Organization

Division

Category of Funding Organization

Self funding

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

2012 Year 04 Month 01 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

Completed

Date of protocol fixation

2011 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 12 Month 01 Day

Last follow-up date

2015 Year 03 Month 01 Day

Date of closure to data entry

2015 Year 03 Month 01 Day

Date trial data considered complete

2015 Year 03 Month 01 Day

Date analysis concluded

2016 Year 03 Month 01 Day


Other

Other related information



Management information

Registered date

2012 Year 02 Month 27 Day

Last modified on

2018 Year 06 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007626


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name