UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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 -
Title of the study (Brief title)	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	Ohdan, Hideki
Organization	Hiroshima University Hospital
Division name	Gastrointestinal Surgery
Address	1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
TEL	0822575222
Email	hohdan@hiroshima-u.ac.jp

Public contact
Name of contact person	Haruki Sada
Organization	Graduate school of biomedical sciences, Hiroshima university
Division name	Department of surgery, division of frontier medical science, programs for biomedical research
Address	1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
TEL	0822575222
Homepage URL
Email	z011028sangyo@yahoo.co.jp

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

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 12 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007626