Unique ID issued by UMIN | UMIN000007388 |
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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 |
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 -
Clinical efficacy of Daikenchuto for gastrointestinal symptoms in patients with history of colorectal cancer surgery
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 -
Clinical efficacy of Daikenchuto for gastrointestinal symptoms in patients with history of colorectal cancer surgery
Japan |
Gastrointestinal symptom (disorder of defecation, abdominal bloating) after colorectal cancer surgery
Gastrointestinal surgery |
Others
NO
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
Safety,Efficacy
1)total number of elimination of the radiopaque markers
2) oro-cecal transit time
3) GSRS (Japanese Version) Score
4) VAS
5) GVS
1) segmental transit time(gastric emptying, small intestinal transit, and colonic transit (right, left, and rectosigmoid colon))
2) safety
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
A group: Oral administration of Daikenchuto (15g/day t.i.d. before meals) for 28 days. Thereafter non-treatment for 28 days.
B group: Non-treatment for 28 days. Thereafter oral administration of Daikenchuto (15g/day t.i.d. before meals) for 28 days.
20 | years-old | <= |
Not applicable |
Male and Female
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
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
30
1st name | |
Middle name | |
Last name | Ohdan, Hideki |
Hiroshima University Hospital
Gastrointestinal Surgery
1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
0822575222
hohdan@hiroshima-u.ac.jp
1st name | |
Middle name | |
Last name | Haruki Sada |
Graduate school of biomedical sciences, Hiroshima university
Department of surgery, division of frontier medical science, programs for biomedical research
1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
0822575222
z011028sangyo@yahoo.co.jp
Department of surgery, division of frontier medical science, programs for biomedical research, Graduate school of biomedical sciences, Hiroshima university
Department of surgery, division of frontier medical science, programs for biomedical research, Graduate school of biomedical sciences, Hiroshima university
Self funding
NO
2012 | Year | 04 | Month | 01 | Day |
Unpublished
Completed
2011 | Year | 12 | Month | 01 | Day |
2011 | Year | 12 | Month | 01 | Day |
2015 | Year | 03 | Month | 01 | Day |
2015 | Year | 03 | Month | 01 | Day |
2015 | Year | 03 | Month | 01 | Day |
2016 | Year | 03 | Month | 01 | Day |
2012 | Year | 02 | Month | 27 | Day |
2018 | Year | 06 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007626
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