Unique ID issued by UMIN | UMIN000023318 |
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Receipt number | R000026866 |
Scientific Title | Exploratory study of clinical effectiveness and safety of daikenchuto (TJ-100) for gastrointestinal symptoms such as abdominal pain and distention following laparoscopic colectomy in colon cancer patients |
Date of disclosure of the study information | 2016/08/01 |
Last modified on | 2019/07/29 12:19:41 |
Exploratory study of clinical effectiveness and safety of daikenchuto (TJ-100) for gastrointestinal symptoms such as abdominal pain and distention following laparoscopic colectomy in colon cancer patients
Exploratory study of clinical effectiveness and safety of daikenchuto (TJ-100) for gastrointestinal symptoms such as abdominal pain and distention following laparoscopic colectomy in colon cancer patients
Exploratory study of clinical effectiveness and safety of daikenchuto (TJ-100) for gastrointestinal symptoms such as abdominal pain and distention following laparoscopic colectomy in colon cancer patients
Exploratory study of clinical effectiveness and safety of daikenchuto (TJ-100) for gastrointestinal symptoms such as abdominal pain and distention following laparoscopic colectomy in colon cancer patients
Japan |
Colon cancer
Gastrointestinal surgery |
Malignancy
NO
To investigate the effect of daikenchuto for ethical use for accompanying abdominal symptoms (abdominal pain and distention, etc ) and QOL after laparoscopic colectomy in the colon cancer patients
Safety,Efficacy
Exploratory
1) Numerical Rating Scale of abdominal pain
2) Numerical Rating Scale of abdominal distention
3) Gastrointestinal Quality of Life Index (GIQLI)
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
2
Treatment
Medicine |
A group: Oral administration of test drug (daikenchuto) 5.0 g per dose as a general rule (15 g/day, t.i.d., before meals) from postoperative day 2 to postoperative day 28.
B group: Non-treatment.
20 | years-old | <= |
Not applicable |
Male and Female
In order to participate in this study, a patient must meet all of the following criteria.
1) Patients who qualify for curative resection for colon cancer.
Preoperative TNM category distribution: T=1a-3, N=0-2,M=0
2) Patients who suffer from abdominal pain and distention on postoperative day 1.
3)PS (ECOG Performance Status Scale): 0-2
4) Age: over 20 yo.
5) Gender: no specification
6) Inpatient/Outpatient: Inpatient
7) Patients who can orally take Daikenchuto
8) Patients who can provide written informed
consent
1) Patients who can orally take Daikenchuto on postoperative day 1.
2) Patients with history of laparotomy
3) Patients with history of ileum.
4) Patients with concomitant inflammatory bowel disease such as ulcerative colitis and crohn disease.
5) Patients with concomitant endometriosis
6) Patients requiring emergency surgery
7) Patients who have been treated or will be treated by chemotherapy or radiotherapy for primary disease
8) Patients with serious concomitant diseases
9) Patients who took prohibited concomitant drugs 4 weeks before treatment.
10) Patients with history of allergy for other Kampo
formulation(s)
11) Patients with infection of HBV or HCV
12) Others, including patients who are unfit for the study as determined by the attending physician
40
1st name | |
Middle name | |
Last name | Yoshiharu Sakai |
Kyoto University
Department of gastrointestinal surgery
54 Shogoin Kawara-cho, Sakyo-ku, Kyoto, 606-8507, JAPAN
075-751-3650
ysakai@kuhp.kyoto-u.ac.jp
1st name | |
Middle name | |
Last name | Department of gastrointestinal surgery, Kyoto University |
Kyoto University
Department of gastrointestinal surgery
54 Shogoin Kawara-cho, Sakyo-ku, Kyoto, 606-8507, JAPAN
075-751-3650
ysakai@kuhp.kyoto-u.ac.jp
Department of gastrointestinal surgery, Kyoto University
Tsumura company
Profit organization
NO
2016 | Year | 08 | Month | 01 | Day |
Unpublished
No longer recruiting
2016 | Year | 04 | Month | 15 | Day |
2016 | Year | 01 | Month | 06 | Day |
2016 | Year | 08 | Month | 01 | Day |
2019 | Year | 03 | Month | 31 | Day |
2016 | Year | 07 | Month | 25 | Day |
2019 | Year | 07 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026866
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