Clinical effectiveness of daikenchuto(TJ-100) on gastrointestinal symptoms such as abdominal pain and distention after distal gastrectomy in gastric cancer patients.
- Conditions
- Gastric cancer patients with gastrointestinal symptom (abdominal pain, distention) after distal gastrectomy
- Registration Number
- JPRN-UMIN000006055
- Lead Sponsor
- SHIGA UNIVERSITY OF MEDICAL SCIENCE HOSPITA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Not provided
In order to participate in this study, a patient must not meet any of the following criteria. 1) Patients scheduled to be under postoperative artificial respiration 2) Patients with concomitant or history of inflammatory bowel disease such as ulcerative colitis and Crohn's disease 3) Patients with double cancer 4) Patients with peritoneal metastasis 5) Patients with history of the intestine and colon resections 6) Patient having the dysfunction of the main organ (bone marrrow, heart, liver, kidney, lung and others) 7) Patients with history of laparotomy or peritonitis (excluding surgery for appendicitis) 8) Patients who are administered another Kampo medicines for treatment within 4 weeks before the test drug administration 9) Patients who is an impossible to have oral administration of the test drug 10) Patients who are pregnant, possibly pregnant, nursing or considering pregnancy 11) Others, patients who are unfit for the study as determined by the attending physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) gastrointestinal symptom (abdominal pain/distention/number of bowel movements per day after operation)
- Secondary Outcome Measures
Name Time Method 1) QOL assessment by the GSRS questionnaire 2) The evaluation of gastrointestinal motility using the cine MRI