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
Not Applicable
- Conditions
- Gastrointestinal symptom (disorder of defecation, abdominal bloating) after colorectal cancer surgery
- Registration Number
- JPRN-UMIN000007388
- Lead Sponsor
- Department of surgery, division of frontier medical science, programs for biomedical research, Graduate school of biomedical sciences, Hiroshima university
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1)total number of elimination of the radiopaque markers 2) oro-cecal transit time 3) GSRS (Japanese Version) Score 4) VAS 5) GVS
- Secondary Outcome Measures
Name Time Method 1) segmental transit time(gastric emptying, small intestinal transit, and colonic transit (right, left, and rectosigmoid colon)) 2) safety