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Clinical effectiveness of daikenchuto(TJ-100) on gastrointestinal symptoms such as abdominal pain and distention after distal gastrectomy in gastric cancer patients.

Clinical effectiveness of daikenchuto(TJ-100) on gastrointestinal symptoms such as abdominal pain and distention after distal gastrectomy in gastric cancer patients. - Clinical effectiveness of daikenchuto(TJ-100) on gastrointestinal symptom after distal gastrectomy in gastric cancer patients.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000006055
Enrollment
60
Registered
2011-08-01
Start date
2011-12-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric cancer patients with gastrointestinal symptom (abdominal pain, distention) after distal gastrectomy

Interventions

Oral administration of daikenchuto(15.0g/day, t.i.d.) before meals from postoperative day 2 to postoperative day 9. (postoperative day 2 at before an evening meal start administration.) Standard of c

Sponsors

SHIGA UNIVERSITY OF MEDICAL SCIENCE HOSPITAL
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: In order to participate in this study, a patient must meet all of the following criteria. 1) Patietnt with Clinical Stage: IA-IIB before surgery 2) Patient who recieved open or laparoscopic gastrectomy 3) Patient with abdominal pain and distention 1day after surgery 4) Patient with reconstruction: Billroth I 5) Patient with PS (ECOG Performance Status Scale): 0,1 6) Age: 20 years or older, under 75 years 7) Gender: no specification 8) Inpatient/Outpatient: Inpatient 9) Patient who can provide written informed consent

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
1) gastrointestinal symptom (abdominal pain/distention/number of bowel movements per day after operation)

Secondary

MeasureTime frame
1) QOL assessment by the GSRS questionnaire 2) The evaluation of gastrointestinal motility using the cine MRI

Countries

Japan

Contacts

Public ContactHiroshi Yamamoto

SHIGA UNIVERSITY OF MEDICAL SCIENCE HOSPITAL Gastroenterological Surgery

yiroshi@belle.shiga-med.ac.jp077-548-2238

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026