Clinical efficacy of Daikenchuto (DKT: TJ-100) for gastrointestinal dysfunction following open total gastrectomy (a randomized, double-blind, multi-center, placebo-controlled study)

Phase 3

• Conditions: Gastric cancer

• Registration Number: JPRN-UMIN000004693
• Lead Sponsor: Japanese Foundation for Multidisciplinary Treatment of Cancer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-01-01
• Study Completion: 2013-03-15
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients with history of chemotherapy or within 4weeks before surgery or scheduled to undergo chemotherapy during the test drug administration 2) Perioperative radiotherapy 3) Patients with history of radiotherapy to the abdomen 4) Patiens scheculed to be under postoperative artificial respiration after surgery 5) Patients with inflammatory bowel disease (ulcerative colitis, Crohn disease)(including anamnestic case) 6) Patients requiring emergency surgery 7) Patients with multiple cancer 8) Patients with peritoneum metastasis 9) Patients with synchronous colon resection 10) Insuufficient organ functions 11) Patients with history of colon resections 12) Patients with history of laparotomy and peritonitis (excludeing surgery for appendicitis) 13) Patients who are administered another Kampo medicines for medical treatment within 4weeks before the test drug administration 14) Patients who are pregnant, possibly pregnant, nursing or considering pregnancy 15) Others, patients who are unfit for the study as determined by the attending physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified