A Randomized, Double-Blinded, Placebo-Controlled Trial of TU-100 in Patients Undergoing Laparoscopic Colectomy
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 69
- Locations
- 13
- Primary Endpoint
- Quality of Life After Surgery Based on Gastrointestinal Quality of Life Index (GIQLI) Global Score From Baseline to Visit 4.
Study Overview
Brief Summary
TU-100 is a gastrointestinal drug produced from the three botanical raw materials, Asian ginseng, Zanthoxylum fruit (Japanese pepper), and ginger, based on proprietary aqueous decoction and granulation technology. The aim of this study is to assess the effect of TU-100 on post-operative quality of life during the 4 week postoperative period after straight, hand-assisted, or robot-assisted laparoscopic colectomy. Optimal efficacy parameters for subsequent outcome studies also will be explored.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Be at least 18 years of age
- •Has a current diagnosis of colon cancer, diverticulitis, or benign colonic neoplasm
- •Requires straight, hand-assisted, or robot-assisted laparoscopic colectomy
- •Requires hospitalization for surgery and recovery
Exclusion Criteria
- •Has been diagnosed with rectal cancer, advanced or metastatic colon cancer, Crohn disease, ulcerative colitis, or volvulus
- •Requires resection of rectal lesion
- •Has received or is scheduled to receive chemotherapy during the duration of the study
- •Is a pregnant or lactating female
- •Has diabetic neuropathy
- •Has a history or presence of diabetic gastroparesis
- •Has a compromised immune system, either from treatment with corticosteroids or other immunosuppressive agent within 2 weeks of surgery or from immunosuppressive disease (e.g., human immunodeficiency virus)
- •Has any other serious condition that might adversely affect suitability for participation in this study, such as liver disorder (including alanine aminotransferase or aspartate aminotransferase level greater than 2.5 times the upper limit of normal), kidney disorders, heart failure, blood disorders, or metabolic disorders
- •Has a history or presence of interstitial pneumonia
- •Has a history of allergic reaction to ginseng, ginger or Zanthoxylum fruit (Japanese pepper)
- •Plans to receive any abdominal irradiation
- •Is clinically lactose intolerant
Arms & Interventions
Daikenchuto (TU-100)
Daikenchuto (TU-100) 5g TID (15g/day)
Intervention: Daikenchuto (TU-100) (Drug)
Placebo
Placebo TID
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Quality of Life After Surgery Based on Gastrointestinal Quality of Life Index (GIQLI) Global Score From Baseline to Visit 4.
Time Frame: Baseline and 15 days
The primary endpoint was change in The Gastrointestinal Quality of Life Index (GIQLI) global score from baseline to Visit 4 (Day 15 minus baseline). The global score could range from 0 (lowest quality of life) to 144 (highest quality of life). The effect of TU-100 on the change in GIQLI global score from baseline was assessed by using an analysis of covariance (ANCOVA) model with treatment group as a fixed effect and with baseline GIQLI global score, scheduled surgical location in the colon, and solid food before/after the first flatus as covariates.
Secondary Outcomes
No secondary outcomes reported