Effect of TU-100 in Patients Undergoing Laparoscopic Colectomy

Phase 2

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Daikenchuto (TU-100)	Daikenchuto (TU-100)	Daikenchuto (TU-100) 5g TID (15g/day)
Placebo	Placebo	Placebo TID

Primary Outcome Measures

Name	Time	Method
Quality of Life After Surgery Based on Gastrointestinal Quality of Life Index (GIQLI) Global Score From Baseline to Visit 4.	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 Outcome Measures

Name	Time	Method

Locations (13): Weston Site
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Weston, Florida, United States
Metairie Site
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Metairie, Louisiana, United States
Aurora Site
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Aurora, Colorado, United States
Los Angeles Site
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Los Angeles, California, United States
Atlanta Site
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Atlanta, Georgia, United States
Coon Rapids Site
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Coon Rapids, Minnesota, United States
Cleveland Site
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Cleveland, Ohio, United States
Chicago Site
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Chicago, Illinois, United States
Burlington, MA Site
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Burlington, Massachusetts, United States
Jackson Site
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Jackson, Mississippi, United States
Spokane Site
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Spokane, Washington, United States
Burlington, VT Site
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Burlington, Vermont, United States
Minneapolis Site
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Minneapolis, Minnesota, United States