NCT02232893

Effect of TU-100 in Patients Undergoing Laparoscopic Colectomy

A Randomized, Double-Blinded, Placebo-Controlled Trial of TU-100 in Patients Undergoing Laparoscopic Colectomy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Tsumura USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postoperative Ileus

Interventions

Type	Name	Description
DRUG	Daikenchuto (TU-100)	Subjects will receive 5g TID (15g/day) of TU-100. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 3 days before surgery and for 28 days after surgery.
DRUG	Placebo	Subjects will receive daily dose of TU-100 placebo. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 3 days before surgery and for 28 days after surgery.

Timeline

• Start date: 2014-09-01
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2014-09-05
• Last updated: 2020-06-19
• Results posted: 2020-06-19

Locations

13 sites across 1 country: United States