Effect of TU-100 in Patients Undergoing Laparoscopic Colectomy

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.

Timeline

Start

2014-09

Primary completion

2017-05

Completion

2017-05

Outcome

Missed primary endpoint

registry analysis (superiority test); TU-100 vs Placebo; p >0.05; ANCOVA NCT02232893 ↗

Drugs

Indications