CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 69 enrolled
Drug / intervention
Daikenchuto (TU-100) +1 moredrug
Likely dose
Daikenchuto (TU-100) 5gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02232893
NCT02232893Phase 2Completed
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A Randomized, Double-Blinded, Placebo-Controlled Trial of TU-100 in Patients Undergoing Laparoscopic Colectomy

Tsumura USA·interventional·Posted Sep 5, 2014·Updated Jun 19, 2020

In Brief

A Phase 2 clinical trial evaluating Daikenchuto (TU-100) and Placebo for Postoperative Ileus. Completed, enrolled 69 participants across 13 sites.

Detailed 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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostoperative Ileus
CountriesUnited States
CollaboratorsCato Research

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 5, 2014
Enrollment StartSep 1, 2014
Primary CompletionMay 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 11.8 years ago

Interventions

Daikenchuto (TU-100)drug

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.

Placebodrug

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.