Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2026-01-01 @ 6:14 PM
Study NCT ID:
NCT02232893
Status:
COMPLETED
Last Update Posted:
2020-06-19
First Post:
2014-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of TU-100 in Patients Undergoing Laparoscopic Colectomy
Sponsor:
Tsumura USA
Organization:
Study Overview
Official Title:
A Randomized, Double-Blinded, Placebo-Controlled Trial of TU-100 in Patients Undergoing Laparoscopic Colectomy
Status:
COMPLETED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TU100P2T3
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: