Ignite Creation Date:
2025-12-24 @ 11:48 AM
Ignite Modification Date:
2025-12-24 @ 11:48 AM
Study NCT ID:
NCT00266461
Status:
COMPLETED
Last Update Posted:
2013-07-12
First Post:
2005-12-14
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Tolerability and Efficacy Study of TU-100 For The Treatment of Postoperative Ileus
Sponsor:
Tsumura USA
Organization:
Study Overview
Official Title:
A Randomized, Controlled, Open-Label Tolerability And Efficacy Study Of TU-100 For The Treatment Of Postoperative Ileus In Patients Undergoing Laparotomy For Large Bowel Resection
Status:
COMPLETED
Status Verified Date:
2012-06
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:
None
Brief Summary:
Postoperative ileus (POI), a transient impairment of gastrointestinal (GI) motility, commonly occurs in patients who have undergone abdominal surgery and contributes to postoperative morbidity, including delayed enteral nutrition, increased patient discomfort, and prolonged hospitalization. POI appears to be have many causes, with activation of inhibitory reflexes, inflammatory responses, and the effects of anesthesia and analgesics all playing roles. However, there is no approved pharmacological therapy for the treatment and prevention of POI.
Daikenchuto (TU-100) is an herbal formulation consisting of Asian ginseng, Zanthoxylum fruit (Sichuan pepper), ginger, and malt sugar, which was originally described in Jin kui yao lue, the classical medical textbook written in ancient China in the third century by Zhang Zhong Jing. Since it was introduced to Japan, Daikenchuto has been used in the treatment of abdominal pain and a feeling of coldness in the abdomen.
TSUMURA Daikenchuto Extract Granules, Product Code TU-100, is a modern herbal product manufactured in the dosage form of granules by Tsumura \& Co. The current Tsumura product, TU-100, was approved for manufacture as a prescription drug in 1986 by the Japanese Ministry of Health and Welfare and has been sold commercially as a prescription Kampo (a generic term for the system of traditional medicine that was developed in Japan after being introduced from China in the fourth century) drug in Japan for many years. The drug product proposed for use in the clinical studies is identical to the drug currently sold in Japan. In addition, all three botanical components and maltose syrup powder are considered as food substances and are currently part of the United States food supply.
The purpose of this study evaluate the tolerability, efficacy and safety of TU-100 for the treatment of postoperative ileus (POI) in patients undergoing laparotomy for large bowel resection
Daikenchuto (TU-100) is an herbal formulation consisting of Asian ginseng, Zanthoxylum fruit (Sichuan pepper), ginger, and malt sugar, which was originally described in Jin kui yao lue, the classical medical textbook written in ancient China in the third century by Zhang Zhong Jing. Since it was introduced to Japan, Daikenchuto has been used in the treatment of abdominal pain and a feeling of coldness in the abdomen.
TSUMURA Daikenchuto Extract Granules, Product Code TU-100, is a modern herbal product manufactured in the dosage form of granules by Tsumura \& Co. The current Tsumura product, TU-100, was approved for manufacture as a prescription drug in 1986 by the Japanese Ministry of Health and Welfare and has been sold commercially as a prescription Kampo (a generic term for the system of traditional medicine that was developed in Japan after being introduced from China in the fourth century) drug in Japan for many years. The drug product proposed for use in the clinical studies is identical to the drug currently sold in Japan. In addition, all three botanical components and maltose syrup powder are considered as food substances and are currently part of the United States food supply.
The purpose of this study evaluate the tolerability, efficacy and safety of TU-100 for the treatment of postoperative ileus (POI) in patients undergoing laparotomy for large bowel resection
Detailed Description:
This is a randomized, controlled, open-label study designed to evaluate the tolerability and efficacy of TU-100 for the treatment of POI in patients undergoing laparotomy for large bowel resection. It will be conducted at multiple centers in the United States. A total of 24 patients will be enrolled in the study. Patient participation in the study will last for up to 32 days (from Screening to postoperative day 10 \[POD 10\] or until the time when a discharge order is written for the patient, whichever comes first), with follow-up safety assessments to occur 7 and 14 days after the last dose of study medication.
Study Oversight
Has Oversight DMC:
False
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?: