A Tolerability and Efficacy Study of TU-100 For The Treatment of Postoperative Ileus
Status:
Completed
Trial end date:
2008-01-01
Target enrollment:
Participant gender:
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