Randomized Double-Blind Placebo-Controlled Phase 2 Trial to Evaluate the Safety and Efficacy of TU-100 as an Adjunct to an Enhanced Recovery after Surgery (ERAS) Protocol in Subjects Undergoing Bowel Resection

Brief description of study

Tsumura, USA, Inc. (Tsumura) has begun a study of an investigational drug (also known as the “study drug”) called TU-100 (daikenchuto) as a possible add-on therapy (or adjunct therapy) to improve gastrointestinal recovery in individuals who have undergone surgery for bowel resection.

TU-100 has been previously approved as a prescription drug in Japan by the Japanese Ministry of Health and Welfare and has been sold commercially for many years there. TU-100 consists of ginseng, Zanthoxylum fruit, and ginger. All 3 of these components are considered food substances and are part of the US food supply; however, TU-100 is considered an investigational drug in the United States (US). An investigational drug is one that has not been approved by the US Food and Drug Administration (FDA).

The main purpose of this study is to learn how well the study drug works and how safe the study is when used during recovery from surgery compared to placebo when given in addition to an enhanced recovery care following bowel resection surgery.


Clinical Study Identifier: s21-00309
ClinicalTrials.gov Identifier: NCT04742907
Principal Investigator: Toyooki Sonoda.
Other Investigators: Patrick Austria Hartendorp, Nadege St. Hubert, Matthew Symer.


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