Safety and Efficacy of TU-100 as an Adjunct to an Enhanced Recovery After Surgery in Subjects Undergoing Bowel Resection

Summary

This multicenter, randomized, double-blinded, placebo-controlled study will evaluate the effect of TU-100 on resolution of postoperative ileus (POI) in subjects undergoing open or laparoscopic bowel resection (BR).

Timeline

Start

2021-07-29

Primary completion

2024-03-25

Completion

2024-05-01

Outcome

Missed primary endpoint

registry analysis (superiority test); TU-100 15 g/Day vs Placebo; p = 0.767 NCT04742907 ↗

registry analysis (superiority test); TU-100 7.5 g/Day vs Placebo; p = 0.107 NCT04742907 ↗

Publications

• Nedeljkovic SS, Silinsky JD, Nagle D, Lee SW, Ayad S, Segura-Vasi AM, Fleshner PR, Choti MA, Wren SM, Kosaka B Pharm J, Tanaka Y, Li YP, Rachfal AW, Techner LM, Gan TJ, Fichera A, Michelassi F. Evaluation of TU-100 (Daikenchuto), a Traditional Japanese Kampo Medicine, as an Adjunct to Enhanced Recovery After Surgery, for Acceleration of Gastrointestinal Recovery After Bowel Resection: Results of a Proof-of-Concept, Phase 2, Randomized, Double-Blinded, Placebo-Controlled Trial. Dis Colon Rectum. 2026 Jan 1;69(1):73-86. doi: 10.1097/DCR.0000000000003990. Epub 2025 Oct 20.
• Ezoe A, Shimada Y, Sawada R, Douke A, Shibata T, Kadowaki M, Yamanishi Y. Pathway-based prediction of the therapeutic effects and mode of action of custom-made multiherbal medicines. Mol Inform. 2024 Nov;43(11):e202400108. doi: 10.1002/minf.202400108. Epub 2024 Oct 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	TU-100	Traditional medicine (herbal / TCM)	2.5 g	Oral
Subject	TU-100	Traditional medicine (herbal / TCM)	5 g	Oral

Indications

No indication recorded.