Ancient herbal blend may get bowels moving after surgery
NCT ID NCT07765589
First seen Aug 14, 2026 · Last updated Aug 14, 2026
Summary
This phase 2 trial tests whether TU-100, a traditional Japanese herbal medicine made from ginger, ginseng, and Japanese pepper, can help the gut recover faster after major abdominal or pelvic surgery. About 240 adults undergoing either bladder removal (radical cystectomy) or complex abdominal wall reconstruction will receive TU-100 or a placebo alongside standard enhanced recovery care. The main goal is to see if more patients achieve normal bowel function within three days after surgery, which could reduce the risk of postoperative ileus—a common complication where the gut temporarily stops working.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TU-100, a traditional Japanese herbal medicine made from processed ginger, ginseng, and Japanese pepper
- What this could lead to
- If effective, TU-100 could become a standard add-on to recovery protocols, helping patients regain bowel function faster after major surgery and potentially shortening hospital stays.
- What could go wrong
- This is a phase 2 trial, so results are preliminary. The herbal mixture may not outperform placebo, and its safety in surgical patients is still being evaluated.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 240 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male or female participants aged 18 years or older * American Society of Anesthesiologists (ASA) Physical Status Classification I-III * Scheduled to undergo elective open or minimally invasive Radical Cystectomy (RC) with continent or incontinent urinary diversion requiring bowel resection, or open or complex minimally invasive surgery for Complex Abdominal Wall Reconstruction (CAWR) with anticipated myofascial advancement flap and mesh placement for moderate or giant hernia defects * Body mass index (BMI) ≤40 kg/m² * Women of childbearing potential and men with partners of childbearing potential must agree to use highly effective contraception * Willing and able to comply with study procedures and able to voluntarily provide informed consent Exclusion Criteria: * Not scheduled for a Radical Cystectomy (RC) or Complex Abdominal Wall Reconstruction (CAWR) procedure meeting the inclusion criteria * Known gastric or bowel obstruction * Have had or have planned gastrectomy, gastric bypass, colostomy, or ileostomy * Significant gastrointestinal motility disorders * Pregnancy or breastfeeding * Clinically significant hepatic, renal, cardiovascular, or other uncontrolled medical conditions * Immunocompromised state or recent immunosuppressive therapy
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.