Ancient herbs meet modern medicine: can Curcumin-QingDai tame UC?
NCT ID NCT07665294
First seen Jun 27, 2026 · Last updated Jul 28, 2026 · Updated 2 times
Summary
This study tests whether adding a combination of curcumin (from turmeric) and QingDai (a traditional Chinese herb) to standard vedolizumab treatment can help people with moderate to severe ulcerative colitis reach remission. About 160 adults will receive either the herbal combo or a placebo, alongside their usual vedolizumab. The main goal is to see if more people achieve symptom-free remission after 12 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Curcumin-QingDai (CurQD) capsules
- What this could lead to
- If it works, this could point toward a safe, plant-based add-on therapy to help more people with ulcerative colitis achieve remission without stronger drugs.
- What could go wrong
- This is a relatively small Phase 4 trial testing a supplement combination, so results may not be definitive. The placebo effect in UC trials is often high, and QingDai has been linked to rare but serious lung and liver issues.
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 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 160 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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 to 80 years
- 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: * Age 18 to 80 years old (inclusive) at time of consent * Understand and sign the written voluntary informed consent form prior to any protocol specific procedures * History of established UC for \>3 months as determined by standard clinical criteria * Active UC defined as a modified Mayo score of 5-9 with a rectal bleeding sub score \[RBS\] ≥1 and Mayo endoscopic score \[MES\] ≥2 * Participant will have a minimum disease extent of at least 5 cm proximal from the anal verge * Subjects must be on stable doses of concomitant medications, defined as: * Participants on oral corticosteroids must be on a stable dose \>2 weeks (dose not exceeding 20 mg/day prednisone, 9mg/day of budesonide, or equivalent) prior to screening * Participants on methotrexate (MTX), azathioprine (AZA), or 6-mercaptopurine (6-MP) must be on treatment at a stable dose \>4 weeks prior to screening and until end of study * Participants on oral 5-aminosalicylates, mesalamine, or sulfasalazine must be on a stable dose for \>4 weeks prior to screening and until end of study * Probiotics or anti-diarrheal at a stable dose ≥ 2 weeks prior to Screening and until the end of study * Participants who have been diagnosed with UC for ≥8 years must be up to date on their colorectal cancer screening per local guidelines by the time of randomization. Exclusion Criteria: * Diagnosis of inflammatory bowel disease unclassified (IBD-U) or Crohn's colitis * Previously received VDZ or etrolizumab (another anti-integrin biologic therapy) * Receiving corticosteroids at a dose \>20mg/day of prednisone within two weeks prior to enrollment * Participants who have been exposed to more than one advanced therapy medication (biologic or small molecule drug) before enrollment will be excluded * Receiving or planned concomitant biologic or small targeted small molecule advanced therapy (tumor necrosis factor antagonist, interleukin \[IL\]-12/23 antagonist, IL-23 antagonist, Janus kinase \[JAK\] inhibitor and/or sphingosine-1-phosphate \[S1P\] receptor modulator) with vedolizumab * Any calcineurin inhibitor use within 4 weeks prior to screening (e.g., cyclosporine, tacrolimus) * Participant with known hepatitis B or C infection * Participant with active or latent tuberculosis (that has not been adequately treated) * Participant has any active infection * Participant has fecal sample positive for enteric infection at screening * History of prior colectomy or ileal pouch anal anastomosis * Participants with fulminant UC, toxic megacolon, or hospitalized for UC currently or within prior 2 weeks * Severe lab abnormalities including hemoglobin \< 8.0 g/dl, albumin \< 3.0 g/dl, platelets \< 100/mcl, AST \> 2X upper limit of normal (ULN), ALT \>2X ULN, total bilirubin \>1.5X ULN * Participant with history of colon cancer or colonic dysplasia not adequately treated (i.e. polyp removed) * Any serious underlying disease other than UC that in the opinion of the investigator may interfere with the participant's ability to participate fully in the study or would compromise participant safety (such as any unstable or uncontrolled medical disorder, class III or IV congestive heart failure, demyelinating disease) * History of primary sclerosing cholangitis * Renal impairment and reduced creatinine clearance defined as estimated glomerular filtration rate GFR (eGFR)\<60mL/min * History of chronic liver disease (autoimmune hepatitis, cirrhosis, etc.) * Currently requiring total parental nutrition * History of solid organ transplantation * History of malignancy or lymphoproliferative disorder in the prior 5 years, other than * adequately treated localized carcinoma in situ of the cervix or nonmetastatic squamous * cell carcinoma, or nonmetastatic basal cell carcinoma of the skin. * History of venothromboembolism (DVT or PE) or known inherited or acquired hyper coagulation disorder * Currently taking anti-platelet agent (other than aspirin) or anti-coagulant (coumadin, * rivaroxaban, etc.) * History of human immunodeficiency virus (HIV) infection * Participant is pregnant or lactating or actively trying to become pregnant
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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 places running it
1 site. The list below names each one and where it is.
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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.
Contacts and locations
Locations
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Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
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