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Ancient herbs meet modern medicine: can Curcumin-QingDai tame UC?

NCT ID NCT07665294

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 80 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

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