CURVE-UC: A Pragmatic Randomized, Double-blind, Placebo Controlled, Treat-through, Multi-site Pragmatic Interventional Study to Evaluate the Efficacy and Safety of Combination Curcumin-QingDai (CurQD) With Vedolizumab in Moderate to Severe Ulcerative Colitis (UC)
Ryan C Ungaro
Summary
The purpose of this research study is to test the efficacy and safety of the study intervention, CurQD or placebo (non-active pill), in combination with vedolizumab prescribed as standard of care for patients with ulcerative colitis (UC)..
Description
A prospective, 30-weeks long, treat-through, multi-center, parallel-group, double blind, placebo controlled, randomized pragmatic clinical trial to examine if there is added clinical benefit in participants with active UC receiving a combination VDZ+CurQD versus VDZ alone (with placebo). Moderately to severely active UC participants for whom VDZ was prescribed by their physician irrespective of the present trial as part of routine clinical care will be eligible. Moderate to severely active UC will be defined as a modified Mayo score of 5 to 9, with rectal bleeding score of ≥1, and with a sigmo…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugCurQD
Capsule doses 235mg - 385mg curcumin/150mg-300mg QingDai
- DrugPlacebo
Matching capsules
- DrugVedolizumab
as prescribed by participant's provider as part of routine clinical care
Location
- Icahn School of Medicine at Mount SinaiNew York, New York