Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2025-12-25 @ 3:48 PM
Study NCT ID:
NCT07240168
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-20
First Post:
2025-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CurQD as Add-On Therapy in Vedolizumab-Treated Ulcerative Colitis Patients: Retrospective Cohort Study
Sponsor:
Evinature Ltd.
Organization:
Study Overview
Official Title:
Drug Retention in Vedolizumab-treated Patients With Active UC After the Addition of Adjunct CurQD: A Retrospective Cohort Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to evaluate whether adding CurQD, a nutraceutical composed of Curcumin and QingDai, improves treatment outcomes in patients with active ulcerative colitis (UC) who are already receiving Vedolizumab but still have ongoing disease activity. The study will use de-identified patient records collected through Evinature's global data platform. We will examine whether the addition of CurQD helps patients stay on Vedolizumab longer, improves symptoms and biomarkers, and increases satisfaction with treatment.
Detailed Description:
Curcumin and QingDai, (Indigo, QD) are two herbal traditional medicine compounds which have been investigated for their use in mild-moderate and moderate-severe UC, respectively. A combination of Curcumin and QD (CurQD), which was developed at Sheba Medical Center to maximize clinical efficacy while reducing long-term high-dose QD exposure, has been used in clinical practice in Israel since 2015 and has gained wide acceptance by UC patients and IBD experts \[1,2\]. In two multi-center retrospective studies, CurQD was found effective in inducing clinical and biomarker remission in both adult and pediatric patients, including in patients who were refractory to biologic and/or small molecules \[3,4\], and recent evidence from a pediatric cohort in the U.S also documented intestinal sonographic response to CurQD \[5\]. In a placebo-controlled randomized trial from Israel and Greece, CurQD was found superior to placebo in inducing and maintaining clinical and endoscopic remission without any safety signals \[6,7\]. Moreover, the study also showed the active compounds in CurQD exerts agonistic up-regulation of Aryl-hydrocarbon Receptor pathway in the rectal mucosa \[6\], supporting its unique non-immunosuppressive mode-of-action. Subsequently, CurQD has been increasingly used by IBD experts in academic centers in the USA and elsewhere as Add-on therapy in patients with partial or non-response to biologics and/or small molecules medications. Recently, CurQD became the first and only nutraceutical to date to pass the CCFA Ingestible committee examination of supporting clinical and scientific data to allow its endorsement by the CCFA. Collectively, these data provide the rationale for exploring large scale population-based impact of combining CurQD with a biologic.
The present retrospective cohort study will interrogate the Evinature GDPR HIPAA compliant database to identify patients who started CurQD while being treated with VDZ. The study will investigate the clinical benefit of adding CurQD in combination with VDZ, in patients partially responding or not-responding to VDZ.
The present retrospective cohort study will interrogate the Evinature GDPR HIPAA compliant database to identify patients who started CurQD while being treated with VDZ. The study will investigate the clinical benefit of adding CurQD in combination with VDZ, in patients partially responding or not-responding to VDZ.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: