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Ulcerative Colitis (UC)NCT07240168

CurQD as Add-On Therapy in Vedolizumab-Treated Ulcerative Colitis Patients: Retrospective Cohort Study

An observational study of Ulcerative Colitis (UC), run by Evinature Ltd. at 1 site in Israel.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 8 years and older
Conditions the study is for
Ulcerative Colitis (UC)
What is being tested?
CurQD (Curcumin + QingDai combination)
How many people
400 participants
Where
1 siteIsrael
Study dates
7 Sep 2025to 20 Aug 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: The study population will comprise adult and pediatric (age > 8 years-old) UC patients with active disease while on VDZ treatment who start CurQD combo therapy concomitantly with VDZ

Who may be able to join

  • Age >8 years
  • Diagnosis of ulcerative colitis (self-reported)
  • Completed Evinature clinical assessment between April 1, 2022, and cutoff date
  • Vedolizumab treatment at baseline
  • Active disease at entry (SCCAI ≥3 or PRO-2 ≥2 with RB ≥1)
  • Initiated CurQD at entry

Who cannot join

  • Vedolizumab for indications other than UC
  • Unclear medication status at baseline
  • Not active disease when starting CurQD

Trial locations and contacts

1 site in 1 country.

Israel1 site
  • Evinature

    Binyamina

Other trials in Israel

About this study

Official title: Drug Retention in Vedolizumab-treated Patients With Active UC After the Addition of Adjunct CurQD: A Retrospective Cohort Study

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.

Read the 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.

Being tested
CurQD (Curcumin + QingDai combination)
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CurQD (Curcumin + QingDai combination)Dietary supplement

    Patients received CurQD in addition to Vedolizumab

Study groups in NCT07240168
Study groupRoleWhat they receive
Cohort 1 (VDZ + CurQD)Patients with ulcerative colitis on Vedolizumab who initiated CurQD as adjunct therapy.
Receives: Dietary Supplement: CurQD (Curcumin + QingDai combination)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Retaining Vedolizumab Treatment at Week 12 Following Addition of CurQD

    Count of participants who remain on vedolizumab (VDZ) at Week 12 after initiating adjunct CurQD. Baseline clinical activity is defined as SCCAI ≥3 or PRO-2 ≥2 with rectal bleeding ≥1. Percentages will also be calculated relative to the number of participants with Week 12 data.

    Measured: Week 12

Secondary outcomes (11)
  1. Number of Participants Retaining Vedolizumab at Week 30

    Count of participants with ≥30 weeks of follow-up who remain on VDZ at Week 30 after starting CurQD. Percentages will also be calculated relative to the number of participants with Week 30 data.

    Measured: Week 30

  2. Number of Participants Retaining Vedolizumab at Week 54

    Count of participants with ≥54 weeks of follow-up who remain on VDZ at Week 54 after starting CurQD. Percentages will also be calculated relative to the number of participants with Week 54 data

    Measured: Week 54

  3. Number of Participants Achieving Clinical Remission at Week 12

    Clinical response is defined as SCCAI decrease ≥3, or PRO-2 decrease ≥2 with RB = 0 and SF ≤1, among participants with available baseline and follow-up values. Percentages will also be calculated relative to the number of participants with Week 12 clinical data.

    Measured: Week 12

  4. Number of Participants Achieving Clinical Response at Week 54

    Same response definition as above. Percentages will also be calculated relative to the number of participants with Week 54 clinical data.

    Measured: Week 54

  5. Number of Participants in Clinical Remission at Week 12

    Clinical remission defined as SCCAI ≤2 or PRO-2 = 0. Percentages will also be calculated relative to the number of participants with Week 12 clinical data.

    Measured: Week 12

  6. Number of Participants in Clinical Remission at Week 54

    Same remission definition as above. Percentages will also be calculated relative to the number of participants with Week 54 clinical data.

    Measured: Week 54

  7. Number of Participants Reporting Satisfaction with CurQD + Vedolizumab (VAS 1-10)

    Number of participants providing a satisfaction score using a 1-10 Visual Analog Scale (VAS) after using CurQD + VDZ. Percentages will also be calculated relative to the number of participants who completed the VAS assessment.

    Measured: Week 12

  8. Number of Participants Achieving Fecal Calprotectin (FCP) Response

    FCP response defined as ≥50% reduction from baseline among participants with baseline FCP ≥250 mcg/g and available follow-up FCP. Percentages will also be calculated relative to the number of participants with FCP measurements.

    Measured: Up to Week 54

  9. Number of Participants Achieving Fecal Calprotectin (FCP) Remission

    FCP remission defined as FCP <150 mcg/g among participants with baseline FCP ≥250 mcg/g, following STRIDE II and GEMINI-I guidance. Percentages will also be calculated relative to the number of participants with FCP measurements.

    Measured: Up to Week 54

  10. Number of Participants Experiencing Treatment-Emergent Adverse Events

    Number and type of adverse events occurring during combined CurQD + VDZ therapy. Percentages will also be calculated relative to the number of participants exposed to both therapies.

    Measured: Baseline through Week 54

  11. Sensitivity Analysis: Number of Participants Retaining Vedolizumab at Week 12 with Baseline SCCAI ≥6

    Same definition as the primary endpoint but limited to participants with moderate-severe disease (baseline SCCAI ≥6). Percentages will also be calculated relative to the number of participants in this subgroup with Week 12 data.

    Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2025
  2. Study start7 Sep 2025
  3. Primary completion20 Aug 2026 (estimated)
  4. Study completion20 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07240168
Sponsor's protocol ID
IIR-2024-200598
Status last verified
Nov 2025
First submitted
15 Sep 2025
Last updated
20 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Reinisch W, Bressler B, Curtis R, Parikh A, Yang H, Rosario M, Roseth A, Danese S, Feagan B, Sands BE, Ginsburg P, Dassopoulos T, Lewis J, Xu J, Wyant T. Fecal Calprotectin Responses Following Induction Therapy With Vedolizumab in Moderate to Severe Ulcerative Colitis: A Post Hoc Analysis of GEMINI 1. Inflamm Bowel Dis. 2019 Mar 14;25(4):803-810. doi: 10.1093/ibd/izy304.

    PubMed 30295811
  • Turner D, Ricciuto A, Lewis A, D'Amico F, Dhaliwal J, Griffiths AM, Bettenworth D, Sandborn WJ, Sands BE, Reinisch W, Scholmerich J, Bemelman W, Danese S, Mary JY, Rubin D, Colombel JF, Peyrin-Biroulet L, Dotan I, Abreu MT, Dignass A; International Organization for the Study of IBD. STRIDE-II: An Update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) Initiative of the International Organization for the Study of IBD (IOIBD): Determining Therapeutic Goals for Treat-to-Target strategies in IBD. Gastroenterology. 2021 Apr;160(5):1570-1583. doi: 10.1053/j.gastro.2020.12.031. Epub 2021 Feb 19.

    PubMed 33359090
  • Abreu MT, Rowbotham DS, Danese S, Sandborn WJ, Miao Y, Zhang H, Tikhonov I, Panaccione R, Hisamatsu T, Scherl EJ, Leong RW, Arasaradnam RP, Afif W, Peyrin-Biroulet L, Sands BE, Marano C. Efficacy and Safety of Maintenance Ustekinumab for Ulcerative Colitis Through 3 Years: UNIFI Long-term Extension. J Crohns Colitis. 2022 Aug 30;16(8):1222-1234. doi: 10.1093/ecco-jcc/jjac030.

    PubMed 35239968
  • Walsh AJ, Ghosh A, Brain AO, Buchel O, Burger D, Thomas S, White L, Collins GS, Keshav S, Travis SP. Comparing disease activity indices in ulcerative colitis. J Crohns Colitis. 2014 Apr;8(4):318-25. doi: 10.1016/j.crohns.2013.09.010. Epub 2013 Oct 10.

    PubMed 24120021
  • Ben-Horin S, Salomon N, Yanai H, Kopylov U. Letter: Change in Bowel Urgency in Active Ulcerative Colitis Patients Treated with Curcumin-QingDai (CurQD): A Post Hoc Analysis of a Randomized Placebo-Controlled Trial. J Crohns Colitis. 2025 Mar 5;19(3):jjae147. doi: 10.1093/ecco-jcc/jjae147. No abstract available.

    PubMed 39279191
  • Ben-Horin S, Salomon N, Karampekos G, Viazis N, Lahat A, Ungar B, Eliakim R, Kuperstein R, Kriger-Sharabi O, Reiss-Mintz H, Yanai H, Dotan I, Zittan E, Maharshak N, Hirsch A, Weitman M, Mantzaris GJ, Kopylov U. Curcumin-QingDai Combination for Patients With Active Ulcerative Colitis: A Randomized, Double-Blinded, Placebo-Controlled Trial. Clin Gastroenterol Hepatol. 2024 Feb;22(2):347-356.e6. doi: 10.1016/j.cgh.2023.05.023. Epub 2023 Jun 9.

    PubMed 37302449
  • Chavannes M, Kandavel P, Danialifar T, Dillman J, Polk DB, Clinical, biochemical and intestinal ultrasonography response to curcumin-QIngDai (CurQD) combination in pediatric patients with inflammatory bowel disease: A case series, Inflam Bowel Dis 2024; 30, Suppl 1, Pages S18-S19, https://doi.org/10.1093/ibd/izae020.044

  • Nachum NL, Salomon N, Yerushalmy-Feler A, Weintraub Y, Yogev D, Granot M, Haberman Y, Ben-Horin S, Weiss B. The efficacy of curcumin/Qing Dai combination in children with active ulcerative colitis: a multicenter retrospective cohort study. Front Pediatr. 2024 Sep 27;12:1342656. doi: 10.3389/fped.2024.1342656. eCollection 2024.

    PubMed 39403348
  • Yanai H, Salomon N, Lahat A, Ungar B, Eliakim R, Kriger-Sharabi O, Reiss-Mintz H, Koslowsky B, Shitrit AB, Tamir-Degabli N, Dotan I, Zittan E, Maharshak N, Hirsch A, Ben-Horin S, Kopylov U. Real-world experience with Curcumin-QingDai combination for patients with active ulcerative colitis: A retrospective multicentre cohort study. Aliment Pharmacol Ther. 2023 Jul;58(2):175-181. doi: 10.1111/apt.17538. Epub 2023 May 8.

    PubMed 37157131
  • Zittan E, Mahajna H, Salomon N. Attitudes Toward Integrative Medicine in Inflammatory Bowel Disease: A Survey Among Israeli Inflammatory Bowel Disease Experts. Inflamm Bowel Dis. 2023 Sep 1;29(9):e35-e36. doi: 10.1093/ibd/izad072. No abstract available.

    PubMed 37116868
  • Ben-Horin S, Kopylov U, Salomon N. Curcumin-QingDai Combination as Treatment for Moderate-Severe Ulcerative Colitis. Case Rep Gastroenterol. 2022 Sep 20;16(3):563-568. doi: 10.1159/000526646. eCollection 2022 Sep-Dec.

    PubMed 36824698

Questions about this trial

What is this clinical trial studying?

An observational study of Ulcerative Colitis (UC), run by Evinature Ltd. at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Retaining Vedolizumab Treatment at Week 12 Following Addition of CurQD (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07240168, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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