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

NCT07240168 | Active Not Recruiting

• 1 other identifier: IIR-2024-200598
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis (UC)

Outcome Measures

Primary Outcomes (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.

  Week 12

Secondary Outcomes (11)

• Number of Participants Retaining Vedolizumab at Week 30

  Week 30

• Number of Participants Retaining Vedolizumab at Week 54

  Week 54

• Number of Participants Achieving Clinical Remission at Week 12

  Week 12

• Number of Participants Achieving Clinical Response at Week 54

  Week 54

• Number of Participants in Clinical Remission at Week 12

  Week 12

Study Arms (1)

Cohort 1 (VDZ + CurQD)

Patients with ulcerative colitis on Vedolizumab who initiated CurQD as adjunct therapy.

Dietary Supplement: CurQD (Curcumin + QingDai combination)

Interventions

CurQD (Curcumin + QingDai combination) DIETARY_SUPPLEMENT

Patients received CurQD in addition to Vedolizumab

Cohort 1 (VDZ + CurQD)

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Evinature Ltd.: lead
• Sheba Medical Center: collaborator
• Takeda Pharmaceuticals U.S.A., Inc.: collaborator

Study Sites (1)

Evinature

Binyamina, Israel

Location

Related Publications (11)

• 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.

  PMID: 30295811 RESULT

• 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.

  PMID: 33359090 RESULT

• 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.

  PMID: 35239968 RESULT

• 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.

  PMID: 24120021 RESULT

• 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.

  PMID: 39279191 RESULT

• 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.

  PMID: 37302449 RESULT

• 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

  RESULT

• 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.

  PMID: 39403348 RESULT

• 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.

  PMID: 37157131 RESULT

• 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.

  PMID: 37116868 RESULT

• 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.

  PMID: 36824698 RESULT

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Shomron Ben-Horin

  Evinature Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: November 20, 2025
• Study Start: September 7, 2025
• Primary Completion (Estimated): August 20, 2026
• Study Completion (Estimated): August 20, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)