Curcumin for Prevention of Relapse in Patients With Ulcerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 24 October 2022
• Main ID: NCT03122613
• Date of registration: 07/04/2017
• Prospective Registration: Yes
• Primary sponsor: Chinese University of Hong Kong
• Public title: Curcumin for Prevention of Relapse in Patients With Ulcerative Colitis
• Scientific title: A Double-blind, Randomized, Placebo-Controlled Trial of Curcumin Versus Placebo for Prevention of Relapse in Patients With Ulcerative Colitis
• Date of first enrolment: June 19, 2017
• Target sample size: 29
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03122613
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Double (Participant, Investigator).
• Phase: N/A

Countries of recruitment

Hong Kong

Contacts

• Name: Siew Ng, Prof.
• Affiliation: Chinese University of Hong Kong

Key inclusion & exclusion criteria

Inclusion Criteria:

- in clinical remission for at least 1 month, defined as Mayo bowel frequency subscore =
1 and Mayo rectal bleeding subscore = 0 (Table 2).

- a history of at least one flare with symptoms that required intervention within 24
months before screening

- age = 18

- written informed consent obtained

Exclusion Criteria:

- receipt of immunosuppressive drugs or corticosteroids within 60 days of screening

- prior bowel surgery except appendectomy

- with severe relapse (Mayo score 9-12) in the last 3 months

- History or evidence of incompletely resected colonic mucosal dysplasia

- on regular curcumin supplements or intake of curry in diet for =5 days each week

- presence of infections (exclude simple infections such as influenza, etc.) or sepsis

- pregnancy or lactating women

- with a Mayo endoscopic subscore =2 on sigmoidoscopy or colonoscopy at baseline

- allergic to curry-related products



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis in Remission

Intervention(s)

Dietary Supplement: Curcumin

Drug: Placebo

Primary Outcome(s)

The relapse rate at 12 months [Time Frame: 1 year]

Secondary Outcome(s)

Pharmacokinetics study to measure the drug concentration-time courses [Time Frame: 1 year]

Quality of Life assessed by the Inflammatory Bowel Disease Questionnaire (IBDQ) [Time Frame: 1 year]

Endoscopic remission [Time Frame: 1 year]

Fecal immunochemical test (FIT) at 12 months [Time Frame: 1 year]

Simple Clinical Colitis Activity Index (SCCAI) [Time Frame: 1 year]

Fecal calprotectin levels at 12 months [Time Frame: 1 year]

Adverse events [Time Frame: 1 year]

Patient Reported Outcomes (PRO) Questionnaire [Time Frame: 1 year]

Secondary ID(s)

CUR2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors