- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03122613
Curcumin for Prevention of Relapse in Patients With Ulcerative Colitis
A Double-blind, Randomized, Placebo-Controlled Trial of Curcumin Versus Placebo for Prevention of Relapse in Patients With Ulcerative Colitis
UC is a chronic inflammatory bowel disorder with relapsing and remitting course. The efficacy of mesalazine in preventing relapse in patients with UC is well-known and supported by randomized studies. However, mesalazine can be associated with side-effects. In addition, drug compliance is suboptimal, especially when disease is not active. Curcumin is a natural phytochemical derived from the Indian spice turmeric. It is widely used, has potent anti-inflammatory, anti-oxidant and anti-tumour properties.
The aims of this double-blind, placebo-controlled randomized trial is to assess the efficacy of curcumin in the prevention of relapse in patients with ulcerative colitis (UC).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
UC is a chronic inflammatory bowel disorder with relapsing and remitting course. The incidence of UC in Hong Kong has increased by 30-fold in the past three decades. The efficacy of mesalazine in preventing relapse in patients with UC is well-known and supported by randomized studies. However, mesalazine can be associated with side-effects. In addition, drug compliance is suboptimal, especially when disease is not active. Without mesalazine, the risk of relapse in UC in one year is approximately 60-70%. Repeated flares are disabling for the patient, and lead to increased hospitalisations, anatomical extension of disease, and increased cancer risk. In Hong Kong, 90 percent of patients with UC have low to medium compliance to mesalazine, and 50 percent would prefer the use of a complementary or alternative therapy to maintain disease remission. Identification of a natural product that is effective, acceptable, inexpensive and non-toxic remains an unmet need in patients with UC.
Curcumin is a natural phytochemical derived from the Indian spice turmeric. It is widely used, has potent anti-inflammatory, anti-oxidant and anti-tumour properties. Preclinical studies in experimental animals showed that curcumin is effective in preventing colitis. We reported in a randomized study that curcumin is effective in the induction of remission in patients with mild to moderately active UC. Although curcumin is popular amongst patients with inflammatory bowel disease, its efficacy in maintaining disease remission in UC is uncertain. We propose a double-blind, placebo-controlled trial to assess the efficacy of curcumin in preventing clinical relapse in patients with UC. Patients will be randomised to 2 gram curcumin once daily or an equivalent placebo for 12 months. The primary outcome is the rate of clinical relapse at 12 months. Secondary outcomes include adverse events, endoscopic remission, fecal calprotectin levels and time to relapse.
Because the use of curcumin is already popular in Asia, this important clinical question will not be a priority of pharmaceutical companies. If proven, this industry-independent trial will be a landmark study that identifies an alternative effective treatment to maintain disease remission in patients with UC. Regardless of the outcome, it will inform clinical practice and provide invaluable data to international guideline committees on the management of this chronic inflammatory disease.
The aims of this double-blind, placebo-controlled randomized trial is to assess the efficacy of curcumin in the prevention of relapse in patients with ulcerative colitis (UC).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Hong Kong, Hong Kong, 0000
- Prince of Wales Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Curcumin
Dietary supplements of Curcumin capsules
|
3g of Curcumin per day
Other Names:
|
Placebo Comparator: Curcumin Placebo
Identical looking placebo of the active arm
|
3g of Curcumin Placebo per day
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The relapse rate at 12 months
Time Frame: 1 year
|
Defined as clinical symptoms (increased bowel frequency with a bowel frequency Mayo subscore ≥ 1 or rectal bleeding with a Mayo rectal bleeding subscore ≥ 1) together with endoscopic evidence of active disease (Mayo endoscopic subscore ≥ 2).
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse events
Time Frame: 1 year
|
The severity grading of AEs will be assessed as Grade 1, 2, 3, 4 or 5 using the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 Grading Scale, which can be found at: http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_8.5x11.pdf |
1 year
|
Endoscopic remission
Time Frame: 1 year
|
Defined as a mayo endoscopic subscore of 0 or 1
|
1 year
|
Simple Clinical Colitis Activity Index (SCCAI)
Time Frame: 1 year
|
compare the scores in two groups
|
1 year
|
Fecal calprotectin levels at 12 months
Time Frame: 1 year
|
compare the difference of the levels between groups
|
1 year
|
Fecal immunochemical test (FIT) at 12 months
Time Frame: 1 year
|
compare the positivity rate in those with flare
|
1 year
|
Quality of Life assessed by the Inflammatory Bowel Disease Questionnaire (IBDQ)
Time Frame: 1 year
|
compare the scores in two groups
|
1 year
|
Patient Reported Outcomes (PRO) Questionnaire
Time Frame: 1 year
|
The questionnaire will ask during the study follow up about the psychological aspects of UC patients, the baseline and score on final visit will be compared, as well as between the two groups
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1 year
|
Pharmacokinetics study to measure the drug concentration-time courses
Time Frame: 1 year
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compare the absorption rate in two groups and to establish and evaluate the relationships and subsequently describe the effect-time courses of curcumin absorption in blood and colon.
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Siew Ng, Prof., Chinese University of Hong Kong
Publications and helpful links
General Publications
- Vecchi Brumatti L, Marcuzzi A, Tricarico PM, Zanin V, Girardelli M, Bianco AM. Curcumin and inflammatory bowel disease: potential and limits of innovative treatments. Molecules. 2014 Dec 16;19(12):21127-53. doi: 10.3390/molecules191221127.
- Dignass A, Lindsay JO, Sturm A, Windsor A, Colombel JF, Allez M, D'Haens G, D'Hoore A, Mantzaris G, Novacek G, Oresland T, Reinisch W, Sans M, Stange E, Vermeire S, Travis S, Van Assche G. Second European evidence-based consensus on the diagnosis and management of ulcerative colitis part 2: current management. J Crohns Colitis. 2012 Dec;6(10):991-1030. doi: 10.1016/j.crohns.2012.09.002. Epub 2012 Oct 3. No abstract available. Erratum In: J Crohns Colitis. 2022 Aug 16;:
- Feagan BG, Macdonald JK. Oral 5-aminosalicylic acid for maintenance of remission in ulcerative colitis. Cochrane Database Syst Rev. 2012 Oct 17;10:CD000544. doi: 10.1002/14651858.CD000544.pub3.
- Kane S, Huo D, Aikens J, Hanauer S. Medication nonadherence and the outcomes of patients with quiescent ulcerative colitis. Am J Med. 2003 Jan;114(1):39-43. doi: 10.1016/s0002-9343(02)01383-9.
- Kane SV, Cohen RD, Aikens JE, Hanauer SB. Prevalence of nonadherence with maintenance mesalamine in quiescent ulcerative colitis. Am J Gastroenterol. 2001 Oct;96(10):2929-33. doi: 10.1111/j.1572-0241.2001.04683.x.
- Sewitch MJ, Abrahamowicz M, Barkun A, Bitton A, Wild GE, Cohen A, Dobkin PL. Patient nonadherence to medication in inflammatory bowel disease. Am J Gastroenterol. 2003 Jul;98(7):1535-44. doi: 10.1111/j.1572-0241.2003.07522.x.
- Leong RW, Lawrance IC, Ching JY, Cheung CM, Fung SS, Ho JN, Philpott J, Wallace AR, Sung JJ. Knowledge, quality of life, and use of complementary and alternative medicine and therapies in inflammatory bowel disease: a comparison of Chinese and Caucasian patients. Dig Dis Sci. 2004 Oct;49(10):1672-6. doi: 10.1023/b:ddas.0000043384.26092.f4.
- Bernstein CN. Treatment of IBD: where we are and where we are going. Am J Gastroenterol. 2015 Jan;110(1):114-26. doi: 10.1038/ajg.2014.357. Epub 2014 Dec 9.
- Hilsden RJ, Verhoef MJ, Rasmussen H, Porcino A, DeBruyn JC. Use of complementary and alternative medicine by patients with inflammatory bowel disease. Inflamm Bowel Dis. 2011 Feb;17(2):655-62. doi: 10.1002/ibd.21360.
- Rawsthorne P, Clara I, Graff LA, Bernstein KI, Carr R, Walker JR, Ediger J, Rogala L, Miller N, Bernstein CN. The Manitoba Inflammatory Bowel Disease Cohort Study: a prospective longitudinal evaluation of the use of complementary and alternative medicine services and products. Gut. 2012 Apr;61(4):521-7. doi: 10.1136/gutjnl-2011-300219. Epub 2011 Aug 11.
- Gupta SC, Kismali G, Aggarwal BB. Curcumin, a component of turmeric: from farm to pharmacy. Biofactors. 2013 Jan-Feb;39(1):2-13. doi: 10.1002/biof.1079. Epub 2013 Jan 22.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Gastrointestinal Diseases
- Gastroenteritis
- Colonic Diseases
- Intestinal Diseases
- Inflammatory Bowel Diseases
- Ulcer
- Colitis
- Colitis, Ulcerative
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Curcumin
Other Study ID Numbers
- CUR2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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