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Ulcerative Colitis in RemissionNCT03122613

Curcumin for Prevention of Relapse in Patients With Ulcerative Colitis

A study testing Curcumin in people with Ulcerative Colitis in Remission, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ulcerative Colitis in Remission
What is being tested?
Curcumin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
29 participants
Where
1 siteHong Kong
Study dates
19 Jun 2017to 22 May 2020
Phase
Interventional
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • pregnancy or lactating women
  • with a Mayo endoscopic subscore ≥2 on sigmoidoscopy or colonoscopy at baseline
  • allergic to curry-related products

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site
  • Prince of Wales Hospital

    Hong Kong, 0000

Other trials in Hong Kong

About this study

Official title: 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).

Read the 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).

Being tested
Curcumin, Placebo

What participants receive

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

  • CurcuminDietary supplement

    Also called Turmeric

    3g of Curcumin per day

  • PlaceboDrug

    Also called Curcumin placebo

    3g of Curcumin Placebo per day

Study groups in NCT03122613
Study groupRoleWhat they receive
CurcuminActive comparatorDietary supplements of Curcumin capsules
Receives: Dietary Supplement: Curcumin
Curcumin PlaceboPlacebo comparatorIdentical looking placebo of the active arm
Receives: Drug: Placebo

What is being measured

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

  1. The relapse rate at 12 months

    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).

    Measured: 1 year

Secondary outcomes (8)
  1. Adverse events

    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

    Measured: 1 year

  2. Endoscopic remission

    Defined as a mayo endoscopic subscore of 0 or 1

    Measured: 1 year

  3. Simple Clinical Colitis Activity Index (SCCAI)

    compare the scores in two groups

    Measured: 1 year

  4. Fecal calprotectin levels at 12 months

    compare the difference of the levels between groups

    Measured: 1 year

  5. Fecal immunochemical test (FIT) at 12 months

    compare the positivity rate in those with flare

    Measured: 1 year

  6. Quality of Life assessed by the Inflammatory Bowel Disease Questionnaire (IBDQ)

    compare the scores in two groups

    Measured: 1 year

  7. Patient Reported Outcomes (PRO) Questionnaire

    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

    Measured: 1 year

  8. Pharmacokinetics study to measure the drug concentration-time courses

    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.

    Measured: 1 year

Timeline

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

  1. First posted21 Apr 2017
  2. Study start19 Jun 2017
  3. Primary completion22 May 2020
  4. Study completion22 May 2020

Why it stopped: Decision made by team of investigators

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03122613
Sponsor's protocol ID
CUR2
Status last verified
Oct 2022
First submitted
7 Apr 2017
Last updated
17 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23040451
  • 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.

    PubMed 23076890
  • 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.

    PubMed 12543288
  • 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.

    PubMed 11693328
  • 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.

    PubMed 12873575
  • 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.

    PubMed 15573925
  • 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.

    PubMed 25488896
  • 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.

    PubMed 20848543
  • 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.

    PubMed 21836028
  • 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.

    PubMed 23339055
  • 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.

    PubMed 25521115

Questions about this trial

What is this clinical trial studying?

A study testing Curcumin in people with Ulcerative Colitis in Remission, run by Chinese University of Hong Kong at 1 site in Hong Kong.

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 4 inclusion and 9 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: stopped early, as of the sponsor's last update on 17 Oct 2022. 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 Hong Kong. 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. Some participants in this study may receive a placebo. 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?

The study was stopped early (reason given: Decision made by team of investigators). Results are not available in the source record.

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?

The relapse rate at 12 months (time frame: 1 year). 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 NCT03122613, 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 17 Oct 2022.

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