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Trial record 5 of 162 for:    curcumin

Curcumin for Prevention of Relapse in Patients With Ulcerative Colitis

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ClinicalTrials.gov Identifier: NCT03122613
Recruitment Status : Recruiting
First Posted : April 21, 2017
Last Update Posted : October 2, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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. 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).


Condition or disease Intervention/treatment
Ulcerative Colitis in Remission Dietary Supplement: Curcumin Drug: Placebo

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double-blinded using identical looking products in both arms
Primary Purpose: Other
Official Title: A Double-blind, Randomized, Placebo-Controlled Trial of Curcumin Versus Placebo for Prevention of Relapse in Patients With Ulcerative Colitis
Actual Study Start Date : June 19, 2017
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Curcumin
Dietary supplements of Curcumin capsules
Dietary Supplement: Curcumin
3g of Curcumin per day
Other Name: Turmeric
Placebo Comparator: Curcumin Placebo
Identical looking placebo of the active arm
Drug: Placebo
3g of Curcumin Placebo per day
Other Name: Curcumin placebo


Outcome Measures

Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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


  2. Endoscopic remission [ Time Frame: 1 year ]
    Defined as a mayo endoscopic subscore of 0 or 1

  3. Simple Clinical Colitis Activity Index (SCCAI) [ Time Frame: 1 year ]
    compare the scores in two groups

  4. Fecal calprotectin levels at 12 months [ Time Frame: 1 year ]
    compare the difference of the levels between groups

  5. Fecal immunochemical test (FIT) at 12 months [ Time Frame: 1 year ]
    compare the positivity rate in those with flare

  6. Quality of Life assessed by the Inflammatory Bowel Disease Questionnaire (IBDQ) [ Time Frame: 1 year ]
    compare the scores in two groups

  7. 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

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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • presence of previous colonic 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03122613


Contacts
Contact: Jessica CHING +852 35053524 jessicaching@cuhk.edu.hk
Contact: Kitty CHEUNG +852 26373260 kittyccy@cuhk.edu.hk

Locations
Hong Kong
Prince of Wales Hospital Recruiting
Hong Kong, Hong Kong, 0000
Contact: Siew Ng    (852)35051519    siewchienng@cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Siew Ng, Prof. Chinese University of Hong Kong
More Information

Publications:

Responsible Party: Siew Chien NG, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03122613     History of Changes
Other Study ID Numbers: CUR2
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: October 2, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Curcumin
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action