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NCT Number: NCT01320436

Curcumin + Aminosalicylic Acid (5ASA) Versus 5ASA Alone in the Treatment of Mild to Moderate Ulcerative Colitis

Ulcerative colitis (UC) is a chronic inflammatory disease resulting in increased morbidity in patients. The current standard treatment for mild to moderate UC (MTMUC) includes 5-aminosalicylic compounds (5ASA) such as olsalazine and mesalamine, yet some patients continue to experience disease symptoms and flare-ups. These patients require higher dosages of 5ASA medications and in many cases escalate to steroid and/or immunosuppressant therapy which comprises higher risk of hazardous side effects.

Curcumin, an active ingredient of the Indian herb Rhizoma Curcuma Longa, has been extensively studied in the context of inflammatory diseases. In humans, a controlled study using curcumin as an adjusted therapy to 5ASA medication has shown it to be superior to placebo in maintaining remission in MTMUC patients . A small, preliminary open label study has also shown efficacy in reducing disease symptoms and inflammatory markers in this group of patients .

This data provides bases for investigating an integrative approach to optimize the current standard treatment in MTMUC patients. We speculate that using a combined therapy of 5ASA medication and curcumin could benefit this subgroup of patients and reduce morbidity and perhaps need for escalating pharmacological intervention.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sheba Medical Center

Ramat Gan, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of UC as confirmed by endoscopic or histologic criteria as established by RomeIII
  • Disease activity score of >5 and ≤13 according to the Simple clinical colitis activity index (SCCAI)
  • Patient on stable 5 ASA medication dose for at least 4 weeks prior to inclusion
  • Patients who receive immunosuppressant or biological therapy (azathioprine, 6-mercaptopurine, infliximab or methotrexate) must be on stable dose for at least 3 months prior to inclusion
  • Patients who receive topical therapy (5ASA or steroidal), must be on stable dose for a least 2 weeks prior to inclusion
  • Patient had hemoglobin of >10 g/dl.
  • Able and willing to give written consent

Exclusion criteria

  • Patient with renal or liver disease, sever cardiovascular disease, chronic pancreatitis, diabetes mellitus or gallstone.
  • Patient with laboratory abnormalities indicating anemia (hemoglobin <10), leucopenia, thrombocytopenia, abnormal coagulation.
  • Patient with infection, sepsis or pneumonia.
  • Pregnant or nursing women.
  • Unable or unwilling to receive CURCUMIN therapy.

Treatment and study plan

Curcumin

Dietary Supplement

3 capsules (820 mg containig 500 mg curcumin each) twice daily.

5-aminosalicylic acid

Drug

The dosage of 5ASA medication will be the maximum dosage given in this group of patients according to clinical guidelines (4gr' per os + topical 1gr mesalamine

Other names: Pentasa, Asacol, Rafasal, Mesalamine.

Primary outcomes

  1. The percentage of patients who achieve clinical remission compared between the two study arms.

    Time frame: 4 weeks

    The percentage of patients who achieve clinical remission compared between the two study arms at week 4 after induction of therapy. Clinical remission is defined as score of ≤2 in the Simple Clinical Colitis Activity Index (SCCAI) .

Secondary outcomes

  1. Time to response

    Time frame: 4 weeks

    Time to response (TTR) compared between study and control groups. Response is defined as remission or significant improvement. TTR is defined by number of days to achieve clinical response.

  2. significant improvement

    Time frame: 4 weeks

    Percentage of patients that show significant improvement (drop of ≥3 points in SCCAI) compared between the two study arms at week 4 after induction of therapy.

  3. serologic markers

    Time frame: 4 weeks

    Improvement in serologic parameters according to Seo index

  4. Percentage of patient on corticosteroids or anti TNF treatment

    Time frame: 4 weeks

  5. improvement in endoscopic score

    Time frame: 4 weeks

    Improvement in endoscopic score compared to inclusion day (in subgroup of patients)

  6. Improvement in IBD questionnaire (IBDQ).

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Registry information

Official study title

Randomized, Double-blind, Placebo-controlled Study to Evaluated the Efficacy of Combining Curcumin+5ASA Medication Versus 5ASA Medication Alone on Active Mild to Moderate Ulcerative Colitis Patients

Acronym: 5ASA

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Mar 22, 2011
Registry last updated
Feb 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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