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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Alon Lang, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01320436
First received: March 21, 2011
Last updated: February 11, 2016
Last verified: February 2016
  Purpose

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.


Condition Intervention Phase
Ulcerative Colitis
Dietary Supplement: Curcumin
Drug: 5-aminosalicylic acid
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • The percentage of patients who achieve clinical remission compared between the two study arms. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Time to response [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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.

  • significant improvement [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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.

  • serologic markers [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Improvement in serologic parameters according to Seo index

  • Percentage of patient on corticosteroids or anti TNF treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • improvement in endoscopic score [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Improvement in endoscopic score compared to inclusion day (in subgroup of patients)

  • Improvement in IBD questionnaire (IBDQ). [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: July 2011
Study Completion Date: October 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatments arm
Patients allocated for this arm will receive 5ASA medication (as advised by their treating physician) + 3 capsules (total of 820 mg each,containing 500 mg curcumin ) curcumin twice daily after meals.
Dietary Supplement: Curcumin
3 capsules (820 mg containig 500 mg curcumin each) twice daily.
Drug: 5-aminosalicylic acid
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 Name: Pentasa, Asacol, Rafasal, Mesalamine.
Placebo Comparator: Control arm
Patients allocated to this arm will receive 5ASA medication (as advised by their treating physician) + 3 capsules (820gr each) of placebo twice a day after meals.
Drug: 5-aminosalicylic acid
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 Name: Pentasa, Asacol, Rafasal, Mesalamine.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01320436

Locations
Israel
Sheba Medical Center
Ramat Gan, Israel
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Alon Lang, MD Sheba Medical Center
Principal Investigator: Nir Salomon, C.Ac Sheba Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Alon Lang, MD, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01320436     History of Changes
Other Study ID Numbers: SHEBA-10-8356-AL-CTIL 
Study First Received: March 21, 2011
Last Updated: February 11, 2016
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
Ulcerative colitis
Curcumin

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Colonic Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Pathologic Processes
Aminosalicylic Acid
Curcumin
Mesalamine
Analgesics
Analgesics, Non-Narcotic
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antineoplastic Agents
Antirheumatic Agents
Antitubercular Agents
Central Nervous System Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 01, 2016