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

This study is currently recruiting participants.
Verified July 2011 by Sheba Medical Center
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01320436
First received: March 21, 2011
Last updated: July 17, 2011
Last verified: July 2011
History of Changes
  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:

U.S. FDA Resources

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.


Estimated Enrollment: 50
Study Start Date: July 2011
Estimated Primary Completion Date: April 2012 (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 (820mg each) curcumin twice daily after meals.
 Dietary Supplement: Curcumin
3 capsules (820gr each) twice daily.
Drug: 5-aminosalicylic acid
Dose will be individually assigned according to treating physician's advise. Dose range will be 2-4 gr a day.
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
Dose will be individually assigned according to treating physician's advise. Dose range will be 2-4 gr a day.
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 medication dose for at least 4 weeks prior to inclusion
  • Patient had hemoglobin of >10 g/dl.
  • Able and willing to give written consent

Exclusion Criteria:

  • Patient receiving immunomodulator therapy like azathioprine, 6-mercaptopurine or cyclosporine.
  • 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 CC therapy.
  • Patients with proctitis.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01320436

Contacts
Contact: Alon Lang, MD 0543133413
Contact: Nir Salomon, C.Ac 0543010272 nironsl@gmail.com

Locations
Israel
Sheba Medical Center Recruiting
Ramat Gan, Israel
Contact: Nir Salomon, C.Ac     054-3010272     nironsl@gmail.com    
Principal Investigator: Alon Lang, MD            
Sub-Investigator: Nir Salomon, C.Ac            
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

No publications provided

Responsible Party: Dr Alon Lang, 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: July 17, 2011
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
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes
Aminosalicylic Acid
Curcumin
Mesalamine
Antitubercular Agents
Anti-Bacterial Agents
 Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
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
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013