- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01320436
Curcumin + Aminosalicylic Acid (5ASA) Versus 5ASA Alone in the Treatment of Mild to Moderate Ulcerative Colitis (5ASA)
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Ramat Gan, Israel
- Sheba Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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3 capsules (820 mg containig 500 mg curcumin each) twice daily.
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:
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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.
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The percentage of patients who achieve clinical remission compared between the two study arms.
Time Frame: 4 weeks
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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) .
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4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to response
Time Frame: 4 weeks
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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.
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4 weeks
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significant improvement
Time Frame: 4 weeks
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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.
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4 weeks
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serologic markers
Time Frame: 4 weeks
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Improvement in serologic parameters according to Seo index
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4 weeks
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Percentage of patient on corticosteroids or anti TNF treatment
Time Frame: 4 weeks
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4 weeks
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improvement in endoscopic score
Time Frame: 4 weeks
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Improvement in endoscopic score compared to inclusion day (in subgroup of patients)
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4 weeks
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Improvement in IBD questionnaire (IBDQ).
Time Frame: 4 weeks
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4 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alon Lang, MD, Sheba Medical Center
- Principal Investigator: Nir Salomon, C.Ac, Sheba Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Gastrointestinal Diseases
- Gastroenteritis
- Colonic Diseases
- Intestinal Diseases
- Inflammatory Bowel Diseases
- Ulcer
- Colitis
- Colitis, Ulcerative
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Anti-Bacterial Agents
- Antitubercular Agents
- Mesalamine
- Aminosalicylic Acid
- Curcumin
Other Study ID Numbers
- SHEBA-10-8356-AL-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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