Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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23 February 2016 |
Main ID: |
NCT01320436 |
Date of registration:
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21/03/2011 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Curcumin + Aminosalicylic Acid (5ASA) Versus 5ASA Alone in the Treatment of Mild to Moderate Ulcerative Colitis
5ASA |
Scientific title:
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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 |
Date of first enrolment:
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July 2011 |
Target sample size:
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50 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT01320436 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Israel
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Contacts
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Name:
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Alon Lang, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Sheba Medical Center |
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Name:
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Nir Salomon, C.Ac |
Address:
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Telephone:
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Email:
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Affiliation:
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Sheba Medical Center |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis
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Intervention(s)
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Drug: 5-aminosalicylic acid
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Dietary Supplement: Curcumin
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Primary Outcome(s)
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The percentage of patients who achieve clinical remission compared between the two study arms.
[Time Frame: 4 weeks]
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Secondary Outcome(s)
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Improvement in IBD questionnaire (IBDQ).
[Time Frame: 4 weeks]
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serologic markers
[Time Frame: 4 weeks]
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Percentage of patient on corticosteroids or anti TNF treatment
[Time Frame: 4 weeks]
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significant improvement
[Time Frame: 4 weeks]
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Time to response
[Time Frame: 4 weeks]
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improvement in endoscopic score
[Time Frame: 4 weeks]
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Secondary ID(s)
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SHEBA-10-8356-AL-CTIL
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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