Ulcerative Colitis
Conditions
Keywords
Ulcerative colitis, Curcumin
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTCurcumin
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
Sponsors
Sheba Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The percentage of patients who achieve clinical remission compared between the two study arms. | 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
| Measure | Time frame | Description |
|---|---|---|
| significant improvement | 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. |
| serologic markers | 4 weeks | Improvement in serologic parameters according to Seo index |
| Time to response | 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. |
| improvement in endoscopic score | 4 weeks | Improvement in endoscopic score compared to inclusion day (in subgroup of patients) |
| Improvement in IBD questionnaire (IBDQ). | 4 weeks | — |
| Percentage of patient on corticosteroids or anti TNF treatment | 4 weeks | — |
Countries
Israel
Outcome results
None listed