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

Ulcerative Colitis Clinical Trial

— 5ASA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01320436
• Other study ID #: SHEBA-10-8356-AL-CTIL
• Status: Completed
• Phase: Phase 3
• First received: March 21, 2011
• Last updated: February 11, 2016
• Start date: July 2011
• Est. completion date: October 2014

Study information

• Verified date: February 2016
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

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

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of patients who achieve clinical remission compared between the two study arms.	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) .	4 weeks	No
Secondary	Time to response	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.	4 weeks	No
Secondary	significant improvement	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.	4 weeks	No
Secondary	serologic markers	Improvement in serologic parameters according to Seo index	4 weeks	No
Secondary	Percentage of patient on corticosteroids or anti TNF treatment		4 weeks	No
Secondary	improvement in endoscopic score	Improvement in endoscopic score compared to inclusion day (in subgroup of patients)	4 weeks	No
Secondary	Improvement in IBD questionnaire (IBDQ).		4 weeks	No