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

NCT01320436 | Completed Phase 3

• 1 other identifier: SHEBA-10-8356-AL-CTIL
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis

Keywords

Ulcerative colitis; Curcumin

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Time to response

  4 weeks

• significant improvement

  4 weeks

• serologic markers

  4 weeks

• Percentage of patient on corticosteroids or anti TNF treatment

  4 weeks

• improvement in endoscopic score

  4 weeks

Study Arms (2)

Treatments arm

ACTIVE COMPARATOR

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.

Dietary Supplement: Curcumin; Drug: 5-aminosalicylic acid

Control arm

PLACEBO COMPARATOR

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

Interventions

Curcumin DIETARY_SUPPLEMENT

3 capsules (820 mg containig 500 mg curcumin each) twice daily.

Treatments arm

5-aminosalicylic acid DRUG

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

Also known as: Pentasa, Asacol, Rafasal, Mesalamine.

Control arm; Treatments arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 had hemoglobin of \>10 g/dl.
• Able and willing to give written consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

Location

Related Publications (1)

• Lang A, Salomon N, Wu JC, Kopylov U, Lahat A, Har-Noy O, Ching JY, Cheong PK, Avidan B, Gamus D, Kaimakliotis I, Eliakim R, Ng SC, Ben-Horin S. Curcumin in Combination With Mesalamine Induces Remission in Patients With Mild-to-Moderate Ulcerative Colitis in a Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2015 Aug;13(8):1444-9.e1. doi: 10.1016/j.cgh.2015.02.019. Epub 2015 Feb 24.

  PMID: 25724700 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Curcumin; Mesalamine

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids

Study Officials

• Alon Lang, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

• Nir Salomon, C.Ac

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 21, 2011
• First Posted: March 22, 2011
• Study Start: July 1, 2011
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2014
• Last Updated: February 12, 2016

Record last verified: 2016-02

Locations

IL (1)