Bio-enhanced Curcumin as an Add-on Treatment in Maintaining Remission of Ulcerative Colitis

NCT ID: NCT02683759

Last Updated: 2016-02-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29

Brief Summary

Inflammatory Bowel Disease, including ulcerative colitis, is thought to result from an imbalance of pro-inflammatory and anti-inflammatory factors. As such, the majority of treatment options are directed at attempting to control the chronic inflammation and prolonging remission of clinical symptoms. Several studies have proven that curcumin has well-established anti-inflammatory properties. However, curcumin has poor bioavailability and prior studies have needed to use high concentrations in order to study the efficacy of the product. The investigators propose that a bio-enhanced preparation of curcumin will require a lower dosage to reach and affect its target tissue and will subsequently produce less adverse side effects.

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Treatment Arm

Patients will receive 5-Aminosalicyclic acid as per their current treatment regimen and will also take Bio-enhanced curcumin twice daily after meals as per the following regimen:

Group Type: ACTIVE_COMPARATOR

Bio-enhanced Curcumin Soft Gelatin Capsule

Intervention Type: DIETARY_SUPPLEMENT

Each capsule is a bio-enhanced modification of curcumin (diferuloylmethane), which is a derivative of curcuma longa (rhizome extract)

Starting dose: 50 mg BID of Bioenhanced Curcumin Increase dose to 100 mg BID after two (2) weeks if there is no response to the drug

5-Aminosalicyclic acid

Intervention Type: DRUG

Dosage is as instructed by patient's physician

Control Arm

Patients will receive 5-Aminosalicyclic acid as per their current treatment regimen and will also take a placebo pill twice daily after meals

Group Type: PLACEBO_COMPARATOR

5-Aminosalicyclic acid

Intervention Type: DRUG

Dosage is as instructed by patient's physician

Interventions

Bio-enhanced Curcumin Soft Gelatin Capsule

Each capsule is a bio-enhanced modification of curcumin (diferuloylmethane), which is a derivative of curcuma longa (rhizome extract)

Starting dose: 50 mg BID of Bioenhanced Curcumin Increase dose to 100 mg BID after two (2) weeks if there is no response to the drug

Intervention Type: DIETARY_SUPPLEMENT

5-Aminosalicyclic acid

Dosage is as instructed by patient's physician

Intervention Type: DRUG

Other Intervention Names

Valdone; 5-ASA

Eligibility Criteria

Inclusion Criteria

• Patients who have been in symptomatic remission from Ulcerative Colitis for at least 3 months. This is defined as a Partial Mayo Index Score of 0 or 1
• Age 18 years and above
• Male or female
• Patients who are able and willing to follow the treatment given and record responses in survey form

Exclusion Criteria

• Patients who are currently experiencing symptomatic flares of mild or moderate ulcerative colitis, or have a partial mayo index score of 2 or greater
• Patients who have been taking azathioprine or mercaptopurine for <12 weeks for the treatment of their ulcerative colitis
• Patients who are taking steroids, immunosuppressants, or biologic agents for the treatment of their ulcerative colitis
• Patients who have severe ulcerative colitis
• Patients who are noncompliant with medication or regular follow up visits
• Patients who are unable or unwilling to record their responses in survey form
• Patients with comorbid illnesses, including: Diabetes Mellitus, Stage III or above Congestive Heart Failure, chronic pancreatitis, severe liver or renal disease
• Patients who have current gallstones or biliary dysfunction
• Patients with anemia (Hemoglobin <10), thrombocytopenia, abnormal lymphocyte counts, or coagulation abnormalities
• Patients with current sepsis or current ongoing infection, including C. difficile colitis or enteritis
• Patients with a history of malignancy
• Patients who are currently pregnant or nursing
• Patients who are current smokers

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asian Institute of Gastroenterology, India

OTHER

Sponsor Role: lead

Responsible Party

Rupa Banerjee

Consultant Gastroenterologisy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rupa Banerjee, MD, DM

Role: PRINCIPAL_INVESTIGATOR

Asian Institute of Gastroenterology

Locations

Asian Institutes of Gastroenterology

Hyderabad, Telangana, India

Site Status: RECRUITING

Countries

India

Facility Contacts

Rupa Banerjee, MD, DM

Role: primary

dr_rupa_banerjee@hotmail.com

Other Identifiers

AIGINDIACurcumin2

Identifier Type: -

Identifier Source: org_study_id