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

Asian Institute of Gastroenterology, India

Status and phase: Unknown; Phase 3

Conditions: Ulcerative Colitis

Treatments: Drug: 5-Aminosalicyclic acid; Dietary Supplement: Bio-enhanced Curcumin Soft Gelatin Capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT02683759

AIGINDIACurcumin2

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

Treatment Arm

Active Comparator group

Description:

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:

Treatment:

Dietary Supplement: Bio-enhanced Curcumin Soft Gelatin Capsule

Drug: 5-Aminosalicyclic acid

Control Arm

Placebo Comparator group

Description:

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

Treatment:

Drug: 5-Aminosalicyclic acid