Trial | NCT02683733  Report issue

Title

Bio-enhanced Curcumin as an Add-On Treatment in Mild to Moderate Ulcerative Colitis
The Efficacy and Tolerability of Bio-enhanced Curcumin (Diferuloylmethane) in the Induction of Remission in Patients With Mild to Moderate Ulcerative Colitis

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    50
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.
Study Started
Feb 29
2016
Primary Completion
Feb 28
2017
Anticipated
Last Update
Feb 23
2016
Estimate

Dietary Supplement 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)

  • Other names: Valdone

Drug 5-Aminosalicylic acid

Dosage is as instructed by patient's physician

  • Other names: 5-ASA

Treatment Arm Active Comparator

Patients will receive 5-Aminosalicylic acid as per their current treatment regimen and will also take Bio-enhanced curcumin twice daily after meals as per the following regimen: Starting dose: 50 mg BID of Bio-enhanced Curcumin Soft Gelatin Capsule Increase dose to 100 mg BID after two (2) weeks if there is no response to the drug

Control Arm Placebo Comparator

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

Criteria 

Inclusion Criteria:

Patients who have mild to moderate ulcerative colitis, with a current Partial Mayo Index greater than or equal to 2 and less than or equal to 6
Age 18 years and above
Male or female
Patients who have given consent and area able to follow the treatment given
Patients who are able to record their responses in survey form at regular follow-up visits

Exclusion Criteria:

Patients who are in remission from ulcerative colitis, or who have a Partial Mayo Index Score of 0 or 1
Patients who have been taking azathioprine or mercaptopurine for <12 weeks for the treatment of their ulcerative colitis
Patients who are taking steroids or biologic agents for the treatment of their ulcerative colitis
Patients who have severe ulcerative colitis, or who have a Partial Mayo Index Score of 7 or above
Patients who are noncompliant with medication or regular follow up visits
Patients who are unable to 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 any biliary dysfunction
Patients with anemia (Hemoglobin <10), thrombocytopenia, abnormal lymphocyte counts, or coagulation abnormalities
Patients who currently have an ongoing severe infection/sepsis
Patients with a history of malignancy
Patients who are currently pregnant or nursing
Patients who are current smokers
No Results Posted