Clinical trial NCT02683759: Bio-enhanced Curcumin as an Add-on Treatment in Maintaining Remission of Ulcerative Colitis
Official title: The Efficacy and Tolerability of Bio-Enhanced Curcumin in Maintaining Remission in Patients With Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Ulcerative Colitis
Lead sponsor: Asian Institute of Gastroenterology, India
Sponsor class: OTHER
First posted: 2016-02-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of patients who remained in clinical remission in the treatment arm compared with percentage of patients who remained in clinical remission in the control arm
timeFrame: 1 year
measure: Percentage of patients who remained in endoscopic remission in the treatment arm compared with percentage of patients who remained in endoscopic remission in the control arm
timeFrame: 1 year
Secondary outcomes:
measure: Percentage of patients in the treatment arm who experienced adverse events as compared with patients in the placebo arm
timeFrame: 1 year
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Asian Institutes of Gastroenterology
state: Telangana
Study officials:
affiliation: Asian Institute of Gastroenterology
name: Rupa Banerjee, MD, DM
role: PRINCIPAL_INVESTIGATOR
References: