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

Ulcerative Colitis Clinical Trial

Official title:

The Efficacy and Tolerability of Bio-Enhanced Curcumin in Maintaining Remission in Patients With Ulcerative Colitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02683759
• Other study ID #: AIGINDIACurcumin2
• Status: Recruiting
• Phase: Phase 3
• First received: February 10, 2016
• Last updated: February 20, 2016
• Start date: February 2016

Study information

• Verified date: February 2016
• Source: Asian Institute of Gastroenterology, India
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

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) 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

Drug:
• 5-Aminosalicyclic acid
Dosage is as instructed by patient's physician

Locations

Country	Name	City	State
India	Asian Institutes of Gastroenterology	Hyderabad	Telangana

Sponsors (1)

Lead Sponsor	Collaborator
Asian Institute of Gastroenterology, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical remission is recorded by a Partial Mayo Index score of 0-1	1 year	No
Primary	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	Endoscopic remission is defined as endoscopic mucosal healing, is recorded by a Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score of <3	1 year	No
Secondary	Percentage of patients in the treatment arm who experienced adverse events as compared with patients in the placebo arm		1 year	No