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

NCT02683759 | Unknown Phase 3 DMC

• 1 other identifier: AIGINDIACurcumin2
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (1)

• Percentage of patients in the treatment arm who experienced adverse events as compared with patients in the placebo arm

  1 year

Study Arms (2)

Treatment Arm

ACTIVE COMPARATOR

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:

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

Control Arm

PLACEBO COMPARATOR

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

Drug: 5-Aminosalicyclic acid

Interventions

Bio-enhanced Curcumin Soft Gelatin Capsule 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

Also known as: Valdone

Treatment Arm

5-Aminosalicyclic acid DRUG

Dosage is as instructed by patient's physician

Also known as: 5-ASA

Control Arm; Treatment Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

Asian Institutes of Gastroenterology

Hyderabad, Telangana, India

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Rupa Banerjee, MD, DM

  Asian Institute of Gastroenterology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Gastroenterologisy

Study Record Dates

• First Submitted: February 10, 2016
• First Posted: February 17, 2016
• Study Start: February 1, 2016
• Primary Completion: February 1, 2017
• Last Updated: February 23, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)