Bio-enhanced Curcumin as an Add-On Treatment in Mild to Moderate Ulcerative Colitis

February 20, 2016 updated by: Rupa Banerjee, Asian Institute of Gastroenterology, India

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment Arm

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
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
Placebo Comparator: Control Arm
Patients will receive 5-Aminosalicylic acid as per their current treatment regimen and will also take a placebo pill twice daily after meals
Drug: 5-Aminosalicylic acid
Dosage is as instructed by patient's physician
Other Names:
  • 5-ASA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to induction of clinical remission in the treatment arm compared with time to induction of clinical remission in control arm
Time Frame: 1 year
Clinical remission is recorded by a Partial Mayo Index score of 0-1
1 year
Time to induction of endoscopic remission in the treatment arm compared with time to induction of endoscopic remission in control arm
Time Frame: 1 year
Endoscopic remission is defined as endoscopic mucosal healing, is recorded by Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score of <3
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients in the treatment arm who experienced adverse events as compared with patients in the control arm
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asian Institute of Gastroenterology, India

Investigators

  • Principal Investigator: Rupa Banerjee, MD, DM, Asian Institutes of Gastroenterology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Anticipated)

February 1, 2017

Study Registration Dates

First Submitted

February 10, 2016

First Submitted That Met QC Criteria

February 12, 2016

First Posted (Estimate)

February 17, 2016

Study Record Updates

Last Update Posted (Estimate)

February 23, 2016

Last Update Submitted That Met QC Criteria

February 20, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIGINDIACurcumin1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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