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

Primary Purpose

Ulcerative Colitis

Status

Unknown status

Phase

Phase 3

Locations

India

Study Type

Interventional

Intervention

Bio-enhanced Curcumin Soft Gelatin Capsule

5-Aminosalicyclic acid

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Asian Institutes of GastroenterologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Treatment Arm

Control Arm

Arm Description

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:

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

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02683759

First Posted

February 10, 2016

Last Updated

February 20, 2016

Sponsor

Asian Institute of Gastroenterology, India

1. Study Identification

Unique Protocol Identification Number

NCT02683759

Brief Title

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

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Unknown status

Study Start Date

February 2016 (undefined)

Primary Completion Date

February 2017 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Asian Institute of Gastroenterology, India

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ulcerative Colitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment Arm

Arm Type

Active Comparator

Arm Description

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:

Arm Title

Control Arm

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Bio-enhanced Curcumin Soft Gelatin Capsule

Other Intervention Name(s)

Valdone

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

5-Aminosalicyclic acid

Other Intervention Name(s)

5-ASA

Intervention Description

Dosage is as instructed by patient's physician

Primary Outcome Measure Information:

Title

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

Description

Clinical remission is recorded by a Partial Mayo Index score of 0-1

Time Frame

1 year

Title

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

Description

Endoscopic remission is defined as endoscopic mucosal healing, is recorded by a Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score of <3

Time Frame

1 year

Secondary Outcome Measure Information:

Title

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

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rupa Banerjee, MD, DM

Organizational Affiliation

Asian Institute of Gastroenterology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Asian Institutes of Gastroenterology

City

Hyderabad

State/Province

Telangana

Country

India

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rupa Banerjee, MD, DM

dr_rupa_banerjee@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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