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Bio-enhanced Curcumin as an Add-On Treatment in Mild to Moderate 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-Aminosalicylic acid
Sponsored by
Asian Institute of Gastroenterology, India
About
Eligibility
Locations
Arms
Outcomes
Full info

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 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

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-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

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

Outcomes

Primary Outcome Measures

Time to induction of clinical remission in the treatment arm compared with time to induction of clinical remission in control arm
Clinical remission is recorded by a Partial Mayo Index score of 0-1
Time to induction of endoscopic remission in the treatment arm compared with time to induction of endoscopic remission in control arm
Endoscopic remission is defined as endoscopic mucosal healing, is recorded by 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 control arm

Full Information

First Posted
February 10, 2016
Last Updated
February 20, 2016
Sponsor
Asian Institute of Gastroenterology, India
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1. Study Identification

Unique Protocol Identification Number
NCT02683733
Brief Title
Bio-enhanced Curcumin as an Add-On Treatment in Mild to Moderate Ulcerative Colitis
Official Title
The Efficacy and Tolerability of Bio-enhanced Curcumin (Diferuloylmethane) in the Induction of Remission in Patients With Mild to Moderate 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-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
Arm Title
Control Arm
Arm Type
Placebo Comparator
Arm Description
Patients will receive 5-Aminosalicylic 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)
Intervention Type
Drug
Intervention Name(s)
5-Aminosalicylic acid
Other Intervention Name(s)
5-ASA
Intervention Description
Dosage is as instructed by patient's physician
Primary Outcome Measure Information:
Title
Time to induction of clinical remission in the treatment arm compared with time to induction of clinical remission in control arm
Description
Clinical remission is recorded by a Partial Mayo Index score of 0-1
Time Frame
1 year
Title
Time to induction of endoscopic remission in the treatment arm compared with time to induction of endoscopic remission in control arm
Description
Endoscopic remission is defined as endoscopic mucosal healing, is recorded by 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 control 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
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rupa Banerjee, MD, DM
Email
dr_rupa_banerjee@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rupa Banerjee, MD, DM
Organizational Affiliation
Asian Institutes 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
Email
dr_rupa_banerjee@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32889959
Citation
Banerjee R, Pal P, Penmetsa A, Kathi P, Girish G, Goren I, Reddy DN. Novel Bioenhanced Curcumin With Mesalamine for Induction of Clinical and Endoscopic Remission in Mild-to-Moderate Ulcerative Colitis: A Randomized Double-Blind Placebo-controlled Pilot Study. J Clin Gastroenterol. 2021 Sep 1;55(8):702-708. doi: 10.1097/MCG.0000000000001416.
Results Reference
derived

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

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