NCT02683733

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 17, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Last Updated

February 23, 2016

Status Verified

February 1, 2016

Enrollment Period

1 year

First QC Date

February 10, 2016

Last Update Submit

February 20, 2016

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (2)

  • 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

    1 year

  • 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

    1 year

Secondary Outcomes (1)

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

    1 year

Study Arms (2)

Treatment Arm

ACTIVE COMPARATOR

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 CapsuleDrug: 5-Aminosalicylic acid

Control Arm

PLACEBO COMPARATOR

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

Interventions

Bio-enhanced Curcumin Soft Gelatin CapsuleDIETARY_SUPPLEMENT

Each capsule is a bio-enhanced modification of curcumin (diferuloylmethane), which is a derivative of curcuma longa (rhizome extract)

Also known as: Valdone
Treatment Arm
5-Aminosalicylic acidDRUG

Dosage is as instructed by patient's physician

Also known as: 5-ASA
Control ArmTreatment Arm

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asian Institutes of Gastroenterology

Hyderabad, Telangana, India

RECRUITING

Related Publications (1)

  • 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.

    PMID: 32889959DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Mesalamine

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

meta-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsAminosalicylic AcidsSalicylatesHydroxybenzoatesHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenols

Study Officials

  • Rupa Banerjee, MD, DM

    Asian Institutes of Gastroenterology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rupa Banerjee, MD, DM

CONTACT

dr_rupa_banerjee@hotmail.com

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 Gastroenterologist; Director, IBD Clinic

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)