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

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ClinicalTrials.gov Identifier: NCT02683733
Recruitment Status : Unknown
Verified February 2016 by Rupa Banerjee, Asian Institute of Gastroenterology, India.
Recruitment status was:  Recruiting
First Posted : February 17, 2016
Last Update Posted : February 23, 2016
Sponsor:
Information provided by (Responsible Party):
Rupa Banerjee, Asian Institute of Gastroenterology, India

Tracking Information
First Submitted Date  ICMJE February 10, 2016
First Posted Date  ICMJE February 17, 2016
Last Update Posted Date February 23, 2016
Study Start Date  ICMJE February 2016
Estimated Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2016)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02683733 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2016)
Percentage of patients in the treatment arm who experienced adverse events as compared with patients in the control arm [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bio-enhanced Curcumin as an Add-On Treatment in Mild to Moderate Ulcerative Colitis
Official Title  ICMJE The Efficacy and Tolerability of Bio-enhanced Curcumin (Diferuloylmethane) in the Induction of Remission in Patients With Mild to Moderate Ulcerative Colitis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE
  • 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 Name: Valdone
  • Drug: 5-Aminosalicylic acid
    Dosage is as instructed by patient's physician
    Other Name: 5-ASA
Study Arms  ICMJE
  • 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

    Interventions:
    • Dietary Supplement: Bio-enhanced Curcumin Soft Gelatin Capsule
    • Drug: 5-Aminosalicylic acid
  • 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
    Intervention: Drug: 5-Aminosalicylic acid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 12, 2016)
50
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02683733
Other Study ID Numbers  ICMJE AIGINDIACurcumin1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rupa Banerjee, Asian Institute of Gastroenterology, India
Study Sponsor  ICMJE Asian Institute of Gastroenterology, India
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rupa Banerjee, MD, DM Asian Institutes of Gastroenterology
PRS Account Asian Institute of Gastroenterology, India
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP