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

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ClinicalTrials.gov Identifier: NCT02683759
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

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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Dietary Supplement: Bio-enhanced Curcumin Soft Gelatin Capsule Drug: 5-Aminosalicyclic acid Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Efficacy and Tolerability of Bio-Enhanced Curcumin in Maintaining Remission in Patients With Ulcerative Colitis
Study Start Date : February 2016
Estimated Primary Completion Date : February 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Curcumin

Arm Intervention/treatment
Active Comparator: Treatment Arm
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:
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)

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

Other Name: Valdone

Drug: 5-Aminosalicyclic acid
Dosage is as instructed by patient's physician
Other Name: 5-ASA

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




Primary Outcome Measures :
  1. 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 [ Time Frame: 1 year ]
    Clinical remission is recorded by a Partial Mayo Index score of 0-1

  2. 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 [ Time Frame: 1 year ]
    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 :
  1. Percentage of patients in the treatment arm who experienced adverse events as compared with patients in the placebo arm [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02683759


Locations
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India
Asian Institutes of Gastroenterology Recruiting
Hyderabad, Telangana, India
Contact: Rupa Banerjee, MD, DM       dr_rupa_banerjee@hotmail.com   
Sponsors and Collaborators
Asian Institute of Gastroenterology, India
Investigators
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Principal Investigator: Rupa Banerjee, MD, DM Asian Institute of Gastroenterology

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Responsible Party: Rupa Banerjee, Consultant Gastroenterologisy, Asian Institute of Gastroenterology, India
ClinicalTrials.gov Identifier: NCT02683759     History of Changes
Other Study ID Numbers: AIGINDIACurcumin2
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: February 23, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action