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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

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-Aminosalicylic 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 (Diferuloylmethane) in the Induction of Remission in Patients With Mild to Moderate Ulcerative Colitis
Study Start Date : February 2016
Estimated Primary Completion Date : February 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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

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




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Percentage of patients in the treatment arm who experienced adverse events as compared with patients in the control 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 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

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): NCT02683733


Contacts
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Contact: Rupa Banerjee, MD, DM dr_rupa_banerjee@hotmail.com

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 Institutes of Gastroenterology

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Responsible Party: Rupa Banerjee, Consultant Gastroenterologist; Director, IBD Clinic, Asian Institute of Gastroenterology, India
ClinicalTrials.gov Identifier: NCT02683733     History of Changes
Other Study ID Numbers: AIGINDIACurcumin1
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
Aminosalicylic Acid
Curcumin
Mesalamine
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
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents