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

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

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.

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• 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

Contacts and Locations

Contacts

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

Locations

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

• Principal Investigator: Rupa Banerjee, MD, DM; Asian Institutes of Gastroenterology

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Rupa Banerjee, Consultant Gastroenterologist; Director, IBD Clinic, Asian Institute of Gastroenterology, India
• ClinicalTrials.gov Identifier: NCT02683733
• Other Study ID Numbers: AIGINDIACurcumin1
• First Posted: February 17, 2016
• 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:

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