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

NCT ID: NCT02683733

Last Updated: 2016-02-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29

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.

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Bio-enhanced Curcumin Soft Gelatin Capsule

Intervention Type: DIETARY_SUPPLEMENT

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

5-Aminosalicylic acid

Intervention Type: DRUG

Dosage is as instructed by patient's physician

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

Group Type: PLACEBO_COMPARATOR

5-Aminosalicylic acid

Intervention Type: DRUG

Dosage is as instructed by patient's physician

Interventions

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)

Intervention Type: DIETARY_SUPPLEMENT

5-Aminosalicylic acid

Dosage is as instructed by patient's physician

Intervention Type: DRUG

Other Intervention Names

Valdone; 5-ASA

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asian Institute of Gastroenterology, India

OTHER

Sponsor Role: lead

Responsible Party

Rupa Banerjee

Consultant Gastroenterologist; Director, IBD Clinic

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rupa Banerjee, MD, DM

Role: PRINCIPAL_INVESTIGATOR

Asian Institutes of Gastroenterology

Locations

Asian Institutes of Gastroenterology

Hyderabad, Telangana, India

Site Status: RECRUITING

Countries

India

Central Contacts

Rupa Banerjee, MD, DM

Role: CONTACT

dr_rupa_banerjee@hotmail.com

Facility Contacts

Rupa Banerjee, MD, DM

Role: primary

dr_rupa_banerjee@hotmail.com

References

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.

Reference Type: DERIVED

PMID: 32889959 (View on PubMed)

Other Identifiers

AIGINDIACurcumin1

Identifier Type: -

Identifier Source: org_study_id