NCT02683759

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

The Efficacy and Tolerability of Bio-Enhanced Curcumin in Maintaining Remission in Patients With Ulcerative Colitis

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Asian Institute of Gastroenterology, India · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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
DRUG	5-Aminosalicyclic acid	Dosage is as instructed by patient's physician

Timeline

• Start date: 2016-02-01
• Primary completion: 2017-02-01
• First posted: 2016-02-17
• Last updated: 2016-02-23

Locations

1 site across 1 country: India