NCT02543931

Curcuma Longa L in Rheumatoid Arthritis

Phase Ib Randomized, Double-Blind, Placebo-Controlled Study of Meriva in Rheumatoid Arthritis

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out whether turmeric dietary supplements that are available over the counter for general use in the United States are safe and useful when taken specifically for the treatment of rheumatoid arthritis (RA) and how the active principles in turmeric are broken down and metabolized by the body in individuals with RA.

Detailed description

A placebo-controlled, double-blind, three-arm Phase Ib clinical trial assessing two doses of a commercially available curcuminoid formulation with enhanced bioavailability vs. placebo in a rheumatoid arthritis (RA) population is proposed. The primary aim of this clinical planning study is to determine the dose-dependent tolerability of an enhanced bioavailability curcuminoid formulation in an RA population, including pharmacokinetic analyses, to inform the design of a future Phase II trial assessing the anti-inflammatory efficacy of curcuminoids in the treatment of RA. Secondarily, estimates of effect size for changes in known biomarkers of inflammation in RA will be determined.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Meriva	Meriva is an enhanced-bioavailability, curcuminoid-enriched turmeric dietary supplement that is sold over the counter in the United States and other countries.
DRUG	placebo	Placebo capsules containing inert ingredients

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-06-01
• Completion: 2017-09-01
• First posted: 2015-09-07
• Last updated: 2016-11-30

Locations

1 site across 1 country: United States