A Study of Chicory for Treatment of Osteoarthritis of the Hip or Knee

NCT01010919 | Completed Phase 1

• 1 other identifier: PMI-005-01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Extracts of chicory root have anti-inflammatory properties in vitro and in animal models of arthritis. The primary objective of this investigator-initiated, Phase 1, placebo-controlled, double blind, dose-escalating trial is to determine the safety and tolerability of a proprietary bioactive extract of chicory root in patients with osteoarthritis (OA). Secondary objectives are to assess effects on the signs and symptoms of this disorder. Individuals greater than 50 years of age with OA of the hip or knee will be eligible for trial entry.

Conditions

Osteoarthritis

Interventions

Chicory root extract DIETARY_SUPPLEMENT

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be 50 years of age or older and may be of either gender.
• Patients must have have an imaging-confirmed (radiograph or MRI) diagnosis of OA of the hip or knee.
• Patients must not have taken a nonsteroidal anti-inflammatory medication for at least 7 days prior to the baseline visit (a single daily aspirin 325 mg or less is allowed throughout the study).
• Patients must be able and willing to give informed consent.

You may not qualify if:

• Any unstable comorbid medical condition that in the opinion of the investigator could interfere with the ability of the patient to complete the study.
• Patients who are unable to ambulate and require a wheelchair due to the severity of the arthritis are excluded. Ambulatory aids such as canes and walkers are acceptable.
• Patients requiring continuing therapy with nonsteroidal anti-inflammatory drugs are excluded.
• Patients requiring any dose of glucocorticoids within the past 30 days are excluded.

Sponsors & Collaborators

• Phytomedics Inc.: lead
• University of Texas, Southwestern Medical Center at Dallas: collaborator

Related Publications (1)

• Olsen NJ, Branch VK, Jonnala G, Seskar M, Cooper M. Phase 1, placebo-controlled, dose escalation trial of chicory root extract in patients with osteoarthritis of the hip or knee. BMC Musculoskelet Disord. 2010 Jul 9;11:156. doi: 10.1186/1471-2474-11-156.

  PMID: 20618964 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 6, 2009
• First Posted: November 10, 2009
• Last Updated: November 10, 2009

Record last verified: 2009-11