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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01010919
• Other study ID #: PMI-005-01
• Status: Completed
• Phase: Phase 1
• First received: November 6, 2009
• Last updated: November 9, 2009

Study information

• Verified date: November 2009
• Source: Phytomedics Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

1. Patients must be 50 years of age or older and may be of either gender.

2. Patients must have have an imaging-confirmed (radiograph or MRI) diagnosis of OA of the hip or knee.

3. 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).

4. Patients must be able and willing to give informed consent.

Exclusion Criteria:

1. Any unstable comorbid medical condition that in the opinion of the investigator could interfere with the ability of the patient to complete the study.

2. 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.

3. Patients requiring continuing therapy with nonsteroidal anti-inflammatory drugs are excluded.

4. Patients requiring any dose of glucocorticoids within the past 30 days are excluded.

Study Design

N/A

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Dietary Supplement:
• Chicory root extract

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Phytomedics Inc.	University of Texas, Southwestern Medical Center at Dallas