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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01010919
Recruitment Status : Completed
First Posted : November 10, 2009
Last Update Posted : November 10, 2009
University of Texas, Southwestern Medical Center at Dallas
Information provided by:
Phytomedics Inc.

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Dietary Supplement: Chicory root extract Phase 1

Study Type : Interventional  (Clinical Trial)
Official Title: A Phase I Study of Chicory for Treatment of Osteoarthritis of the Hip or Knee

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

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.

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT01010919     History of Changes
Other Study ID Numbers: PMI-005-01
First Posted: November 10, 2009    Key Record Dates
Last Update Posted: November 10, 2009
Last Verified: November 2009

Additional relevant MeSH terms:
Osteoarthritis, Hip
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases