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

This study has been completed.
Sponsor:
Collaborator:
University of Texas, Southwestern Medical Center at Dallas
Information provided by:
Phytomedics Inc.
ClinicalTrials.gov Identifier:
NCT01010919
First received: November 6, 2009
Last updated: November 9, 2009
Last verified: November 2009
  Purpose

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 Intervention Phase
Osteoarthritis
Dietary Supplement: Chicory root extract
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Phytomedics Inc.:

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01010919     History of Changes
Other Study ID Numbers: PMI-005-01
Study First Received: November 6, 2009
Last Updated: November 9, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 28, 2014