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

November 6, 2009
November 9, 2009
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Complete list of historical versions of study NCT01010919 on ClinicalTrials.gov Archive Site
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A Study of Chicory for Treatment of Osteoarthritis of the Hip or Knee
A Phase I Study of Chicory for Treatment of Osteoarthritis of the Hip or Knee

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.

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Interventional
Phase 1
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Osteoarthritis
Dietary Supplement: Chicory root extract
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.
Both
50 Years and older
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Contact information is only displayed when the study is recruiting subjects
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NCT01010919
PMI-005-01
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Phytomedics Inc.
University of Texas, Southwestern Medical Center at Dallas
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Phytomedics Inc.
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP