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OpenTrials
Completed

NCT Number: NCT01010919

A 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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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Chicory root extract

Dietary Supplement

Sponsors and collaborators

Lead sponsor

Phytomedics Inc.

Industry

Collaborators

  • University of Texas, Southwestern Medical Center at Dallas

Registry information

Official study title

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

Important dates

First posted
Nov 10, 2009
Registry last updated
Nov 10, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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