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

NCT ID: NCT01010919

Last Updated: 2009-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis

Interventions

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Chicory root extract

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Texas, Southwestern Medical Center at Dallas

OTHER

Sponsor Role collaborator

Phytomedics Inc.

INDUSTRY

Sponsor Role lead

References

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Olsen NJ, Branch VK, Jonnala G, Seskar M, Cooper M. Phase 1, placebo-controlled, dose escalation trial of chicory root extract in patients with osteoarthritis of the hip or knee. BMC Musculoskelet Disord. 2010 Jul 9;11:156. doi: 10.1186/1471-2474-11-156.

Reference Type DERIVED
PMID: 20618964 (View on PubMed)

Other Identifiers

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PMI-005-01

Identifier Type: -

Identifier Source: org_study_id

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