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

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Chicory root extract
Sponsored by
Phytomedics Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional trial for Osteoarthritis

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All Sexes

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    November 6, 2009
    Last Updated
    November 9, 2009
    Sponsor
    Phytomedics Inc.
    Collaborators
    University of Texas, Southwestern Medical Center at Dallas
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01010919
    Brief Title
    A Study of Chicory for Treatment of Osteoarthritis of the Hip or Knee
    Official Title
    A Phase I Study of Chicory for Treatment of Osteoarthritis of the Hip or Knee
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Phytomedics Inc.
    Collaborators
    University of Texas, Southwestern Medical Center at Dallas

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis

    7. Study Design

    Study Phase
    Phase 1

    8. Arms, Groups, and Interventions

    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Chicory root extract

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20618964
    Citation
    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.
    Results Reference
    derived

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

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