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

History of Changes

Tracking Information
First Received Date ^ICMJE	November 6, 2009
Last Updated Date	November 9, 2009
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study of Chicory for Treatment of Osteoarthritis of the Hip or Knee
Official Title ^ICMJE	A Phase I Study of Chicory for Treatment of Osteoarthritis of the Hip or Knee
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Not Provided
Condition ^ICMJE	Osteoarthritis
Intervention ^ICMJE	Dietary Supplement: Chicory root extract
Study Arm (s)	Not Provided
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	50 Years and older (Adult, Senior)
Accepts Healthy Volunteers	Not Provided
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ^ICMJE	Not Provided
Removed Location Countries

Administrative Information
NCT Number ^ICMJE	NCT01010919
Other Study ID Numbers ^ICMJE	PMI-005-01
Has Data Monitoring Committee	Not Provided
Plan to Share Data	Not Provided
IPD Description	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Phytomedics Inc.
Collaborators ^ICMJE	University of Texas, Southwestern Medical Center at Dallas
Investigators ^ICMJE	Not Provided
Information Provided By	Phytomedics Inc.
Verification Date	November 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top