A Study of Chicory for Treatment of Osteoarthritis of the Hip or Knee
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01010919 |
Recruitment Status
:
Completed
First Posted
: November 10, 2009
Last Update Posted
: November 10, 2009
|
Sponsor:
Phytomedics Inc.
Collaborator:
University of Texas, Southwestern Medical Center at Dallas
Information provided by:
Phytomedics Inc.
Tracking Information | |||
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First Submitted Date ICMJE | November 6, 2009 | ||
First Posted Date ICMJE | November 10, 2009 | ||
Last Update Posted Date | November 10, 2009 | ||
Study 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 Arms | 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. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Enrollment ICMJE | Not Provided | ||
Original Enrollment ICMJE | Not Provided | ||
Study Completion Date | Not Provided | ||
Primary Completion Date | Not Provided | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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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 | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | 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 | ||
PRS Account | Phytomedics Inc. | ||
Verification Date | November 2009 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |