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Effect of Phytalgic in Osteoarthritis (OA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00666523
First Posted: April 25, 2008
Last Update Posted: April 25, 2008
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.
Collaborator:
laboratoire Phythea, France
Information provided by:
Université Victor Segalen Bordeaux 2
  Purpose
The objective of the study is to test the effects of a herbal supplement, Phytalgic, on the symptoms of osteoarthritis of the knee or hip, in patients with OA using NSAIDs or analgesics on a regular basis.

Condition Intervention
Osteoarthritis Dietary Supplement: phytalgic Dietary Supplement: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Double-Blind Study of Food Supplement Phytalgic on Symptoms of Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Université Victor Segalen Bordeaux 2:

Primary Outcome Measures:
  • use of NSAIDs or analgesics [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • WOMAC function scale [ Time Frame: 3 months ]

Enrollment: 81
Study Start Date: January 2007
Study Completion Date: April 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Dietary Supplement: phytalgic
3/day
Placebo Comparator: 2 Dietary Supplement: placebo
3/Day

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • knee or hip osteoarthritis
  • regular NSAIDs/analgesic treatment
  • signed inform consent

Exclusion Criteria:

  • incapacity to understand study
  • irregular NSAID treatment
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00666523


Locations
France
Dept of Pharmacology, U-Bordeaux2, BP36
Bordeaux, France, 33076
Sponsors and Collaborators
Université Victor Segalen Bordeaux 2
laboratoire Phythea, France
Investigators
Study Director: Nicholas Moore, MD, PhD University of Bordeaux
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alain Jacquet, Dept of pharmacology, CHU Bordeaux
ClinicalTrials.gov Identifier: NCT00666523     History of Changes
Other Study ID Numbers: PhytalgicOA
First Submitted: April 23, 2008
First Posted: April 25, 2008
Last Update Posted: April 25, 2008
Last Verified: April 2008

Keywords provided by Université Victor Segalen Bordeaux 2:
osteoarthritis, knee or hip

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases