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Effect of Phytalgic in Osteoarthritis (OA)

This study has been completed.
Sponsor:
Collaborator:
laboratoire Phythea, France
Information provided by:
Université Victor Segalen Bordeaux 2
ClinicalTrials.gov Identifier:
NCT00666523
First received: April 23, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • use of NSAIDs or analgesics [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • WOMAC function scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Alain Jacquet, Dept of pharmacology, CHU Bordeaux
ClinicalTrials.gov Identifier: NCT00666523     History of Changes
Other Study ID Numbers: PhytalgicOA
Study First Received: April 23, 2008
Last Updated: April 23, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on May 22, 2013