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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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 19, 2014