Effect of Phytalgic in Osteoarthritis (OA)

This study has been completed.

First Received: April 23, 2008 No Changes Posted

Sponsors and Collaborators:	Université Victor Segalen Bordeaux 2 laboratoire Phythea, France
Information provided by:	Université Victor Segalen Bordeaux 2
ClinicalTrials.gov Identifier:	NCT00666523

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

MedlinePlus related topics: Dietary Supplements Diets Osteoarthritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Randomized Double-Blind Study of Food Supplement Phytalgic on Symptoms of Osteoarthritis

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
1: Experimental	Dietary Supplement: phytalgic 3/day
2: Placebo Comparator	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:	Dept of pharmacology, CHU Bordeaux ( Alain Jacquet )
Study ID Numbers:	PhytalgicOA
Study First Received:	April 23, 2008
Last Updated:	April 23, 2008
ClinicalTrials.gov Identifier:	NCT00666523 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Université Victor Segalen Bordeaux 2:

osteoarthritis, knee or hip

Study placed in the following topic categories:

Osteoarthritis, Knee
Musculoskeletal Diseases
Osteoarthritis

Joint Diseases
Arthritis
Rheumatic Diseases

Additional relevant MeSH terms:

Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 07, 2009