Effect of Phytalgic in Osteoarthritis (OA)

April 23, 2008 updated by: Université Victor Segalen Bordeaux 2

Randomized Double-Blind Study of Food Supplement Phytalgic on Symptoms of Osteoarthritis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33076
        • Dept of Pharmacology, U-Bordeaux2, BP36

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • incapacity to understand study
  • irregular NSAID treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 2
Dietary supplement: placebo
3/Day
EXPERIMENTAL: 1
Dietary supplement: phytalgic
3/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
use of NSAIDs or analgesics
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
WOMAC function scale
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université Victor Segalen Bordeaux 2

Collaborators

laboratoire Phythea, France

Investigators

  • Study Director: Nicholas Moore, MD, PhD, University of Bordeaux

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (ACTUAL)

January 1, 2008

Study Completion (ACTUAL)

April 1, 2008

Study Registration Dates

First Submitted

April 23, 2008

First Submitted That Met QC Criteria

April 23, 2008

First Posted (ESTIMATE)

April 25, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

April 25, 2008

Last Update Submitted That Met QC Criteria

April 23, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PhytalgicOA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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