Effect of Phytalgic in Osteoarthritis (OA)

NCT ID: NCT00666523

Last Updated: 2008-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis

Keywords

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osteoarthritis, knee or hip

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

phytalgic

Intervention Type DIETARY_SUPPLEMENT

3/day

2

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

3/Day

Interventions

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phytalgic

3/day

Intervention Type DIETARY_SUPPLEMENT

placebo

3/Day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* incapacity to understand study
* irregular NSAID treatment
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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laboratoire Phythea, France

UNKNOWN

Sponsor Role collaborator

Université Victor Segalen Bordeaux 2

OTHER

Sponsor Role lead

Responsible Party

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Dept of pharmacology, CHU Bordeaux

Principal Investigators

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Nicholas Moore, MD, PhD

Role: STUDY_DIRECTOR

University of Bordeaux

Locations

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Dept of Pharmacology, U-Bordeaux2, BP36

Bordeaux, , France

Site Status

Countries

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France

References

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Jacquet A, Girodet PO, Pariente A, Forest K, Mallet L, Moore N. Phytalgic, a food supplement, vs placebo in patients with osteoarthritis of the knee or hip: a randomised double-blind placebo-controlled clinical trial. Arthritis Res Ther. 2009;11(6):R192. doi: 10.1186/ar2891. Epub 2009 Dec 16.

Reference Type DERIVED
PMID: 20015358 (View on PubMed)

Other Identifiers

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PhytalgicOA

Identifier Type: -

Identifier Source: org_study_id