Comparative, Randomized, Double-blind, Placebo-controlled, Parallel Group Study, to Evaluate the Efficacy of a Turmeric Extract (Arantal®) Versus Placebo in Patients With Osteoarthritis of the Knee (Gonarthrosis).

Bioxtract SA1 site in 1 country280 target enrollmentJune 2009

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Osteoarthritis, Knee
Sponsor: Bioxtract SA
Enrollment: 280
Locations: 1
Primary Endpoint: Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS)
Status: Completed
Last Updated: 15 years ago

The purpose of this study is to determine the efficacy and the tolerance on 15 days of a turmeric extract (Arantal®) on pain related to gonarthrosis.

Registry

clinicaltrials.gov

Start Date

June 2009

End Date

May 2010

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Bioxtract SA

•Patient is 40 through 80 years of age
•Subject diagnosed with femorotibial osteoarthritis of the knee (diagnosed according to the clinical and radiologic criteria of ACR),
•Patient's Assessment of Arthritis Pain measurement on the last 24 hours of at least 50 mm on VAS,
•Patient has not received any NSAIDs within 72 hours and any analgesics within 24 hours,
•Patients with chronic knee pain (i.e., knee pain at least every other day during the month preceding inclusion),
•Patients with radiologic knee osteoarthritis (Kellgren-Lawrence grade 2-4, on radiography less than 12 months old),
•Patients having signed the informed consent,
•Patients capable of comprehend the study instructions.

•Related to the osteoarthritis pathology:
•Osteoarthritis linked to a metabolic arthropathy: chondrocalcinosis already diagnosed or defined by calcium edging on at least one femorotibial joint space, gout...,
•Predominant associated symptomatic femoropatellar osteoarthritis,
•Chondromatosis or villonodular synovitis of the knee,
•Recent trauma (\< 1 month) of the knee responsible for the pain,
•Knee joint effusion justifying an evacuation through puncturing,
•Inflammatory flare (night pain, joint effusion) corresponding to a KOFUS score less than 7,
•Pathology potentially interfering with the evaluation (metabolic inflammatory arthropathy, rheumatoid arthritis, lower limb radiculalgia, arthritis...),
•Related to previous and associated treatments:
•Corticosteroids injection in the previous month, whatever the joint concerned,