Evaluation of the Efficacy of a Turmeric Extract (Arantal®) in Patients With Osteoarthritis of the Knee (Gonarthrosis).

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).

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Dietary supplement: Arantal® (highly bioavailable turmeric extract)

• Study Type: Interventional
• Enrollment (Anticipated): 280
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Creteil, France, 94000
    • Henri Mondor Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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,
  • Hyaluronan injection in the evaluated knee during the previous 6 months,
  • Patient who took NSAID in the 72 hours prior to inclusion or Analgesics in the 24 hours prior to inclusion,
  • Slow-acting drugs for OA and/or dietary supplements taken within less than 3 months prior to the study product administration or for which the dose has been modified in the last three months (ex: chondroitin sulfate, diacerein, soy and avocado unsaponifiables, oxaceprol, granions de cuivre, glucosamine, phytotherapy for OA, homeopathy for OA...),
  • Anticoagulant treatment without gastric protection,
  • General corticotherapy,
  • Contraindication to paracetamol.

• Related to associated pathologies:

  • Patient suffering from serious associated illness (liver failure, kidney failure, non-controlled cardiovascular diseases...),
  • Peptic ulcer.

• Related to patients:

  • Pregnant or breastfeeding women
  • Pre-menopausal women with no contraception
  • Patients unable to write
  • Patients enrolled in a clinical trial in the previous 3 months
  • Patients under juristic protection or under guardianship.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arantal®; Highly bioavailable turmeric extract (food supplement)	Dietary supplement: Arantal® (highly bioavailable turmeric extract); 4 capsules a day, before breakfast
Placebo Comparator: Placebo; Same capsule without the active ingredients (only excipients)	Dietary supplement: Arantal® (highly bioavailable turmeric extract); 4 capsules a day, before breakfast

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS)	15 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Kinetics of the analgesic effect by a variance analysis in repeated measures (Likert Scale)	15 days

Collaborators and Investigators

• Sponsor: Bioxtract SA
• Collaborators: Nukleus
• Investigators: Principal Investigator: Yves Henrotin, Pr, University of Liege - Bone and Cartilage Research Unit

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: October 7, 2009
• First Submitted That Met QC Criteria: October 7, 2009
• First Posted (Estimate): October 8, 2009

Study Record Updates

• Last Update Posted (Estimate): May 7, 2010
• Last Update Submitted That Met QC Criteria: May 6, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: Arthritis; Osteoarthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis, Knee
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants; Turmeric extract
• Other Study ID Numbers: ARKOS; 2009-A00174-53