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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Osteoarthritis, Knee	Dietary Supplement: Arantal® (highly bioavailable turmeric extract)	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	280 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	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).
Study Start Date :	June 2009
Actual Primary Completion Date :	May 2010
Actual Study Completion Date :	May 2010

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS) [ Time Frame: 15 days ]

Secondary Outcome Measures :

1. Kinetics of the analgesic effect by a variance analysis in repeated measures (Likert Scale) [ Time Frame: 15 days ]

Eligibility Criteria

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Ages Eligible for Study:	40 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

France
Henri Mondor Hospital
Creteil, France, 94000

Sponsors and Collaborators

Bioxtract SA

Nukleus

Investigators

Principal Investigator:	Yves Henrotin, Pr	University of Liege - Bone and Cartilage Research Unit

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Dr Ingrid Jacquemond-Collet, bioXtract SA
ClinicalTrials.gov Identifier:	NCT00992004 History of Changes
Other Study ID Numbers:	ARKOS; 2009-A00174-53
First Posted:	October 8, 2009
Last Update Posted:	May 7, 2010
Last Verified:	May 2010

Keywords provided by Bioxtract SA:

Osteoarthritis, Knee; Osteoarthritis; Joint Diseases; Arthritis; Rheumatic Diseases

Additional relevant MeSH terms:

Osteoarthritis; Osteoarthritis, Knee; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases	Turmeric extract; Antioxidants; Molecular Mechanisms of Pharmacological Action; Protective Agents; Physiological Effects of Drugs