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

Bioxtract SA

Status and phase: Completed; Phase 2

Conditions: Osteoarthritis, Knee

Treatments: Dietary Supplement: Arantal® (highly bioavailable turmeric extract)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00992004

2009-A00174-53

ARKOS

Details and patient eligibility

About

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.

Enrollment: 280 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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280 participants in 2 patient groups, including a placebo group

Arantal®

Experimental group

Description:

Highly bioavailable turmeric extract (food supplement)

Treatment:

Dietary Supplement: Arantal® (highly bioavailable turmeric extract)

Placebo

Placebo Comparator group

Description:

Same capsule without the active ingredients (only excipients)

Treatment:

Dietary Supplement: Arantal® (highly bioavailable turmeric extract)