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

Osteoarthritis, Knee Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00992004
• Other study ID #: ARKOS
• Secondary ID: 2009-A00174-53
• Status: Completed
• Phase: Phase 2
• First received: October 7, 2009
• Last updated: May 6, 2010
• Start date: June 2009
• Est. completion date: May 2010

Study information

• Verified date: May 2010
• Source: Bioxtract SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Dietary Supplement:
• Arantal® (highly bioavailable turmeric extract)
4 capsules a day, before breakfast

Locations

Country	Name	City	State
France	Henri Mondor Hospital	Creteil

Sponsors (2)

Lead Sponsor	Collaborator
Bioxtract SA	NuKleus

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS)		15 days	No
Secondary	Kinetics of the analgesic effect by a variance analysis in repeated measures (Likert Scale)		15 days	No