Evaluation of the Efficacy of a Turmeric Extract (Arantal®) in Patients With Osteoarthritis of the Knee (Gonarthrosis).
This study has been completed.
Sponsor:
Bioxtract SA
Collaborator:
NuKleus
Information provided by:
Bioxtract SA
ClinicalTrials.gov Identifier:
NCT00992004
First received: October 7, 2009
Last updated: May 6, 2010
Last verified: May 2010
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Osteoarthritis, Knee |
Dietary Supplement: Arantal® (highly bioavailable turmeric extract) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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). |
Resource links provided by NLM:
Further study details as provided by Bioxtract SA:
Primary Outcome Measures:
- Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS) [ Time Frame: 15 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Kinetics of the analgesic effect by a variance analysis in repeated measures (Likert Scale) [ Time Frame: 15 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 280 |
| Study Start Date: | June 2009 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| 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
More Information
No publications provided
| Responsible Party: | Dr Ingrid Jacquemond-Collet, bioXtract SA |
| ClinicalTrials.gov Identifier: | NCT00992004 History of Changes |
| Other Study ID Numbers: | ARKOS, 2009-A00174-53 |
| Study First Received: | October 7, 2009 |
| Last Updated: | May 6, 2010 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Belgium: Federal Agency for Medicinal Products and Health Products |
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 Pharmacologic Actions Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 21, 2013