Evaluation of the Efficacy of a Turmeric Extract (Arantal®) in Patients With Osteoarthritis of the Knee (Gonarthrosis).
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ClinicalTrials.gov Identifier: NCT00992004 |
Recruitment Status
:
Completed
First Posted
: October 8, 2009
Last Update Posted
: May 7, 2010
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Osteoarthritis, Knee | Dietary Supplement: Arantal® (highly bioavailable turmeric extract) | Phase 2 |
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 |

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
|
- Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS) [ Time Frame: 15 days ]
- Kinetics of the analgesic effect by a variance analysis in repeated measures (Likert Scale) [ Time Frame: 15 days ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00992004
France | |
Henri Mondor Hospital | |
Creteil, France, 94000 |
Principal Investigator: | Yves Henrotin, Pr | University of Liege - Bone and Cartilage Research Unit |
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 Key Record Dates |
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 |