Resveratrol in Knee Osteoarthritis (ARTHROL)

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 3

Conditions: Knee Osteoarthritis

Treatments: Drug: oral resveratrol; Drug: oral placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02905799

P150938

2016-A01310-51 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to determine whether resveratrol is effective in the treatment of painful knee osteoarthritis.

Full description

Osteoarthritis (OA) is the first cause of handicap in individuals over 40 years-old in France. OA physiopathology is driven in part by local joint inflammation responsible for pain and joint destruction. Experimental studies have shown that resveratrol, a molecule antagonist to the aryl hydrocarbon receptor, has anti-inflammatory and chondroprotective properties in vitro and in vivo. The investigators hypothesize that oral resveratrol, in a new formulation improving its bioavailability, could reduce knee pain at 3 months as compared with placebo in people with knee OA.

Enrollment: 142 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 40 years-old
• Knee osteoarthritis fulfilling 1986 American College of Rheumatology (ACR) criteria
• Pain on numeric rating scale ≥ 40/100
• Symptom duration ≥ 1 month
• Kellgren and Lawrence X-Ray score 1, 2 or 3
• Written consent obtained
• Health insurance cover

Exclusion criteria

• History of symptomatic crystal or inflammatory arthritis
• Knee surgery ≤ 1 year
• Knee trauma ≤ 2 months
• Knee intra-articular injections of corticosteroids and/or hyaluronic acid ≤ 2 months
• Neurologic disorders involving the lower limbs
• Patient not understanding and not speaking french
• Participation in another biomedical research
• Contraindication to resveratrol or hypersensitivity to any of its constituents
• Current use of intramuscular, intravenous or oral corticosteroids
• Uncontrolled diseases that may require intramuscular, intravenous or oral corticosteroids
• Current use of anticoagulants

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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142 participants in 2 patient groups, including a placebo group

Oral resveratrol

Experimental group

Description:

Resveratrol will be administered orally, at the dose of 40 mg (2 caplets) twice a day for one week, then at the dose of 20 mg (1 caplet) twice a day, for a total duration of 6 months.

Treatment:

Drug: oral resveratrol

Oral Placebo

Placebo Comparator group

Description:

Placebo will be administered orally : 2 caplets twice a day for one week, then 1 caplet twice a day, for a total duration of 6 months.

Treatment:

Drug: oral placebo