Resveratrol in Knee Osteoarthritis

Assistance Publique - Hôpitaux de Paris142 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

142

Conditions

Knee Osteoarthritis

Interventions

oral resveratrolDRUG

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.

oral placeboDRUG

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

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (3)

Rheumatology Department, Saint Antoine Hospital

Paris, Paris, France

Rehabilitation Department, Cochin Hospital

Paris, Paris, France

Rehabilitation department , CHU Clermont-Ferrand

Cébazat, France

Outcomes

Primary Outcomes

Mean change from baseline in knee pain in the previous 48 hours

Using a self-administered 11-point pain numeric rating scale, with 0 = no pain and 100 = maximal pain

Time frame: at 3 months

Secondary Outcomes

Mean change from baseline in knee pain in the previous 48 hours

Using a self-administered 11-point pain numeric rating scale, with 0 = no pain and 100 = maximal pain

Time frame: at 6 months

Mean change from baseline in specific activity limitation

Using self-administered WOMAC function subscore, with 0 = no

Time frame: at 3 months

Mean change from baseline in specific activity limitation

Using self-administered WOMAC function subscore, with 0 = no

Time frame: at 6 months

Mean change from baseline in patient's global assessment

Using a self-administered 11-point global assessment numeric rating scale, with 0 = worst possible and 100 = best possible

Time frame: at 3 months

Mean change from baseline in patient's global assessment

Using a self-administered 11-point global assessment numeric rating scale, with 0 = worst possible and 100 = best possible

Time frame: at 6 months

Proportion of OARSI-OMERACT responders

OARSI-OMERACT response

Time frame: at 3 months

Proportion of OARSI-OMERACT responders

Data from ClinicalTrials.gov

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