Resveratrol in Knee Osteoarthritis (ARTHROL)

A

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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