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Completed

NCT Number: NCT02905799

Resveratrol in Knee Osteoarthritis

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

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Osteoarthritis, Knee Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Rehabilitation Department, Cochin Hospital, Paris, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oral resveratrol

Drug

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 placebo

Drug

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

Primary outcomes

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

    Time frame: at 3 months

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

Secondary outcomes

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

    Time frame: at 6 months

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

  2. Mean change from baseline in specific activity limitation

    Time frame: at 3 months

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

  3. Mean change from baseline in specific activity limitation

    Time frame: at 6 months

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

  4. Mean change from baseline in patient's global assessment

    Time frame: at 3 months

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

  5. Mean change from baseline in patient's global assessment

    Time frame: at 6 months

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

  6. Proportion of OARSI-OMERACT responders

    Time frame: at 3 months

    OARSI-OMERACT response

  7. Proportion of OARSI-OMERACT responders

    Time frame: at 6 months

    OARSI-OMERACT response

  8. Number of intra-articular injections of corticosteroids or hyaluronic acid since last contact

    Time frame: at 3 months

    using self-reporting

  9. Number of intra-articular injections of corticosteroids or hyaluronic acid since last contact

    Time frame: at 6 months

    using self-reporting

  10. Self-reported consumption of analgesics (non-opioid, weak and strong opioids) since last contact

    Time frame: at 3 months

    using a self-administered 4-class scale (never, several times a month, several times a week, daily)

  11. Self-reported consumption of analgesics (non-opioid, weak and strong opioids) since last contact

    Time frame: at 6 months

    using a self-administered 4-class scale (never, several times a month, several times a week, daily)

  12. Self-reported consumption of non-steroidal anti-inflammatory drugs since last contact

    Time frame: at 3 months

    using a self-administered 4-class scale (never, several times a month, several times a week, daily)

  13. Self-reported consumption of non-steroidal anti-inflammatory drugs since last contact

    Time frame: at 6 months

    using a self-administered 4-class scale (never, several times a month, several times a week, daily)

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

Evolution of Pain at Three Months by Oral Resveratrol in Primary Knee Osteoarthritis: a Multicenter, Double-blind, Randomized, Placebo-controlled Trial

Acronym: ARTHROL

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Sep 19, 2016
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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