Resveratrol in Knee Osteoarthritis

NCT02905799 | Completed Phase 3

• 2 other identifiers: P1509382016-A01310-51
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Knee Osteoarthritis

Keywords

Osteoarthritis; Knee; Resveratrol; Oral Treatment; Pain; Trial

Outcome Measures

Primary Outcomes (1)

• 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

  at 3 months

Secondary Outcomes (13)

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

  at 6 months

• Mean change from baseline in specific activity limitation

  at 3 months

• Mean change from baseline in specific activity limitation

  at 6 months

• Mean change from baseline in patient's global assessment

  at 3 months

• Mean change from baseline in patient's global assessment

  at 6 months

Study Arms (2)

Oral resveratrol

EXPERIMENTAL

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.

Drug: oral resveratrol

Oral Placebo

PLACEBO COMPARATOR

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.

Drug: oral placebo

Interventions

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 resveratrol

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

Oral Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (3)

Rheumatology Department, Saint Antoine Hospital

Paris, Paris, 75012, France

Location

Rehabilitation Department, Cochin Hospital

Paris, Paris, 75014, France

Location

Rehabilitation department , CHU Clermont-Ferrand

Cébazat, 63118, France

Location

Related Publications (2)

• Nguyen C, Coudeyre E, Boutron I, Baron G, Daste C, Lefevre-Colau MM, Sellam J, Zauderer J, Berenbaum F, Rannou F. Oral resveratrol in adults with knee osteoarthritis: A randomized placebo-controlled trial (ARTHROL). PLoS Med. 2024 Aug 13;21(8):e1004440. doi: 10.1371/journal.pmed.1004440. eCollection 2024 Aug.

  PMID: 39137167 RESULT

• Nguyen C, Boutron I, Baron G, Coudeyre E, Berenbaum F, Poiraudeau S, Rannou F. Evolution of pain at 3 months by oral resveratrol in knee osteoarthritis (ARTHROL): protocol for a multicentre randomised double-blind placebo-controlled trial. BMJ Open. 2017 Sep 29;7(9):e017652. doi: 10.1136/bmjopen-2017-017652.

  PMID: 28965100 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Pain

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols

Study Officials

• Christelle NGUYEN, MD, PhD

  Université Paris Descartes, PRES Sorbonne Paris Cité

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2016
• First Posted: September 19, 2016
• Study Start: November 9, 2017
• Primary Completion: February 9, 2022
• Study Completion: May 12, 2022
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)