Resveratrol in Knee Osteoarthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-09

Study Completion Date

2022-05-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy and Safety of Tongren-Dahuoluo Bolus in Patients with Knee Osteoarthritis

NCT06674759

Knee Osteoarthritis (Knee OA)

NOT_YET_RECRUITING PHASE4

Study of Efficacy, Safety and Tolerability of DFV890 in Patients With Knee Osteoarthritis

NCT04886258

Symptomatic Knee Osteoarthritis

COMPLETED PHASE2

A Study to Evaluate the Safety and Efficacy of 2ccPA in Patients With Symptomatic Knee Osteoarthritis

NCT05807529

Osteoarthritis, Knee

ACTIVE_NOT_RECRUITING PHASE1/PHASE2

A Dose-Finding Study to Evaluate the Efficacy and Safety of GSK3858279 in Adults With Knee Osteoarthritis (OA) Pain

NCT05838742

Pain Osteoarthritis, Knee

TERMINATED PHASE2

An Effectiveness and Safety Study of Acetaminophen Extended Release Caplets in the Treatment of Osteoarthritis of the Hip or Knee.

NCT00240799

Osteoarthritis

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Knee Osteoarthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Oral resveratrol

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.

Group Type EXPERIMENTAL

oral resveratrol

Intervention Type 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

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.

Group Type PLACEBO_COMPARATOR

oral placebo

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

oral resveratrol

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.

Intervention Type DRUG

oral placebo

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No