Resveratrol in Knee Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether resveratrol is effective in the treatment of painful knee osteoarthritis.

Detailed 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.

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

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Drug: oral resveratrol
* Drug: oral placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral resveratrol<br>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<br>* 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.<br>|
| Placebo Comparator: Oral Placebo<br>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<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 6 months | 
| Mean change from baseline in specific activity limitation | Using self-administered WOMAC function subscore, with 0 = no | at 3 months | 
| Mean change from baseline in specific activity limitation | Using self-administered WOMAC function subscore, with 0 = no | 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 | 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 | at 6 months | 
| Proportion of OARSI-OMERACT responders | OARSI-OMERACT response | at 3 months | 
| Proportion of OARSI-OMERACT responders | OARSI-OMERACT response | at 6 months | 
| Number of intra-articular injections of corticosteroids or hyaluronic acid since last contact | using self-reporting | at 3 months | 
| Number of intra-articular injections of corticosteroids or hyaluronic acid since last contact | using self-reporting | at 6 months | 
| Self-reported consumption of analgesics (non-opioid, weak and strong opioids) since last contact | using a self-administered 4-class scale (never, several times a month, several times a week, daily) | at 3 months | 
| Self-reported consumption of analgesics (non-opioid, weak and strong opioids) since last contact | using a self-administered 4-class scale (never, several times a month, several times a week, daily) | at 6 months | 
| Self-reported consumption of non-steroidal anti-inflammatory drugs since last contact | using a self-administered 4-class scale (never, several times a month, several times a week, daily) | at 3 months | 
| Self-reported consumption of non-steroidal anti-inflammatory drugs since last contact | using a self-administered 4-class scale (never, several times a month, several times a week, daily) | at 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis, Knee, Resveratrol, Oral Treatment, Pain, Trial