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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-A01310-51 | Registry Identifier | ANSM |
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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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The purpose of this study is to determine whether resveratrol is effective in the treatment of painful knee osteoarthritis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christelle NGUYEN, MD, PhD | Université Paris Descartes, PRES Sorbonne Paris Cité | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rheumatology Department, Saint Antoine Hospital | Paris | Paris | 75012 | France | ||
| Rehabilitation Department, Cochin Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39137167 | Result | 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. | |
| 28965100 | Result |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000077185 | Resveratrol |
| ID | Term |
|---|---|
| D000081225 | Stilbestrols |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
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| 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 |
|
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 |
| Paris |
| Paris |
| 75014 |
| France |
| Rehabilitation department , CHU Clermont-Ferrand | Cébazat | 63118 | France |
| 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. |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D059808 | Polyphenols |
| D010636 | Phenols |