Study period | |||
Enrolment | Postallocation | Close-out | |
Timepoints | Month 0 | Month 3 | Month 6 |
Eligibility screen | X | – | – |
Informed consent | X | – | – |
Allocation | X | – | – |
Delivery of the experimental product | X | – | – |
Delivery of a participating card | X | – | – |
Instructions to keep and return the pillboxes | X | – | – |
Interventions | |||
Oral resveratrol | |||
Oral placebo | |||
Assessments | |||
Baseline variables | |||
Demographics | X | – | – |
Medical history | X | – | – |
Outcome measures (analyses planned) | |||
Knee pain | X | X | X |
WOMAC function subscore | X | X | X |
Patient global assessment | X | X | X |
OARSI–OMERACT response | – | X | X |
Analgesics and NSAIDs consumption | X | X | X |
Injections of hyaluronic acid and/or corticosteroids | X | X | X |
Collected variables (no analyses planned) | |||
Symptomatic slow acting drugs for OA consumption | |||
Non-pharmacological co-interventions | X | X | X |
Adverse events | – | X | X |
Adherence | – | X | X |
NSAIDs, non-steroidal anti-inflammatory drugs; OA, osteoarthritis; OARSI, Osteoarthritis Research Society International; OMERACT, Outcome Measures in Rheumatology; WOMAC, Western Ontario and McMaster Universities Arthritis Index.