Knee osteoarthritis Musculoskeletal Diseases Gonarthrosis [arthrosis of knee]
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Mild to moderate OA at both screening and baseline visits, as defined by the up-to-date revised American College of Rheumatology (ACR) criteria for diagnosis of knee OA
Exclusion criteria
Exclusion criteria: 1. Patients with a history of rheumatoid arthritis, gout, severe ischaemic heart disease, heart failure, hepatic failure, renal failure 2. Consumption of non-steroidal anti-inflammatory drugs or corticosteroid drugs within 4 weeks of study, intra-articular injection within 3 months prior to the study recruitment 3. Pregnant or desire to become pregnant, or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Specific biomarkers of osteoarthritis (Coll 2-1 and Aggrecan) measured using enzyme-linked immunosorbent assay (ELISA) kit according to the manufacturer instructions before treatment (at day 0) and after 90 days of treatment. 2. Biomarkers of inflammation including TNF-a, IL-1ß, IL-6 (measured using ELISA kit according to the manufacturer instructions) and hsCRP and the complement system (measured by spectrophotometry utilizing ready-made kits and Roche/Hitachi cobas c systems) measured at baseline at Day 0 (pre-treatment) and at day 90 (post treatment) 3. Standard haematological profile (measured utilizing the Swelab Alfa Plus system) and both liver and kidney functions markers (liver and kidney function tests), and lipid profiles measured spectrophotometrically using the clinical chemistry analyzer Cobas c 311 and ready-made kits according to the manufacturer’s recommendations for evaluating safety and tolerability of resveratrol at baseline and at the end of the treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptoms of osteoarthritis measured using the adopted scoring systems of visual analogue scale for pain (VAS) and Knee injury and Osteoarthritis Outcome Score (KOOS) at baseline (day 0), 1, 2 and 3 months | — |
Countries
Iraq