A randomised trial of Curcuma longa for treating symptoms and effusion-synovitis of knee osteoarthritis.

INTERVENTION: 35 patients with clinical knee osteoarthritis, significant knee pain and effusion‐synovitis on imaging will receive 1g (2 capsules of 500mg each) of Curcuma longa extract per day for 12 weeks. Adherence to treatment will be monitored by counting the returned capsules at the 12 week visit. CONDITION: Osteoarthritis PRIMARY OUTCOME: Change in effusion‐synovitis size from baseline to 12 weeks measured using MRI quantitative measurements in patients with symptomatic OA of the knee and knee effusion‐synovitis. Change in knee pain (assessed by 100mm VAS) over 12 weeks in patients with clinical knee OA ; ; The difference in adverse events reported (using adverse event form filled by a research nurse and reviewed by a physician) at week 4, 8 and 12 in patients with clinical knee OA, significant pain and effusion‐synovitis. OMERACT_OARSI responders (20% improvement in WOMAC pain) at week 4, 8 and 12 in patients with clinical knee OA, significant pain and effusion‐synovitis. INCLUSION CRITERIA: 1. Aged over 40 years old. 2. Men and women with significant knee pain on most days (defined as a VAS >40mm). 3. Knee effusion–synovitis on US (>=4mm thickness measure). 4. Meet American College of Rheumatology (ACR) clinical criteria for knee OA confirmed by a clinician. SECONDARY OUTCOME: Change in cartilage breakdown biomarkers (urinary CTX‐II, serum COMP and serum hyaluronan) from baseline to week 12 in patients with clinical knee OA, significant pain and effusion‐synovitis. These biomarkers will be assessed from urine and serum samples collected at baseline and 12 weeks. Change in concomitant medications (assessed using self‐reported medication history questionnaire) from screening to weeks 4, 8 and 12 in patients with clinical knee OA, significant pain and effusion‐synovitis. Change in physical function as assesed by 30s Chair Stand Test, 40m Fast Walk Test and Stair Climb Test in patients from baseline to week 12 with clinical knee OA, significant pain and effusion‐synovitis. Change in quality of life (assessed by AQoL‐15) from baseline to week 12 in patients with clinical knee OA, significant pain and effusion‐synovitis. Change in synovitis volume (synovitis measured using contrast‐enhanced MRI) from baseline to week 12 in patients with clinical knee OA, significant pain and effusion‐synovitis. Change in systemic inflammatory markers (hs‐CRP, IL‐6, TNF‐a) from baseline to week 12 in patients with clinical knee OA, significant pain and effusion‐synovitis. These biomarkers will be assessed from serum samples collected at baseline and 12 weeks. Change in T1p and T2 mapping values (cartilage composition measured using MRI) from baseline to week 12 in patients with clinical knee OA, significant pain and effusion‐synovitis. Change in the dGEMRIC index (delayed Gadolinium Enhanced MRI of the cartilage) from baseline to week 12 in patients with clinical knee OA, significant pain and effusion‐synovitis. Change in WOMAC knee function (assessed by WOMAC scoring system) from baseline to 4, 8 and 12 weeks in patients with clinical knee OA, significant pain and effusion‐synovitis. Change in WOMAC knee pain (total, weight bearing and non‐weight bearing) from baseline to 4, 8 and 12 weeks in patients with clinical knee OA , significant knee pain and effusion‐synovitis. Curcuma Longa is a very safe medication, with no major side effects attributable to the drug. Curcuma Longa treatments in clinical trials have reported gastrointestinal symptoms including dyspepsia and regurgitation. However, the control groups such as placebo and pain medicine (ibuprofen and diclofenac) also showed similar adverse effects.