A randomized controlled trial to study the effect of a dietary supplement - a novel marine extract (BioLex (Registered Trademark)) - for the treatment of osteoarthritis.

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2011
INTERVENTION: New Zealand Green Lipped Muscle (NZGLM) lipid extract blend (BioLex (Registered Trademark)) 2 x 150 mg oral capsules, 2 x daily, for 12 weeks CONDITION: Osteoarthritis of the knee and/or hip PRIMARY OUTCOME: Pain using the Visual Analogue Scale (VAS) Physical function using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) SECONDARY OUTCOME: A concomitant medication pill‐count of regular pain and anti‐inflammatory medication will occur at baseline, weeks 6, 12, and 15. Partcipants will attend an appointment with the research nurse on each occassion and supply all prescribed medication for scrutiny. This will be compared against medication diaries that will be filled out daily by each partcipant. Four (4) Functional (physical) measures: ; i) The stair climb test ; ii) The 30 second sit‐to‐stand test ; iii) Walking performance (Walking performance (speed) will be assessed using a stopwatch by calculating walking velocity (m/sec) as participants walk 20 meters) ; iv) Tandem Gait test for dynamic balance The Osteoarthritis Quality of Life questionnaire (OAQoL) INCLUSION CRITERIA: Patients suspected of having Osteoarthritis: (i) Knee or hip osteoarthritis fulfilling the American College of Rheumatology classification criteria with pain on most days of the past month and radiological changes (osteophytes and joint space narrowing) indicative of OA. (ii) Overall average hip/groin or knee pain in the last week >30 on 100 mm visual analogue scale (VAS) (to ensure a minimal level of pain); (iii) Pain in the groin, hip or knee region for more than 3 months; (iv) Disability related to their arthritis defined as a score of at least 0.5 on the Health Assessment Questionnaire (HAQ) (v) Aged >18 years.
Epistemonikos ID: 586a365cfb185adb8d7d73c2a11dc7f52e6f76a8
First added on: Aug 22, 2024