None listed
Conditions
Brief summary
Osteoarthritis (OA) is a chronic, degenerative joint condition, resulting from wear of the articular cartilage. Symptomatic treatment typically involves the use of high dose paracetamol, non-steroidal anti-inflammatory drugs, and/or opiate analgesics; however, these may produce adverse effects. A variety of products derived from the New Zealand Green Lipped Mussel (NZGLM; Perna canaliculus) have been advocated as a treatment for OA on the basis of their reputed anti-inflammatory activity. BioLex (Registered Trademark) contains a novel NZGLM lipid extract and a vegetable oil carrier. The aim of the proposed study is to compare the effects of BioLex (Registered Trademark) with placebo on the signs, symptoms, and quality of life in patients with moderate to severe OA of the hip and/or knee, along with their use of pain relief medication. Specifically the study hypotheses are: H1: A 12-week course of BioLex (Registered Trademark) will result in significantly greater improvements in pain, physical function, quality of life measures, and physical measures of function than placebo in individuals with OA of the hip and/or knee. H2: A 12-week course of BioLex (Registered Trademark) will result in reductions in pain and anti-inflammatory medication use compared to placebo in individuals with OA of the hip and/or knee. H3: BioLex (Registered Trademark) will be associated with fewer adverse effects than standard analgesic regimens.
Interventions
New Zealand Green Lipped Muscle (NZGLM) lipid extract blend (BioLex (Registered Trademark))
2 x 150 mg oral capsules, 2 x daily, for 12 weeks
Sponsors
Dr Tony Schneiders
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Exclusion criteria
(i) Hip or knee surgery within past 6 months; (ii) Awaiting or planning any back or lower limb surgery in the next 3 months; (iii) Current or recent (in the last 3 months) oral or intraarticular corticosteroid therapy; (iv) Inflammatory arthritis such as rheumatoid arthritis; (v) History of hip or knee joint replacement or osteotomy at index joint; (vi) Other previous hip or knee pathology such as a recent fracture (<3 months) or malignancy at the index joint; (vii) Other co-existent muscular, joint or neurological condition causing pain or affecting lower limb function (e.g. trauma, shingles); (viii) Any medical or physical impairment apart from hip or knee OA precluding safe participation in exercise/function based assessments such as uncontrolled hypertension, fibromyalgia, chronic fatigue syndrome or morbid obesity (body mass index > 40); (ix) Seafood or corn hypersensitivity or allergy; (x) Inability to comply with study protocol; (xi) Inadequate written and spoken English; (xii) Psychiatric illness – major depressive illness or psychosis; (xiii) Pregnancy; (xiv) Inter-current acute infections.
Outcome results
None listed