A clinical study to assess the efficacy of a green-lipped mussel (GLM) extract in people with knee osteoarthritis.

Phase 2

Recruiting

• Conditions: Knee Osteoarthritis; Gastrointestinal Symptoms; Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12613000261718
• Lead Sponsor: Aroma New Zealand Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

Age 40 years and older with clinical evidence of painful knee (osteoarthritis) OA for at least 6 months (with a pain numerical scale of 4 and above at baseline) and radiographic evidence of knee OA as determined as having a kellgren-Lawrence grade 2- or 3-. Not taking any dietary supplements including fish oils, glucosamine, green-lipped mussel, herbal preparations, antibiotics and probiotics 4 weeks before commencing trial.

Exclusion Criteria

knee replacements(s) of affected knee with OA; intra-articular therapies (knee cortisone injection and arthroscopy) within 3 months of starting the trial; pregnancy; use of illicit drugs; alcohol abuse; shell fish allergy; uncontrolled chronic health conditions i.e. diabetes, hypertension, cardiovascular disease; the inability to with-hold from using non-steroidal antiinflammatory drugs (NSAIDs) for the duration of the trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Knee pain, stiffness and physical function as determined by the Western Ontario McMasters Universities Arthritis Index and Lequesne Algofunctional Index questionnaires<br>[baseline, 6 weeks and 12 weeks];Faecal Microbial Bacterial Analysis - to determine bacterial genera and species[baseline and 12 weeks]

Secondary Outcome Measures

Name	Time	Method
Gastrointestinal Symptom Rating Scale (GSRS) to determine gastrointestinal symptoms[baseline, 6 weeks and 12 weeks];Numeric Pain Intensity Scale - indicates knee pain between 0 (no pain) and 10 (almost extreme pain)[baseline, 6 weeks and 12 weeks];Intermittent and Constant Osteoarthritis Pain (ICOAP) - distinguishes between two distinct types of pain in osteoarthritis. An aching and fairly constant background pain and a less frequent but more intense and often unpredictable pain[baseline, 6 weeks and 12 weeks];SF-12 Health Questionnaire - to assess physical and mental health status[baseline, 6 weeks and 12 weeks];Consumption of paracetamol (as Panadol osteo)[6 weeks and 12 weeks];Blood safety markers - electrolytes, liver function test, full blood count and inflammatory markers C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR)[baseline and 12 weeks]