None listed
Conditions
Brief summary
The primary objective of this clinical research is to establish the effects of a standardised green-lipped mussel lipid extract (PCSO-524) in women and men with osteoarthritis (OA) of the knee. The study seeks to determine the effective dosage and will be conducted using an open-label design and is categorised as a Phase II clinical trial. Participants meeting the enrolment criteria will be randomised to either 200mg or 400mg daily for a 12 week period. The primary validated measurement will be the Comprehensive Osteoarthritis Test (COAT) which we developed in previous clinical trials on OA. The results will be used to inform a Phase III randomised controlled study.
Interventions
Study Medication: Oral capsules of standardised New Zealand Green-Lipped Mussel Lipid Extract (PCSO-524)
Dosage: Participants will be randomised to receive either 200mg (given as 2x50mg morning and night); OR 400mg daily (given as 2x100mg morning and night)
Duration: 12 weeks
Sponsors
NatMed Research
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
45 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Women: 45-75 years of age (yoa) with a history of knee OA; onset 45 yoa or older; perceived pain between 30 and 70 on a 100mm visual analogue scale (VAS); X-ray evidence of osteoarthritis (KL score = 2 or 3); Follicle Stimulating Hormone (FSH) > 18.0 U/L; BMI < 35; otherwise healthy. Men: 45-80 years of age (yoa) with a history of kneeOA; onset 43 yoa or older; perceived pain between 30 and 70 on a 100mm visual analogue scale (VAS); X-ray evidence of osteoarthritis (KL score = 2 or 3); BMI < 35; central obesity); otherwise healthy.
Exclusion criteria
Perceived pain <30 or >70 on a 100mm VAS; any significant active chronic disease; taking any anti-inflammatory or anti-arthritic medicines.
Outcome results
None listed