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RecruitingPhase 2ACTRN12616000975493

Efficacy and safety of a marine extract for the treatment of osteoarthritis.

An Open Label Phase II Study on a Marine Extract on Osteoarthritis.

Sponsor

NatMed Research

Enrollment

60 participants

Start Date

Jul 25, 2016

Study Type

Interventional

Conditions

Osteoarthritis of the knee

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.

Eligibility

Sex: Both males and femalesMin Age: 45 YearssMax Age: 80 Yearss

Plain Language Summary

Simplified for easier understanding

This study is for men and women with knee osteoarthritis — a condition where the cartilage in the knee wears down, causing pain and stiffness. It tests whether a supplement made from green-lipped mussel extract (PCSO-524) helps reduce knee pain. Participants will take either 200 mg or 400 mg of the supplement daily for 12 weeks. You may be eligible if: - Women: You are between 45 and 75 years old, with knee osteoarthritis starting at 45 or older, confirmed by X-ray - Men: You are between 45 and 80 years old, with knee osteoarthritis starting at 43 or older, confirmed by X-ray - Your knee pain score is between 30 and 70 on a 100-point scale - Your BMI is below 35 - You are otherwise in general good health You may NOT be eligible if: - Your pain score is below 30 or above 70 - You have any significant active chronic illness - You are currently taking anti-inflammatory or anti-arthritis medicines Talk to your doctor about whether this trial might be right for you.

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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

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

Locations(1)

NSW, Australia

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ACTRN12616000975493

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