None listed
Conditions
Brief summary
This is a pilot study designed to gather data pertinent to the development of a large scale clinical trial, The study is an open label trial to be conducted over 12 weeks in otherwise healthy individuals. The study will compare baseline Comprehensive Osteoarthritis Test (COAT) measurements with end of study outcomes
Interventions
Seaweed extract derived from Marine macroalgae, dose complarison study. Five participants will take 100grams twice a day and five will take 1gram twice a day. The tablets will be self-administered by the participants each morning before breakfast and each evening. The study will continue for 12 weeks after the initial baseline visit, measurement points are at baseline, week 1, week 6 and week 12.
Sponsors
Marinova Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
X-ray and clinical evidence of osteoarthritis of the kneesIn good general healthAdequate venous accessParticipants willing to discontinue their current OA (osteoarthritis) treatment for the duration of the study. This includes treatment with intra-articular injections, corticosteroids, NSAIDs (non steroidal anti inflammatory drug), non-prescription therapies, chondroprotective agents, occlusive dressings, physiotherapy, or orthopaedic technical measuresParticipants of childbearing age who agree to continue using birth control measures for the duration of the study.
Exclusion criteria
A history of trauma associated with the affected jointRheumatoid or other inflammatory joint conditionsGoutUse of corticosteroids (intra-articular or systematic) within 4 weeks prior to baseline and throughout the studyUse of anti-inflammatory agents or anti-arthritic complementary medicines 3 weeks prior to baseline and for the duration of the studyLiver function tests greater than 3 times the upper limit of normal at baselineHistory of alcohol or substance abuseFemale participants who are lactating, pregnant or planning to become pregnantParticipants who have participated in another clinical trial in the last 30 daysParticipants unwilling to comply with the study protocolAny other condition, which in the opinion of the investigators could compromise the study.
Outcome results
None listed