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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Randomised Controlled Trial of a Marinova Seaweed Extract on Osteoarthritis
Scientific title
A Randomised Controlled Trial of Adults with Osteoarthritis treated with a Marinova Seaweed Extract compared to a Placebo measured by the Comprehensive Osteoarthritis Test (COAT).
Secondary ID [1] 262835 0
Universal Trial Number (UTN)
UTN: U1111-1123-7318
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 285633 0
Condition category
Condition code
Musculoskeletal 270724 270724 0 0

Study type
Description of intervention(s) / exposure
500mg capsule taken orally twice daily containing 150mg Fucus vesiculosis (seaweed) extract and 350mg Microcrystaline Cellulose (MCC)
for 12 weeks.
Intervention code [1] 269189 0
Treatment: Other
Comparator / control treatment
500mg capsule taken twice daily containing 500mg MCC for 12 weeks.
Control group

Primary outcome [1] 269430 0
Comprehensive Osteoarthritis Test (COAT) consisting of 4 items measured on 100mm visual analogue scale (VAS) response scales: joint pain, stiffness, difficulties with physical activities, overall symptoms.
Timepoint [1] 269430 0
Baseline, week4, week 8, week 12
Secondary outcome [1] 287623 0
high sensitivity C-reactive protein (CRP) by blood analysis.
Timepoint [1] 287623 0
Baseline and week 12
Secondary outcome [2] 287624 0
Interleukin 6 (IL-6) by blood analysis
Timepoint [2] 287624 0
Baseline and week 12
Secondary outcome [3] 287625 0
Tumour Necrosis Factor alpha (TNF-alpha) by blood analysis.
Timepoint [3] 287625 0
Baseline and week 12
Secondary outcome [4] 287626 0
Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC). The Index is self-administered and assesses the three dimensions of pain, disability and joint stiffness in knee and hip osteoarthritis using a battery of 24 questions.
Timepoint [4] 287626 0
Baseline, week 4, week 8, week 12
Secondary outcome [5] 294128 0
Radial arterial pressure wave using SphygmoCor technology equiptment for assessment.
Timepoint [5] 294128 0
Baseline and week 12

Key inclusion criteria
Females and males, aged between 18 and 85 years.
X-ray and clinical evidence of osteoarthritis of the knees.
In good general health.
Adequate venous access.
Female participants of childbearing age who agree to continue using birth control measures for the duration of the study.
Minimum age
18 Years
Maximum age
85 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
A history of trauma associated with the affected joint.
Rheumatoid or other inflammatory joint conditions.
Individuals with thyroid disorder.
Individuals with diabetes.
Individuals taking Warfarin of other anti-coagulant medication.
Participants with a VAS score above 7 at baseline.
Participants who have just commenced on a treatment regimen for arthritis.
Use of corticosteroids (intra-articular or systematic) within 4 weeks prior to baseline and throughout the study.
Liver function tests greater than 3 times the upper limit of normal at baseline.
History of alcohol or substance abuse.
History of allergy to iodine or shell fish.
Female participants who are lactating, pregnant or planning to become pregnant.
Participants who have participated in another clinical trial in the last 30 days.
Participants unwilling to comply with the study protocol.
Participants unable to complete COAT scale appropriately.
Any other condition, which in the opinion of the investigators could compromise the study.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participant allocation will be according to an independently generated schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated block design
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4354 0
Recruitment postcode(s) [2] 4355 0
Recruitment postcode(s) [3] 4356 0
Recruitment postcode(s) [4] 4357 0

Funding & Sponsors
Funding source category [1] 269659 0
Commercial sector/Industry
Name [1] 269659 0
Marinova Pty Ltd
Address [1] 269659 0
249 Kennedy Drive
Tasmania 7170
Country [1] 269659 0
Primary sponsor type
Commercial sector/Industry
Marinova Pty Ltd
249 Kennedy Drive
Tasmania 7170
Secondary sponsor category [1] 266697 0
Name [1] 266697 0
Address [1] 266697 0
Country [1] 266697 0

Ethics approval
Ethics application status
Ethics committee name [1] 269608 0
Southern Cross University Human Research Ethics Committee
Ethics committee address [1] 269608 0
Military Road
East Lismore NSW 2480
Ethics committee country [1] 269608 0
Date submitted for ethics approval [1] 269608 0
Approval date [1] 269608 0
Ethics approval number [1] 269608 0

Brief summary
The purpose of the study is to determine the efficacy and safety of a Marinova seaweed supplement in improving symptoms in participants with diagnosed osteoarthritis of the knee. The primary hypothesis is that the oral administration of the study medication over 12 weeks will result in a statistically significant decrease in osteoarthritis symptoms in comparison with a placebo.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 33020 0
Prof Stephen Myers
Address 33020 0
NatMed Research
Rifle Range Rd
East Lismore NSW 2480
Country 33020 0
Phone 33020 0
61-2-6620 3643
Fax 33020 0
Email 33020 0
Contact person for public queries
Name 16267 0
Prof Stephen Myers
Address 16267 0
NatMed Research
Rifle Range Rd
East Lismore NSW 2480
Country 16267 0
Phone 16267 0
61-2-6620 3643
Fax 16267 0
61-2-6620 3307
Email 16267 0
Contact person for scientific queries
Name 7195 0
Prof Stephen Myers
Address 7195 0
Southern Cross Plant Science
Rifle Range Rd
East Lismore NSW 2480
Country 7195 0
Phone 7195 0
61-2-6620 3643
Fax 7195 0
61-2-6620 3307
Email 7195 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary