A Randomised Controlled Trial of a Marinova Seaweed Extract on Osteoarthritis

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).

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000654752

Enrollment

130

Registered

2013-06-14

Start date

2011-08-19

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

500mg capsule taken orally twice daily containing 150mg Fucus vesiculosis (seaweed) extract and 350mg Microcrystaline Cellulose (MCC) for 12 weeks.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Healthy volunteers

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.

Exclusion criteria

A history of trauma associated with the affected joint. Rheumatoid or other inflammatory joint conditions. Gout. 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.

Outcome results