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).

Marinova Pty Ltd0 个研究点目标入组 130 人开始时间: 2013年6月14日最近更新: 2020年1月13日

适应症

试验速览

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•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.

•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.

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