Status:
COMPLETED
Effects of Aquamin F on Osteoarthritis of the Knee
Lead Sponsor:
Marigot Ltd.
Conditions:
Osteoarthritis of the Knee
Eligibility:
All Genders
35-75 years
Phase:
PHASE1
PHASE2
Brief Summary
The objective of this trial is to evaluate the effect of Aquamin F alone or in combination with glucosamine sulfate versus placebo on symptoms of joint pain, stiffness and immobility in subjects with ...
Detailed Description
Method: Subjects were randomized to receive 12 weeks of Glucosamine sulfate vs Aquamin F vs Placebo vs Aquamin F + Glucosamine sulfate while controlling for pain with acetaminophen. Subjects were then...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Subjects aged 35 to 75, male or female
- Subjects diagnosed with symptomatic moderate to severe osteoarthritis of the knee according to the modified criteria of the American College of Rheumatology17, 18
- Subjects who present with osteoarthritis of the knee as judged by symptoms and disabilities detectable through published, validated questionnaires or previous diagnosis by a physician.
- Subjects who are symptomatic with daily or near daily pain and stiffness from osteoarthritis.
- Subjects with screening WOMAC Osteoarthritis Index total score (transformed score) of not more than 75.
- Subjects with ability to comprehend and complete the questionnaires and forms.
- Subjects whose schedules permit clinic evaluations every four weeks.
- Subjects who are willing to stop taking calcium supplements, if any, and to restrict consumption of high calcium foods to 600 mg (two dairy serving) per day
- Subjects with a high probability of compliance with study procedures and test article consumption.
- Subjects willing and able to follow protocol guidelines and schedules, and complete diaries.
- Subjects who are likely to abstain from taking unauthorized supplements or participating in any other clinical trial or experimental treatment during this trial
- Subjects with normal gastrointestinal digestion and absorption.
- Exclusion Criteria
- Subjects suffering from inflammatory arthritis, gout, pseudogout, Paget's disease, seizure disorder, insulin dependent diabetes mellitus, uncontrolled hypertension, unstable cardiovascular disease, active hepatic or renal disease, active cancer and/or HIV infection.
- Subjects who are non-ambulatory or bedridden due to osteoarthritis.
- Subjects who are dependent on prescription drugs to control pain.
- Subjects on any other clinical trial or experimental treatment in the past 3 months
- Subjects who are pregnant, lactating, or at risk of becoming pregnant.
- Subjects who have received:
- Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) within 48 hours prior to study enrollment.
- Intramuscular or systemic corticosteroid injection within 4 weeks prior to study enrollment.
- Intra-articular corticosteroid injection within 2 months prior to study enrollment.
- Intra-articular hyaluronic acid injection within 4 months prior to study enrollment.
Exclusion
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00452101
Start Date
January 1 2006
End Date
December 1 2006
Last Update
March 26 2007
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