Phase
Condition
Arthritis And Arthritic Pain
Arthritis And Arthritic Pain (Pediatric)
Rheumatoid Arthritis
Treatment
N/AClinical Study ID
Ages 18-80 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subjects must be able and willing to give Informed Consent.
Subjects must not have taken anti-inflammatory drugs or supplements for 5 days priorto their initial C-RP blood test, and must refrain from taking these products for theduration of the study.
Subjects will be required to refrain from taking other pain-reducing agents during thecourse of the study. This will ensure that the effects observed in the study are theeffects of the supplement only, and not of other anti-inflammatory agents
Subjects must have had knee or hip joint or muscle pain on most days of the previousmonth; should not have "morning stiffness" for more than 30 minutes; and shouldexperience "stiffness" after resting.
Subjects must have persistent pain in the knee or hip joints or connective tissue witha pain assessment score of at least 5, but not more than 9 using the WOMAC PainAssessment and Pain Intensity Rating scale.
Subjects must be available for and willing to attend all evaluation visits.
Subjects must be willing to take/use the test Krill Oil compositions in place ofcurrent pain relief medications.
Subjects may not be on any steroid-based therapies.
Subjects must have access to a telephone for calling into the Clinical Center as partof test product compliance.
Subjects must be willing to use appropriate birth control for duration of trial (ifappropriate)
Subjects must be willing to limit consumption of fatty fish for one week prior to andduring the study
Subjects must be willing to refrain from taking any other nutritional supplementsrelated to immune function or pain reduction during the course of this study.
Exclusion
Exclusion Criteria:
Subjects must not be taking remission-inducing drugs such as methotrexate.
Subjects whose joint pain is not in their knees.
Subjects who are not willing to forego the use of anti-inflammatory and anti-painmedications or supplements for the duration of the study.
Subjects who know that their joint pain is due to osteoarthritis or rheumatoidarthritis.
Women who are pregnant, breastfeeding, or planning to become pregnant during the
course of the trial
Clinical evidence or known history of severe cardiac, pulmonary, gastrointestinal,renal, hepatic or neurological disorders.
History of allergy to aspirin or NSAlDs.
Subjects who have undergone total knee replacement in the contra-lateral knee within 6months prior to the screening visit.
Subjects who have received an intra-articular corticosteroid injection in a lowerjoint during the three (3) months prior to the baseline visit.
Subjects with isolated lateral compartment disease defined by joint space loss in thelateral compartment only.
Subjects who have received chondrocyte transplants in any lower extremity joint.
Subjects with co-morbid conditions that restrict knee function.
Treatment with corticosteroids before washout period
Patients with infectious arthritis or gout
Unstable medical conditions.
Use of omega fatty acid supplements within two weeks of this study
Clinically significant abnormal laboratory results at baseline
Participation in a clinical research trial within 30 days prior to randomization
Allergy, especially from crustaceans, or sensitivity to study supplement ingredients
Individuals cognitively impaired and/or who are unable to give Informed Consent
Any other health or mental condition that in the Investigator's opinion may adverselyaffect the subject's ability to complete the study or its measures or that may posesignificant risk to the subject
Subjects taking Inflammatory medications, cardiovascular medications, hypotensivemedications, blood thinners
Presence of auto immune diseases, other diseases of the immune systems,
gastrointestinal diseases, i.e. Irritable bowel syndrome, or disorders of lipidmetabolism.
Study Design
Connect with a study center
1621 Bridgeway
Sausalito, California 94965
United StatesSite Not Available

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