Phase
Condition
Arthritis And Arthritic Pain
Chronic Pain
Rheumatoid Arthritis
Treatment
Placebo
Native type II collagen
Clinical Study ID
Ages 30-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Males and non-pregnant females 30-65 years old with a Body Mass Index (BMI) ofapproximately 18 to 30 kg/m2. (see Section 4.0)
Unilateral or bilateral knee discomfort for greater than 3 months.
VAS score during knee movement between 30-50 mm after 7-day withdrawal of excludedmedications.
Reach joint discomfort of 5/10 on a 11-point Likert scale ( score 0 to 10) within 10minutes of going up and down stairs.
Clinical laboratory results that are within normal range or considered notclinically significant by the Principal Investigator.
Be willing to participate in all scheduled visits, tests, and other trial proceduresaccording to the clinical protocol. To do so and be able of using the fitnesstracker, a phone or tablet compatible with the Fitbit app is required. (Apple iOS 12.2 or higher, Android OS 7.0 or higher.)
Be willing to refrain from taking ibuprofen, aspirin or other Non-steroidalanti-inflammatory drugs (NSAIDs), or any other pain reliever (OTC (Over the Counter)or prescription) during the entire study other than acetaminophen (paracetamol) asrescue medication.
Provide a signed and dated informed consent indicating that the subject has beeninformed of all pertinent aspects and possible risks associated with participationin the study.
Be willing to refrain from taking dietary supplements during the entire study thathave any underlying joint benefit (collagen, glucosamine, chondroitin, MSM,Hyaluronic Acid, Turmeric, Natural Eggshell Membrane, Omega-3 fatty acids, PEA,Boswellia,...)
Exclusion
Exclusion Criteria:
History of hypersensitivity to the rescue medication or any of the products used inthe study.
Requirement of drugs to control joint discomfort.
Regular drug intake to control any kind of pain.
History of hypersensitivity to eggs, chicken, or fowl.
History of Knee OA (OsteoArthritis), inflammatory arthropathy, RA (RheumatoidArthritis), OA (VAS score greater than 50), or Systemic Lupus Erythematosus.
Hyperuricemia (>440 μmol/L), history of gout, or both.
Exercising (intentionally) for more than 10 hours a week
High intensity exercise for more than 5 hours a week
Anticipation of surgery within the next 6 months.
Recent injury in the target knee (past 4 months).
History of congestive heart failure.
Anticipated problems with product consumption.
Evidence or history of clinically significant haematological, renal, endocrine,pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, ormalignancies within the last 5 years.
High alcohol intake (>2 standard drinks per day) or use of recreational drugs (e.g.,cocaine, methamphetamine, marijuana, etc.).
Females who are pregnant or lactating or planning to become pregnant.
History of any mental illness that might impair the ability of subjects to provide awritten informed consent.
Use of oral corticosteroid, indomethacin, SYSADOAs (symptomatic slow action drugosteoarthritis) within 3 months of Visit 1; topical treatment with corticosteroidswithin 1 week of visit 1, and consumption of Omega 3 fatty acids or any other jointhealth dietary supplements within 2 weeks preceding the treatment period.
Consumed, ibuprofen, aspirin or other NSAIDS, or any other pain reliever (OTC orprescription), or any natural health product, (excluding vitamins) within 7 days offirst visit.
Consumed acetaminophen (paracetamol) within 48 hours of randomization visit.
Participation in any clinical trials within 30 days prior to first visit.
Individuals following an energy restricted diet for weight loss
Study Design
Study Description
Connect with a study center
Instituto Poal de Reumatología
Barcelona,
SpainSite Not Available
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