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The Nutramax test article is a nutritional supplement that contains several ingredients shown to potentially provide benefit to patients suffering from a painful and sometimes debilitating condition of the knee called "osteoarthritis."
This is a pilot study that is intended to determine whether results from a proprietary testing panel conducted on blood and urine samples will correlate with data from physical examination and validated surveys that measure participants' quality of life and physical capabilities.
Full description
Osteoarthritis (OA) of the knee is a significant source of morbidity, especially in patients over the age of 40 and is associated with more than $90 billion in US health care costs annually. While a myriad of clinical interventions are available, the mainstays of OA therapy are the NSAIDs, a class of compounds with well documented side effects including death; the risks of which increase with patient age and chronic use. Assessing the effectiveness of OA treatment modalities is often complicated by a high placebo effect, making purely clinical assessment of outcomes difficult. It is therefore desirable to develop an objective assessment tool for both the diagnosis/staging of knee OA and patient response to interventional therapies.
Participants in this study will receive a formulation of the nutraceutical (test article). They will be asked to take 3 pills at once per day for 40-44 days. There will be either 4 or 5 study visits. If participants have been using certain medications or dietary supplements, they will be asked to return one week from the initial screening, making a total of 5 visits in the study. If they have not been using key medications or dietary supplements, then study activities will begin on the day of the initial screening and they will only have 4 study visits.
Participants will be asked to complete a series of questionnaires about their health, and have their blood drawn (15 mls or about 3 teaspoons), and provide a urine sample at 4 visits. In addition, at the first visit, we will collect information from participants' medical record and they will have a physical exam.
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Inclusion criteria
Exclusion criteria
Subject has any of the following medical conditions:
Subject has a history of cancer (except localized skin cancer without metastases or in situ cervical cancer) within five years prior to screening.
Subject has had a significant injury to the target joint within the past 12 months.
Subject plans to have knee surgery in the next 2 months.
Subject has had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medication.
Subject has an allergy to avocados, soybeans, shellfish or any other ingredient in the test product.
Subject requires additional analgesic or a change from acetaminophen. (Subjects requiring acetaminophen dose adjustments may remain in the study and all such dose and/or schedule changes shall be recorded in the raw data and daily patient diary).
Subject is currently taking any medication or suffers from a medical condition, deemed to potentially interfere with the objectives of the study as determined by the PI.
Subject has a history of drug or alcohol abuse in the past 12 months.
Subject is currently consuming more than 2 standard alcoholic beverages a day. A standard alcoholic beverage is defined as 12 ounces of beer, 5 ounces of wine, or 1.5 ounces of liquor.
Subject does not agree to use a FDA-approved method of birth control or is pregnant, lactating, or planning to become pregnant during the study period.
Subject has any condition or abnormality that, in the opinion of the investigator, would compromise the safety of the subject or the quality of the study data.
Subject is participating or has participated in another research study within 30 days prior to screening.
Subject has used, or intends to use, any oral or injectable NSAID (e.g., ketorolac, aspirin, ibuprofen, naproxen, diclofenac, etc.) within 7 days prior to screening through study completion.
Subject has been treated with oral corticosteroids within 4 weeks prior to screening.
Subject had intra-articular corticosteroids in the target joint within 3 months prior to screening.
Subjects may not take any dietary, vitamin, mineral, or herbal supplements within 7 days prior to Day 0 through study completion. For subjects taking such products at time of the initial visit, a seven-day washout period prior to study Day 1 is allowed EXCEPT for joint health/anti-inflammatory products (see # 18).
Subjects who are currently taking or have taken for ≥ 30 consecutive days OR ≥ 60 days total, within the 180 days prior to screening, dietary products intended to decrease inflammation, body pain and/or improve joint health; including, but not necessarily limited to, glucosamine, chondroitin, avocado-soybean unsaponifiable (ASU), and methylsulfonylmethane (MSM) shall be excluded from the study.
Primary purpose
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9 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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