Status:
COMPLETED
NEM® + BIOCURC® Versus Placebo in Exercised-induced Joint Pain, Stiffness, & Cartilage Turnover in Healthy Men & Women
Lead Sponsor:
ESM Technologies, LLC
Collaborating Sponsors:
QPS Bio-Kinetic
Conditions:
Exercise-induced Joint Pain
Exercise-induced Joint Stiffness
Eligibility:
All Genders
40-75 years
Phase:
NA
Brief Summary
This study is intended to evaluate the combined effects of the dietary supplement NEM® brand eggshell membrane and BIOCURC® brand bioavailable curcumin versus placebo in reducing exercise-induced join...
Detailed Description
Moderate exercise can induce discomfort in joints when done infrequently or when done too intensely or for too long a period. This discomfort is often realized as either pain or stiffness in the joint...
Eligibility Criteria
Inclusion
- Male or Female subjects must be 40-75 years of age at the time of Screening.
- Subjects must not have been diagnosed with a JCT disease (i.e. osteoarthritis, rheumatoid arthritis, spondyloarthritis, bursitis, gout, systemic lupus erythematosus, fibromyalgia, etc.) affecting the hip, knee, or ankle by a licensed physician prior to enrollment evaluation / screening.
- Subjects must have a resting pain/discomfort score of ≤ 2 on the 10-point continuous scale in the knee with the most severe pain/discomfort at the Follow-Up Screening/Baseline (first exercise visit).
- Subjects must be willing and healthy enough, as judged by the clinical Investigator or Sub-Investigator(s), to perform moderate exercise.
- Subjects must be available for and willing to attend all evaluation visits.
- Subjects must be able and willing to give informed consent.
- Subjects must be willing to use only acetaminophen as rescue pain medication, if needed.
- Subjects participating in prior studies evaluating eggshell membrane, curcumin, fish oil or collagen can participate in the present study so long as they are not currently taking an eggshell membrane, fish oil, curcumin, or collagen supplement and have not done so for 60 days prior to screening.
Exclusion
- Subject is currently receiving therapy with remission-inducing drugs (i.e. methotrexate, TNF biologics, etc.), immunosuppressive drugs (i.e. corticosteroids, transplantation medications, etc.) or planning to use these products during the study period.
- Subject has been diagnosed with any clinically significant confounding inflammatory disease or condition that would interfere with the study evaluation, as judged by the clinical investigator (i.e. pseudo gout, Paget's disease, chronic pain syndrome, active rheumatic fever, etc.).
- Subject has known allergy to any of the investigational products, including but not limited to eggs or egg products and rice or rice flour. If any subject becomes sensitive during the study, they will immediately be excluded from continuing in the study.
- Subject suffers from clinically significant cardiac, pulmonary, or other complications that would prevent them from performing moderate exercise or could pose a risk to the subject's health, as judged by the clinical investigator.
- Subject participates in activities involving intensive use of the lower extremities (i.e. running / jogging, sports, bicycling, dancing, etc.) 2 or more days per week or participates in activities that involve moderate use of the lower extremities (i.e. walking, golfing, yoga, etc.) 3 or more days per week.
- Subject's body weight is greater than 300 pounds (136.1 kg) at the time of Screening.
- Subject is currently taking or is unwilling to forgo the use of prescription, over-the-counter (OTC) treatments, and/or dietary supplements affecting joint health within 30 days prior to baseline evaluation and for the duration of the study. Prohibited medications include: NSAIDs, analgesics (other than acetaminophen), opioids, anti-depressants (of all drug classes for this indication, including but not limited to SSRI's such as citalopram and fluoxetine, TCA's such as amitriptyline and amoxapine, SNRI's such as duloxetine or SNRI's used for fibromyalgia such as milnacipran and NDRI's such as bupropion), other medications for the management of painful conditions (i.e. fibromyalgia) including gabapentin and tizanidine \& joint supplements. Examples of these types of medications are: aspirin, ibuprofen, naproxen, oxycodone, propoxyphene, diclofenac, celecoxib, amitriptyline, duloxetine, glucosamine, chondroitin, MSM, white willow bark, turmeric or curcumin, Boswellia, fish oil, etc.
- a. Washout Periods: Subjects are eligible to participate in the study following a 7-day washout period for opioids, a 14-day washout period for analgesics \& NSAIDs, and a 90-day washout period for steroids, anti-depressants, or JCT dietary supplements (i.e. glucosamine, chondroitin, MSM, etc.) Acetaminophen must not have been taken within 24 hours of the first baseline evaluation.
- Subject is involved in any other research study involving an investigational product (drug, device or biologic) or a new application of an approved product, within 30 days of the first baseline evaluation.
- Pregnant and breastfeeding women, or women who intend to become pregnant during the course of the study.
- Subject has a history or positive test result of HIV, hepatitis B or hepatitis C.
Key Trial Info
Start Date :
January 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2019
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT03769857
Start Date
January 13 2019
End Date
April 15 2019
Last Update
July 18 2019
Active Locations (1)
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1
QPS Bio-Kinetic
Springfield, Missouri, United States, 65802