Safety and Efficacy of JointAlive™ on the Knee-joint Function in Adults With Knee Arthritis

This is an interventional treatment trial for Osteo Arthritis Knee Read More

Inclusion Criteria:

1. Males and females between 40 and 75 years of age, inclusive
2. BMI between 18.5 to 29.9 kg/m2, inclusive

3. Female participant is not of child-bearing potential, defined as females who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening Or,

   Females of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:

   • Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
   • Double-barrier method
   • Intrauterine devices
   • Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
   • Vasectomy of partner at least 6 months prior to screening
4. Self-reported pain or swelling in target knee
5. The diagnosis of mild to moderate osteoarthritis as confirmed by the Qualified Investigator using qualifiers based on physical exam, medical history and x-ray report qualified as mild to moderate by the radiologist
6. Agrees to refrain from taking any pain relievers during the study, except acetaminophen as a rescue medication specified by the study site
7. Agrees to refrain from taking rescue medication for 48 hours prior to study visits
8. Agrees to maintain current diet and current exercise routine throughout the study
9. Willingness to complete questionnaires, records, and diaries associated with the study and to complete all clinic visits
10. Provided voluntary, written, informed consent to participate in the study
11. Healthy as determined by medical history, laboratory results, and physical exam as assessed by the Qualified Investigator (QI)

Exclusion Criteria:

1. Allergy, sensitivity, or intolerance to the investigational product's active or inactive ingredients
2. Allergy to rescue medication
3. Women who are pregnant, breast feeding, or planning to become pregnant during the study
4. Clinically significant abnormal laboratory results at baseline as assessed by the QI
5. Individuals who are unable to give informed consent
6. Injury in the target knee within the past 3 months
7. Intraarticular injections in the target knee within the past 6 months, or plan to have intraarticular injections during the study
8. Individuals with knee joint diseases, such as rheumatoid arthritis, gouty arthritis, septic arthritis or any other infective arthritis
9. Self-reported history of gout or pseudo gout within the past 6 months
10. Skin defects (e.g. skin and soft tissue infections that cause necrosis of the skin, or post-burn contractures) and ulcers around the affected knee joint, as assessed by the QI
11. History of knee surgery or replacement in the target knee, or any non-knee surgical procedures that may impact the study outcomes as assessed by the QI
12. Individuals with muscle or skeletal disorders as assessed by the QI
13. Unstable metabolic disease or chronic diseases as assessed by the QI
14. In a state of acute exacerbation or seizure of chronic disease
15. Type I or Type II diabetes
16. History of or current diagnosis with severe cardiopulmonary, kidney and/or liver dysfunctions, with the exception of history of kidney stones in participants who are symptom free for 6 months
17. Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
18. Current or history of any significant diseases of the gastrointestinal tract including diarrhea or dysentery as assessed by the QI
19. Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis
20. Self-reported confirmation of medical or neuropsychological condition and/or cognitive impairment that, in the QI's opinion, could interfere with study participation
21. Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
22. Verbal confirmation of blood/bleeding disorders as assessed by the QI
23. Individuals with an acute infectious disease, autoimmune disease or are immune-compromised
24. Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis
25. Current use of prescribed medications listed above
26. Current use of over-the-counter medications, supplements, foods and/or drinks listed above
27. Use of medical cannabinoid products
28. Chronic use of cannabinoid products (>2 times/week) and is unwilling to stop use for the duration of the study. Occasional use to be assessed by the QI on a case-by-case basis
29. Alcohol or drug abuse within the last 12 months
30. High alcohol intake (average of >2 standard drinks per day)
31. Blood donation 30 days prior to screening, during the study, or a planned donation within 30 days of the last study visit
32. Participation in other clinical research studies 30 days prior to screening
33. Any other condition, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant

Participants on the following concurrent prescribed medications and/or treatments will be excluded during enrollment unless they have been taken off these therapies by their family physician. In the latter event, the frequency and route of administration of use and/or dosage may be considered by the QI on a case-by-case basis prior to recommending an appropriate washout or their enrollment in the study.

1. Oral NSAIDs or topical application on the target knee
2. Narcotics
3. Oral corticosteroids or topical application on the target knee
4. Oral analgesics except acetaminophen as a rescue medication or topical application on the target knee
5. Digoxin
6. Anti-hypertensive drugs
7. Anticoagulants or antiplatelet drugs
8. Medications used for OA treatment
9. Diazepam