Clinical trial: Safety and Efficacy of JointAlive™ on the Knee-joint Function in Adults With Knee Arthritis (NCT04395547)

Eligibility criteria:
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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 75 Years

Patient description (medical language): A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee.

Patient description (patient's own words): I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee.

Does the patient match the trial criteria? Entailment