Safety and Efficacy of JointAlive™ on the Knee-joint Function in Adults With Knee Arthritis
Osteo Arthritis Knee
About this trial
This is an interventional treatment trial for Osteo Arthritis Knee
Eligibility Criteria
Inclusion Criteria:
- Males and females between 40 and 75 years of age, inclusive
- BMI between 18.5 to 29.9 kg/m2, inclusive
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
- Self-reported pain or swelling in target knee
- 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
- Agrees to refrain from taking any pain relievers during the study, except acetaminophen as a rescue medication specified by the study site
- Agrees to refrain from taking rescue medication for 48 hours prior to study visits
- Agrees to maintain current diet and current exercise routine throughout the study
- Willingness to complete questionnaires, records, and diaries associated with the study and to complete all clinic visits
- Provided voluntary, written, informed consent to participate in the study
- Healthy as determined by medical history, laboratory results, and physical exam as assessed by the Qualified Investigator (QI)
Exclusion Criteria:
- Allergy, sensitivity, or intolerance to the investigational product's active or inactive ingredients
- Allergy to rescue medication
- Women who are pregnant, breast feeding, or planning to become pregnant during the study
- Clinically significant abnormal laboratory results at baseline as assessed by the QI
- Individuals who are unable to give informed consent
- Injury in the target knee within the past 3 months
- Intraarticular injections in the target knee within the past 6 months, or plan to have intraarticular injections during the study
- Individuals with knee joint diseases, such as rheumatoid arthritis, gouty arthritis, septic arthritis or any other infective arthritis
- Self-reported history of gout or pseudo gout within the past 6 months
- 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
- 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
- Individuals with muscle or skeletal disorders as assessed by the QI
- Unstable metabolic disease or chronic diseases as assessed by the QI
- In a state of acute exacerbation or seizure of chronic disease
- Type I or Type II diabetes
- 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
- 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
- Current or history of any significant diseases of the gastrointestinal tract including diarrhea or dysentery as assessed by the QI
- 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
- Self-reported confirmation of medical or neuropsychological condition and/or cognitive impairment that, in the QI's opinion, could interfere with study participation
- 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
- Verbal confirmation of blood/bleeding disorders as assessed by the QI
- Individuals with an acute infectious disease, autoimmune disease or are immune-compromised
- Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis
- Current use of prescribed medications listed above
- Current use of over-the-counter medications, supplements, foods and/or drinks listed above
- Use of medical cannabinoid products
- 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
- Alcohol or drug abuse within the last 12 months
- High alcohol intake (average of >2 standard drinks per day)
- Blood donation 30 days prior to screening, during the study, or a planned donation within 30 days of the last study visit
- Participation in other clinical research studies 30 days prior to screening
- 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.
- Oral NSAIDs or topical application on the target knee
- Narcotics
- Oral corticosteroids or topical application on the target knee
- Oral analgesics except acetaminophen as a rescue medication or topical application on the target knee
- Digoxin
- Anti-hypertensive drugs
- Anticoagulants or antiplatelet drugs
- Medications used for OA treatment
- Diazepam
Sites / Locations
- KGK Science Inc
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Placebo
JointAlive™