A Clinical Study to Evaluate the Efficacy of Native CT-II® in Individuals With Knee Osteoarthritis

Exclusion Criteria

• •1.Individuals who have been injured near the knee joint region in the past six months.
• •2.Individuals with a history of knee surgery, replacement or any non-knee surgical procedures that may impact the study outcomes.
• •3.Individuals who have used intra-articular injections, platelet replacement therapy, stem cell therapy and or steroids for joint health issues in the last six months.
• •4.Individuals who have any other chronic disease or condition, or inflammatory disease conditions and/ or are using any medication or dietary supplements or ayurvedic medications or topical ointment/oil/gel for joint health that in the judgment of the Investigator would put the individual at unacceptable risk for an individual in the study or may interfere with evaluations in the study or noncompliance with treatment or visits.
• •5.History or presence of clinically significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic, or neurological disorders, that in the judgment of the Investigator, would interfere with the individual's ability to provide informed consent, comply with the study protocol (which might confound the interpretation of the study results), or put the individual at undue risk.
• •6.History of uncontrolled hypertension and/or systolic blood pressure more than or equal to 140 mmHg and/or diastolic blood pressure more than or equal to 90 mmHg.
• •7.Fasting blood glucose (FBG) more than or equal to 126 mg/dl 8.Known cases of gout and/or hyperuricemia 9.Any history or evidence of allergy to chicken, shellfish, eggs or protein products in the past.
• •10.Use of collagen supplements (as dietary supplements) 11.History of bleeding disorders (e.g. Hemophilia, sickle cell anemia) 12.Other pathologic lesions on X-ray of the knee. 13.Any other condition that would prohibit completion of the exercise protocols.
• •14.Individuals who have participated in a clinical study with an Investigational product within 90 days before pre-screening, and who plan to participate in another study during the study period.
• •15.Not willing to abstain from the use of NSAIDs (including aspirin 50 mg/day for cardiovascular health).
• •16.Pregnant or Lactating females. 17.Individuals having a history of drug or alcohol abuse. 18.Current smokers