Comparative Efficacy and Tolerability of No7 in Osteoarthritis of the Knee

This is an interventional supportive care trial for Osteoarthritis, Knee Read More

Inclusion Criteria:

• Osteoarthritis (at least 2-nd grade according to Kellgren Classification)
• Ability to walk independently
• Pain Intensity of 4 or more according to Visual Analogue Scale
• NSAIDs usage of 5 times or more per month during 3 months before the intervention
• Ability to understand the benefits and risks of the proposed treatment and can provide answers to the required questions and fill out a questionnaire in Hebrew
• Early consent of participants not to start a new treatment for Osteoarthritis including medication, surgery, physiotherapy, laser therapy, etc. during the period of the study (3 months) - except for a clear medical need (should report to the investigators immediately)

Exclusion Criteria:

• Inflammatory Arthropathy, Severe Rheumatoid Arthritis, Psoriatic Arthritis or Gout
• History of injection of pharmacological material (steroids, anesthetic, hyaluronic acid or any other pharmacological substance) into the knee joint during the six months prior to the start of the study
• Taking of biological drugs that may affect inflammatory conditions (such as anti-TNF- alpha, etc.) or oral PO steroids - even if given to another disease, for more than 5 days during 3 months prior to the start of the study
• Chronic administration of any anti-inflammatory drug during the study period and / or at least one month prior to commencement of the study.
• Chronic administration of medical cannabis
• Use of analgetics in a formulation that provides a half-life of over 24 hours (eg, Butrans, Fentanyl)
• Chronic use of vitamin K antagonists, Heparin, Enoxaparin
• Injury to the knee during six months prior to the experiment
• Expectations of surgical intervention, physiotherapy or other treatment of osteoarthritis before the end of the study period
• Significant irregularities in renal or liver function, active malignant disease in the last 3 years, heart failure, uncontrolled hypertension, active peptic ulcer, hematologic diseases, severe neurological diseases, and mental illness with seizures in the last two years.
• Peripheral neuropathy that treated by any drug
• High alcohol consumption (over 2 standard doses per day)
• Sensitivity to one of the ingredients and / or sensitivity to NSAIDs. It is Possible to include a patient who is sensitive to a specific drug from the family of NSAIDs, but can take other drugs from this family.
• Any medical condition or treatment which, in the opinion of the investigators, may mask the results of the study and / or interfere with the research questions and / or terminate the research properly and / or endanger the participant in any way during the course of the study.