Status:
UNKNOWN
Comparative Efficacy and Tolerability of No7 in Osteoarthritis of the Knee
Lead Sponsor:
Ambrosia - SupHerb Ltd.
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
45-75 years
Phase:
NA
Brief Summary
This study evaluates the effect of dietary supplement Solgar No7 in 76 adult Osteoarthritis of the Knee Patients, while the other half will receive placebo.
Detailed Description
Solgar No7 is a Dietary Supplement marketed in Israel on a regular basis with the approval of the Israeli Ministry of Health. The product is based on Herbal Extracts and Vitamins. The individual compo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2018
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT03442153
Start Date
March 1 2018
End Date
May 1 2018
Last Update
February 22 2018
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