NCT03442153Unknown不适用
Comparative Efficacy and Tolerability of No7 in Osteoarthritis of the Knee: A Double Blind, Randomized, Placebo Controlled Clinical Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 76
- 主要终点
- Pain Intensity
研究概览
简要总结
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.
详细描述
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 components of the product were effective in some studies in relieving pain and inflammation in such patients. This Study evaluates the effect of these components as a complex.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
Solgar No7
Experimental
Aflapin 100 mg and Collagen UC2 40 mg by mouth every 24 hours for 90 days
干预措施: Solgar No7 Complex (Dietary Supplement)
Placebo for Solgar No7
Placebo Comparator
Placebo 1 Capsule by mouth, every 24 hours for 90 days
干预措施: placebo (Dietary Supplement)
结局指标
主要结局
Pain Intensity
时间窗: Pain intensity Reported to the Doctor after one month of the treatment. Each item is scored 0-10 (0=no pain; 10=pain as bad as can be), yielding a total between 0 and 30.
Self reported pain intensity in the scale 1-10
次要结局
- Adverse Reactions(Adverse Reactions as Reported to the Doctor over the period of the treatment. Each item is scored as a number of the dose units that were used during the all period (0=no adverse reactions, 1=only one adverse reaction etc))
- Knee Stiffness(nee Stiffness checked by the Doctor after one month of treatment. Each item is scored 0-10 (0=no pain; 10=pain as bad as can be), yielding a total between 0 and 30)
- Non Steroidal Anti Inflammatory Drugs Usage(Pain Medication Usage as Reported to the Doctor after one month of treatment. Each item is scored as a number of the dose units that were used during the all period (0=no medications, 1=only one dose of medication etc))
研究者
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