DRKS00009034已完成未知
Placebo-controlled, randomized double-blind study to evaluate the efficacy and tolerability of Rosaxan® in patients with Gonarthrosis - MEA/008915
medAgil Gesundheitsgesellschaft mbH0 个研究点目标入组 92 人开始时间: 2016年1月25日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 92
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 30 Years 至 70 Years（—）
- 性别
- All
入选标准
- •clinically diagnosed Gonarthrosis one or both knees with: o moderate pain symptoms [4-8 points as the average of the WOMAC pain index]
- •neg. Pregnancy test (ß HCG) prior inclusion of child-bearing women
- •contraceptive protection for child-bearing women
排除标准
- •Knee pain or functional limitation of the knee joint other cause • Threat of disability • Known allergies and / or sensitivities to components of the investigational product • Major organic and / or systemic diseases that are unacceptable to continue the participation from investigator view • ingestion (during the study) of: • dietary supplements such as vitamin supplements
- •Complementary balanced diets • anti-inflammatory plant extracts like e.g. Devil's Claw • enzyme preparations such as Wobenzym® • mineral products, protein hydrolysates, Amino acid concentrates • chondroprotectives (cartilage protection products as e.g. Glucosamine, chondroitin sulfate, collagen Hydrolyzate, gelatin, hyaluronic acid, Methylsulfonylmethane)
- •Fish oil capsules (omega 3 fatty acid capsules) • treatment with cartilage protection products in the last 3 Months and during the study • treatment during the study (oral ingestion, injection, topical application) with steroidal and non- Antirheumatic drugs with the exception of: Acetylsalicylic acid (ASA, aspirin), diclofenac (Voltaren example) and Paracetamol
- •Cortisone treatment in the last 3 weeks and during the study
- •Administration of opioid analgesics, • pregnancy or lactation • medication, alcohol and / or drug abuse • peripheral arterial occlusive disease (PAOD) • acute meniscus injuries Rheumatoid arthritis • infection-associated arthritis • Bony injuries of the lower extremities (eg Femoral neck fracture) in the last 12 months • herniated disc • Arthroscopic surgery of the knee joint in the last 6 months and during the study
- •Concomitant treatment of osteoarthritis of the knee with Magnetic therapy, shockwave therapy, acupuncture during study
- •Signs that the patient is unable to comply with the protocol (eg, lack of cooperation) • Simultaneous participation in another clinical trial or participation in such within the last 6 weeks • Dependence / working relationship with the sponsor or investigator
研究者
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