ACTRN12605000529640已完成1 期
Mechanisms of Action of Glucosamine Hydrochloride / Chondroitin Sulphate (Cosamin¦) and Clinical Response in Osteoarthritis ⿿ a Pilot Study
ature Vet0 个研究点目标入组 25 人开始时间: 2005年9月26日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 85 Years(—)
- 性别
- All
入选标准
- •Subjects with a diagnosis of OA of the hip or knee, with or without other joint involvement, as defined by:i) hip or knee pain while standing, walking and/or in motion of at least 3 months duration, andii) evidence of one or more of the following features in an X-ray picture: osteophytes, osteosclerosis, cysts or joint space narrowing, andiii) a total WOMAC score of 10 or more at study commencementSubjects who have given their informed written consent.Subjects willing to discontinue their current OA treatment for the study duration, commencing at least 4 weeks prior to study commencement. This includes treatment with intra-articular injections, corticosteroids, NSAIDs, non-prescription therapies, chondroprotective agents, occlusive dressings, physiotherapy, or orthopaedic technical measures.Subjects of childbearing age who agree to continue using contraceptive measures for the duration of the study.Subjects with good venous access.
排除标准
- •Severe false alignment of the axis of the knee or hip.Surgery on the knee or hip within the past 2 months or arthroscopy within the past 2 months.Administration of intra-articular injections (e.g. corticosteroids, chondroprotective agents) or treatment with any long acting osteoarthritic therapy in the previous 2 months.Infectious or inflammatory diseases.Female subjects who are pregnant or lactating.Subjects who are unwilling to comply with the study requirements including discontinuation of current osteoarthritis treatment.Subjects with any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objective.Subjects with contra-indications to the study medication or to paracetamol.Reliance on the use of lipolytic, fibrinolytic, anti-coagulant or anti-inflammatory agents or agents that influence platelet function (including but not restricted to - aspirin, aspirin containing compounds and other NSAIDs).A history of trauma associated with the affected joints.Subjects with significant gastrointestinal or renal disease.Subjects with any bleeding disorder.Subjects with a history of alcohol or substance abuse.
研究者
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