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Role of Copper-Albumin Complex in Treatment of Knee Osteoarthritis in Human

2019年1月8日 更新者:Reham I El-mahdy、Assiut University

Role of Copper-Albumin Complex in Treatment of Knee Osteoarthritis in Human:a Pilot Prospective Comparative Study

Osteoarthritis (OA) is one of the most common forms of degenerative joint disease and a major cause of pain and disability affecting the aging population. It is a significant burden in terms of cost as well as the health of society and individuals. Here in our study we will try to evaluate a novel therapeutic method by using topical copper-albumin complexes cream in treatment of osteoarthritis. Then all the biochemical changes will be measured beside the evaluation of topical copper-albumin complexes cream effectiveness in relieving symptoms of the OA.

研究概览

详细说明

Osteoarthritis (OA) is a complex disease process involving the whole synovial joint. In OA articular cartilage is lost through a combination of degenerative and inflammatory phenomena, which are often accompanied by joint swelling, pain, stiffness and loss of joint mobility. The pathogenesis of OA is multifactorial and is considered to be a metabolically active process, predominantly due to the poor regenerative properties of articular cartilage after damage. The most commonly affected joint is the knee, and OA has a higher occurrence in older adults particularly women. Because patients generally present in the clinic after these symptoms of the illness develop, most treatment techniques for OA are designed to address these symptoms rather than cure the underlying disease. Current conservative treatments include lifestyle modification and pain medication (such as NSAIDs) which predominantly treat the illness (e.g., pain symptoms). There is also some promise in the use of chondroitin to decrease joint space narrowing in OA, thus treating the disease itself. Conversely, surgical intervention (partial or total joint replacement) is the preferred treatment method in end-stage disease leading to some relief of both the illness and disease.

Copper complexes can biochemically affect the cells and impinge upon metabolic pathways especially highly effective copper dependent enzymes, such as superoxide dismutase (SOD). It is predicted also that copper containing vitamins or biochemically active organic compounds such as amino acids and peptides or synthetic organic compounds in complexes can effectively scavenge superoxide radical. Additionally, recent studies showed that Cu (II) Bis (diethyldithiocarbamate) induced the expression of syndecan-4, a transmembrane heparan sulfate proteoglycan, in a dose- and time-dependent manner n via the activation of p38 mitogen-activated protein kinase. This submitted work has been designed to evaluate a copper chelating complex consisting of egg albumin and copper as one of the copper peptides that can be used as anti-inflammatory agent and chondroprotective in OA treatment that could be used as a substitute especially the currently used chondroprotective drugs are expensive and frequent using of drugs such as non-steroidal anti-inflammatory drugs (NSAIDs), known to be aggressive agents for gastric ulcer development.

研究类型

观察性的

注册 (预期的)

60

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

40年 至 80年 (成人、年长者)

接受健康志愿者

不适用

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Knee osteoarthritis patients

描述

Inclusion Criteria:

  • Patients of both sexes and over 40 years of age diagnosed with unilateral or bilateral symptomatic OA of the knee who met the criteria of the American College of Rheumatology (ACR).
  • Patients who were rated grade II or III on the Kellgren and Lawrence (K&L) radiological scale [19].
  • Patients with symptomatic OA with a global mean pain in the knee >40 mm on a Visual Analogue Scale (VAS) for pain assessment.

Exclusion Criteria:

  • Women who were pregnant or breastfeeding
  • Patients who were grade I or IV on K&L radiological scale.
  • Patients who have had a prosthesis replaced in the 12 months prior to inclusion.
  • Obesity

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:病例对照
  • 时间观点:预期

队列和干预

团体/队列
干预/治疗
Group I:
Thirty patients with knee osteoarthritis taking topical Copper-Albumin Complex cream
Insulin-Like Growth Factor-1 and Coll2-1 gene expression will be measured by real time PCR. In addition, syndecan 4, hyaluronic acid, substance P and nitric oxide will be measured in plasma by ELISA
Group II:
Thirty patients with knee osteoarthritis taking oral chondroprotective drugs
Insulin-Like Growth Factor-1 and Coll2-1 gene expression will be measured by real time PCR. In addition, syndecan 4, hyaluronic acid, substance P and nitric oxide will be measured in plasma by ELISA

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
The mean difference of syndecan 4 expression and substance P before and after treatment
大体时间:2 months
better understanding the efficacy of the Copper-Albumin Complex treatment for knee osteoarthritis
2 months

次要结果测量

结果测量
措施说明
大体时间
Pain improvement
大体时间:2 months
Visual Analog Score for pain
2 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2019年1月17日

初级完成 (预期的)

2019年3月20日

研究完成 (预期的)

2019年3月30日

研究注册日期

首次提交

2018年11月7日

首先提交符合 QC 标准的

2018年11月7日

首次发布 (实际的)

2018年11月8日

研究记录更新

最后更新发布 (实际的)

2019年1月10日

上次提交的符合 QC 标准的更新

2019年1月8日

最后验证

2019年1月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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