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【ChiCTR-OIC-17010625】先導計劃 - 研究富血小板血漿注射治療退化性膝關節炎

基本信息
登记号

ChiCTR-OIC-17010625

试验状态

结束

药物名称

/

药物类型

/

规范名称

/

首次公示信息日的期

2017-02-02

临床申请受理号

/

靶点

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适应症

退化性膝關節炎

试验通俗题目

先導計劃 - 研究富血小板血漿注射治療退化性膝關節炎

试验专业题目

先導計劃 - 研究富血小板血漿注射治療退化性膝關節炎

申办单位信息
申请人联系人
申请人名称
联系人邮箱
联系人邮编

联系人通讯地址
临床试验信息
试验目的

研究富血小板血漿注射治療退化性膝關節炎

试验分类
试验类型

单臂

试验分期

Ⅱ期

随机化

NA

盲法

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试验项目经费来源

NA

试验范围

/

目标入组人数

12

实际入组人数

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第一例入组时间

1990-01-01

试验终止时间

1990-01-01

是否属于一致性

/

入选标准

1) Aged 45 to 75 years old; 2) Self-reported symptoms consistent with KOA per American College of Rheumatology guidelines; 3) Have experienced moderate to severe knee pain for at least 3 months, defined as a score of 3 or more (0-6 ordinal response scale) on the question "What is the average level of your left/right knee pain?" 4) Failed 6 months of usual care; 5) Clinical evidence of KOA according to the American College of Rheumatology guidelines; 6) Radiographic evidence of KOA with Kellgren Lawerance (KL).;

排除标准

1) Pregnancy; 2) On anticoagulation, immunosuppressive or daily opioid therapy; 3) History of collagen tissue or other autoimmune disorders; 4) Hematological diseases; 5) Severe cardiovascular diseases; 6) Prior or planned total knee replacement of the affected knee; 7) Allergy or intolerance to acetaminophen or xylocaine; 8) Body mass index (BMI) ≥ 35 kg/m2; 9) Co-morbidity severe enough to prevent reliable or safe study participation; 10) Subjects who cannot read or write in the Chinese Consent form; 11) Interim knee joint infectious arthritis or trauma; 12) Hemoglobin level < 11g/dL; 13) Platelet concentration < 150,000/mm3; 14) Clinical examination suggesting that the patient is not appropriate due to comorbid knee or other conditions.;

研究者信息
研究负责人姓名
试验机构

The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong

研究负责人电话
研究负责人邮箱
研究负责人邮编

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联系人通讯地址
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