【ChiCTR-IPR-15005758】電針灸對同時患有經常焦慮症和肚瀉型腸易激綜合症的療效研究

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基本信息

登记号

ChiCTR-IPR-15005758

试验状态

正在进行

药物名称

药物类型

规范名称

首次公示信息日的期

2015-01-02

临床申请受理号

靶点

适应症

comorbid generalized anxiety disorder and diarrhea-predominant irritable bowel syndrome

试验通俗题目

電針灸對同時患有經常焦慮症和肚瀉型腸易激綜合症的療效研究

试验专业题目

電針灸對同時患有經常焦慮症和肚瀉型腸易激綜合症的療效研究

申办单位信息

申请人联系人

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申请人名称

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联系人邮箱

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联系人邮编

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临床试验信息

试验目的

電針灸對同時患有經常焦慮症和肚瀉型腸易激綜合症的療效

试验分类

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试验类型

随机平行对照

试验分期

治疗新技术

随机化

block randomisation

盲法

Randomized

试验项目经费来源

Health and Medical Research Fund

试验范围

目标入组人数

0;74

实际入组人数

第一例入组时间

2015-01-15

试验终止时间

1990-01-01

是否属于一致性

入选标准

1. Rome III criteria for irritable bowel syndrome- diarrheal subtype: (1) Current (weekly) symptoms of type and severity: i. Abdominal pain intensity: weekly average of worst daily (in the past 24 hours) abdominal pain score of at least 1 on 0-4 5-point Likert scale, AND ii. Stool consistency: at least one stool with a consistency of Type 6 or Type 7 Bristol Stool Score in at least 25% of the time. (2) Normal colonic evaluation (colonoscopy or barium enema) within the past 5 years. 2. DSM-5 Criteria for Generalized Anxiety Disorder with GAD7 score 10 or above; 3. Age >18; 4. Provision of written consent.；

排除标准

1. Functional dyspepsia (Rome III definition) and/or Gastro-esophageal reflux disease (Montreal definition) as dominant syndrome; 2. Previous gastrointestinal surgery (except appendicectomy and cholecystectomy); 3. History of organic disease of the gastrointestinal tract, such as colorectal cancer, advanced colonic polyp, celiac disease, inflammatory bowel disease, previous gastrointestinal surgery or systemic diseases that may cause diarrhea; 4. Pregnancy, lactation or not under proper contraception; 5. Concomitant use of anti-diarrheal drugs; 6. History of drug abuse or regular alcohol use in recent 6 months; 7. Active suicidal thoughts or history of violence or suicide attempts; 8. Currently suffering from depression of at least moderate severity (PHQ-9 15 or above); 9. History of severe mental illness, such as psychosis, bipolar disorder, or organic brain syndrome that may limit the response of anxiety and somatic symptoms to electroacupuncture. 10. History of psychotropic drug use or treatment in recent month xi) Currently receiving psychological treatment.；

研究者信息

研究负责人姓名

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试验机构

Department of Medicine and Therapeutics,The Chinese University of Hong Kong

研究负责人电话

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