【ChiCTR-INR-16010048】針刺治療膀胱過度活躍症的臨床試驗研究

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基本信息

登记号

ChiCTR-INR-16010048

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

2016-11-29

临床申请受理号

靶点

适应症

膀胱過度活躍症

试验通俗题目

針刺治療膀胱過度活躍症的臨床試驗研究

试验专业题目

針刺治療膀胱過度活躍症的臨床試驗研究

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

1) to evaluate the effectiveness of acupuncture treatment for patients with OAB on the reduction of the frequency of incontinence episodes as derived from 7-day voiding diary; 2) to evaluate whether acupuncture treatment could improve the subjective symptoms in patients with OAB.

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

using a computer program (Random Allocation Software, version 1.0; Msaghaei) to generate random numbers. The list of randomization number will be kept by a research staff member who will be responsible for assigning the corresponding intervention code based on the list to the recruited patients.

盲法

Double blind

试验项目经费来源

Health and Medical Research Fund

试验范围

目标入组人数

100

实际入组人数

第一例入组时间

2017-03-01

试验终止时间

2018-08-31

是否属于一致性

入选标准

Both male and female elderly at the age between 60 to 90 years old; Diagnosed as OAB wet-type (3 or more episodes of incontinence in the past 4 weeks that are no stress-incontinence) according to the diagnosis criteria of the ICS;Physically and mentally able to complete the 7-day voiding diary, Urinary Distress Inventory (UDI-6) and Incontinence Impact questionnaire (IIQ7) Able to give written inform consent (by patients themselves or by caretaker).；

排除标准

OAB symptom caused by stroke or spinal injury; Life threatening infection; Unconsciousness or severe cognition deficits; Dementia caused by Alzheimer’s disease or other neurodegenerative diseases; Undergone incontinence surgery previously; On short-term active diuretic treatment or taking diuretic medication; Had previously received acupuncture treatment for any medical conditions; Patients who are on drug treatment for OAB; Patients who diagnosed as stress urinary incontinence; Pregnancy; Suffering the following diseases: untreated urinary tract infection, urogenital tumors, prostate tumor, benign prostatic hyperplasia, chronic urinary retention.；

研究者信息

研究负责人姓名

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试验机构

The Chinese University of Hong Kong

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研究负责人邮编

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