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首页 临床进展 Effects of Acute Electroacupuncture Therapy Versus Transcutaneous Electrical Nerve Stimulation as Adjunctive Treatment for Sudden Sensorineural Hearing Loss: A Preliminary Study

【ChiCTR-TTRCC-14004275】Effects of Acute Electroacupuncture Therapy Versus Transcutaneous Electrical Nerve Stimulation as Adjunctive Treatment for Sudden Sensorineural Hearing Loss: A Preliminary Study

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基本信息
登记号

ChiCTR-TTRCC-14004275

试验状态

结束

药物名称

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药物类型

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规范名称

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首次公示信息日的期

2014-02-17

临床申请受理号

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靶点

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适应症

Sudden sensorineural hearing loss

试验通俗题目

Effects of Acute Electroacupuncture Therapy Versus Transcutaneous Electrical Nerve Stimulation as Adjunctive Treatment for Sudden Sensorineural Hearing Loss: A Preliminary Study

试验专业题目

Effects of Acute Electroacupuncture Therapy Versus Transcutaneous Electrical Nerve Stimulation as Adjunctive Treatment for Sudden Sensorineural Hearing Loss: A Preliminary Study

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

To evaluate the effects of Electroacupuncture (EA) and compare its therapeutic efficacy to Trancutaneous electrical nerve stimulation(TENS) and conventional medical therapy in cases of ISSHL

试验分类
试验类型

随机交叉对照

试验分期

Ⅱ期

随机化

Block randomization

盲法

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试验项目经费来源

National Research Council of Thailand (NRCT)

试验范围

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目标入组人数

40

实际入组人数

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第一例入组时间

2012-06-26

试验终止时间

2014-01-31

是否属于一致性

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入选标准

1. Male or female, age > 18 to 80 years and legal age of consent; 2. Has diagnosis of first episode of unilateral sudden sensorineural hearing loss; 3. Audiogram shows sensorineural hearing loss > 30 dB at least 1 frequency of the affected ear, and if the subject is older than 50 years old; the hearing threshold of the contralateral ear must be 10 dB less the affected ear.；

排除标准

1. History of head injury, loud noise exposure, use of ototoxic drugs, infections of middle ears, brain infections; 2. History of coagulation defects or receive anticoagulants/ antiplatelets; 3. History of epilepsy, seizure, stroke, cerebral ischemia, or has cardiac pacemakers; 4. Immunocompromised status, including a debilitated state or Malignancy; 5. Physical examination and laboratory results reveal following findings: Vesicles at pinna, ear canal, or tympanic membrane/ Perforated tympanic membrane/ Fluid in middle ear space/ CNS abnormality/ Abnormal VDRL or TPHA/ Significant prolonged PT, PTT, INR; 6. MRI or CT scan shows structural abnormality of brain and auditory nerve; 7. Lack of ability or willingness to give informed consent.；

研究者信息
研究负责人姓名
试验机构

National Research Council of Thailand (NRCT)

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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