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【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

药物类型

规范名称

首次公示信息日的期

2014-02-17

临床申请受理号

靶点

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

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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

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试验类型

随机交叉对照

试验分期

Ⅱ期

随机化

Block randomization

盲法

试验项目经费来源

National Research Council of Thailand (NRCT)

试验范围

目标入组人数

实际入组人数

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

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

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试验机构

National Research Council of Thailand (NRCT)

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