NCT00709930已完成2 期
Randomized Placebo-Controlled Trial of Efficacy and Safety of Weak Extremely Low Frequency Electromagnetic Field in Mild and Moderate Essential Hypertension
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The difference between the ELF-EMF and sham groups with respect to the absolute change in SBP value between baseline and the end of the exposure regimen (the age of the pre-exposure values for the last two sessions).
研究概览
简要总结
This study will evaluate the efficacy and safety of weak extremely low frequency electromagnetic fields (ELF-EMF) in mild and moderate essential hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages: 20 years to 74 years
- •Genders : Both
- •The severity of hypertension: mild and moderate (WHO/ISH criteria stage I-II) Systolic blood pressure (SBP) >/= 140 and/or diastolic blood pressure (DBP)>/= 90 (untreated hypertension cases)
排除标准
- •Any of the following medical conditions:
- •Severe essential hypertension (DBP >110)
- •Secondary or malignant hypertension
- •History or symptoms of cerebral vascular disease
- •History of myocardial infarction
- •History of angina pectoris, atrial fibrillation, heart failure and arrhythmia
- •Renal dysfunction (serum creatinine > 2.1mg/dl)
- •Severe hepatic dysfunction
- •Uncontrolled diabetes
- •Allergy, drug sensitivity or chronic skin disease
- •Peptic ulcer disease
- •Current pregnancy or lactation
- •Depression that needs to be treated
- •Hypertension controlled with antihypertensive medication
研究组 & 干预措施
1,Exposed to ELF-EMF
Active Comparator
Device: Magnetic field generator Exposure to 1-μT 8/6-Hz ELF-EMF
干预措施: Magnetic field generator (Device)
2,Placebo
Placebo Comparator
Device: Placebo device with no magnetic fields
干预措施: Placebo magnetic field generator (Device)
结局指标
主要结局
The difference between the ELF-EMF and sham groups with respect to the absolute change in SBP value between baseline and the end of the exposure regimen (the age of the pre-exposure values for the last two sessions).
时间窗: baseline and the end of the exposure regimen (the average of the pre-exposure values for the last two sessions)
次要结局
- The difference between the ELF-EMF and sham groups with respect to the change in DBP value between baseline and the end of the exposure regimen (the average of the pre-exposure values for the last two sessions)(baseline and the end of the exposure regimen (the average of the pre-exposure values for the last two sessions))
- The change in both SBP and DBP values between pre-exposure and post-exposure for each session (averaged over the regimen)(for each session)
- The incidence of adverse events(during exposure and at the end of the exposure period and at six months after exposure)
研究者
研究点 (1)
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