Efficacy and Safety of Weak Extremely Low Frequency Electromagnetic Fields in Mild and Moderate Essential Hypertension

Study Overview
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Brief Summary
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This study will evaluate the efficacy and safety of weak extremely low frequency electromagnetic fields (ELF-EMF) in mild and moderate essential hypertension.

Official Title
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Randomized Placebo-Controlled Trial of Efficacy and Safety of Weak Extremely Low Frequency Electromagnetic Field in Mild and Moderate Essential Hypertension

Conditions
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Essential Hypertension

Intervention / Treatment
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* Device: Magnetic field generator
* Device: Placebo magnetic field generator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1,Exposed to ELF-EMF<br>Device: Magnetic field generator Exposure to 1-μT 8/6-Hz ELF-EMF | Device: Magnetic field generator<br>* dosage:Magnetic field generator Exposure to 1-μT 8/6-Hz ELF-EMF frequency:10min/day duration:1 month<br>|
| Placebo Comparator: 2,Placebo<br>Device: Placebo device with no magnetic fields | Device: Placebo magnetic field generator<br>* Placebo device with no magnetic fields<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). |  | baseline and the end of the exposure regimen (the average of the pre-exposure values for the last two sessions) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |