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

Kyoto University20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Essential Hypertension

Interventions

Magnetic field generatorDEVICE

dosage:Magnetic field generator Exposure to 1-μT 8/6-Hz ELF-EMF frequency:10min/day duration:1 month

Placebo magnetic field generatorDEVICE

Placebo device with no magnetic fields

Eligibility

Sex: ALLMin age: 20 YearsMax age: 74 Years

Medical Language ↔ Plain English

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

Locations (1)

Kyoto University Hospital

Kyoto, Kyoto, Japan

Outcomes

Primary Outcomes

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).

Time frame: baseline and the end of the exposure regimen (the average of the pre-exposure values for the last two sessions)

Secondary Outcomes

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)

Time frame: 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)

Time frame: for each session

The incidence of adverse events

Time frame: during exposure and at the end of the exposure period and at six months after exposure

Data from ClinicalTrials.gov

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