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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00709930

Enrollment

Registered

2008-07-03

Start date

2007-12-31

Completion date

2008-12-31

Last updated

2009-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential Hypertension

Brief summary

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

Interventions

DEVICEMagnetic field generator

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

DEVICEPlacebo magnetic field generator

Placebo device with no magnetic fields

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 74 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026