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

Kyoto University

Status and phase: Completed; Phase 2

Conditions: Essential Hypertension

Treatments: Device: Placebo magnetic field generator; Device: Magnetic field generator

Study type: Interventional

Funder types: Other

Identifiers

NCT00709930

MF-II-01

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 20 to 74 years old

Volunteers: No 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

Trial design

20 participants in 2 patient groups, including a placebo group

1,Exposed to ELF-EMF

Active Comparator group

Description:

Device: Magnetic field generator Exposure to 1-μT 8/6-Hz ELF-EMF

Treatment:

Device: Magnetic field generator

2,Placebo

Placebo Comparator group

Description:

Device: Placebo device with no magnetic fields

Treatment:

Device: Placebo magnetic field generator