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

Kyoto University1 site in 1 country20 target enrollmentDecember 2007

ConditionsEssential Hypertension

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Essential Hypertension
Sponsor: Kyoto University
Enrollment: 20
Locations: 1
Primary Endpoint: 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).
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2007

End Date

December 2008

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Kyoto University

Eligibility Criteria

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

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)(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)