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

March 30, 2009 updated by: Kyoto University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kyoto, Japan, 606-8507
        • Kyoto University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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).
Time Frame: 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)

Secondary Outcome Measures

Outcome 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)
Time Frame: 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)
Time Frame: for each session
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
during exposure and at the end of the exposure period and at six months after exposure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyoto University

Investigators

  • Principal Investigator: Masanori Fukushima, Kyoto University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

June 27, 2008

First Submitted That Met QC Criteria

July 1, 2008

First Posted (Estimate)

July 3, 2008

Study Record Updates

Last Update Posted (Estimate)

March 31, 2009

Last Update Submitted That Met QC Criteria

March 30, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MF-II-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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