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

Essential Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00709930
• Other study ID #: MF-II-01
• Status: Completed
• Phase: Phase 2
• First received: June 27, 2008
• Last updated: March 30, 2009
• Start date: December 2007
• Est. completion date: December 2008

Study information

• Verified date: March 2009
• Source: Kyoto University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 74 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Device:
• Magnetic field generator
dosage:Magnetic field generator Exposure to 1-µT 8/6-Hz ELF-EMF frequency:10min/day duration:1 month
• Placebo magnetic field generator
Placebo device with no magnetic fields

Locations

Country	Name	City	State
Japan	Kyoto University Hospital	Kyoto

Sponsors (1)

Lead Sponsor	Collaborator
Kyoto University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	The change in both SBP and DBP values between pre-exposure and post-exposure for each session (averaged over the regimen)		for each session	No
Secondary	The incidence of adverse events		during exposure and at the end of the exposure period and at six months after exposure	Yes