NCT00709930CompletedPhase 2
Randomized Placebo-Controlled Trial of Efficacy and Safety of Weak Extremely Low Frequency Electromagnetic Field in Mild and Moderate Essential Hypertension
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Kyoto University
- Enrollment
- 20
- Locations
- 2
- 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).
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 74 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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)
Investigators
Study Sites (2)
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