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This study will evaluate the efficacy and safety of weak extremely low frequency electromagnetic fields (ELF-EMF) in mild and moderate essential hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1,Exposed to ELF-EMF | Active Comparator | Device: Magnetic field generator Exposure to 1-μT 8/6-Hz ELF-EMF |
|
| 2,Placebo | Placebo Comparator | Device: Placebo device with no magnetic fields |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic field generator | Device | dosage:Magnetic field generator Exposure to 1-μT 8/6-Hz ELF-EMF frequency:10min/day duration:1 month |
|
| Measure | Description | 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). | baseline and the end of the exposure regimen (the average of the pre-exposure values for the last two sessions) |
| Measure | Description | 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) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Masanori Fukushima | Kyoto University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyoto University Hospital | Kyoto | Kyoto | 606-8507 | Japan |
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| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Placebo magnetic field generator | Device | Placebo device with no magnetic fields |
|
| for each session |
| The incidence of adverse events | during exposure and at the end of the exposure period and at six months after exposure |