NCT00724763

Brief Summary

This research is designed to study the effects of needle acupuncture on blood pressure and HRV by stimulating certain acupuncture points and meridians.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_1 hypertension

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 30, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Last Updated

July 30, 2008

Status Verified

July 1, 2008

Enrollment Period

1 year

First QC Date

July 28, 2008

Last Update Submit

July 29, 2008

Conditions

Hypertension

Keywords

acupuncture, high blood pressure, HRV

Outcome Measures

Primary Outcomes (1)

  • Blood pressure and HRV

    five weeks

Study Arms (2)

1

EXPERIMENTAL

Treatment group.

Device: acupuncture

2

SHAM COMPARATOR

control group

Device: sham needle treatment

Interventions

acupunctureDEVICE

to Liv 3 and PE 9.

1
sham needle treatmentDEVICE

needle not in meridian area

2

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female suffering from mild hypertension (systolic BP between 130-165 mmHg, diastolic BP between 90-120 mmHg).

You may not qualify if:

  • Individuals with heart, kidney, thyroid disorders, diabetes, chronic disease or illness, neurological diseases, skin or bleeding disorders,
  • Currently taking prescription or OTC medications and/or herb/supplements that effect BP or autonomic tone will not be recruited into the study.
  • In addition, individuals who have a pacemaker and/or are pregnant will not be recruited in the study. A health history questionnaire was used to screen subjects.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Logan University

Chesterfield, Missouri, 63017, United States

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 28, 2008

First Posted

July 30, 2008

Study Start

July 1, 2008

Primary Completion

July 1, 2009

Last Updated

July 30, 2008

Record last verified: 2008-07

Locations

US(1)