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The Effect of Acupuncture on Blood Pressure and Heart Rate Variability (HRV) (Acupuncture)

Primary Purpose

Hypertension

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
acupuncture
sham needle treatment
Sponsored by
Logan College of Chiropractic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring acupuncture, high blood pressure, HRV

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Logan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

1

2

Arm Description

Treatment group.

control group

Outcomes

Primary Outcome Measures

Blood pressure and HRV

Secondary Outcome Measures

Full Information

First Posted
July 28, 2008
Last Updated
July 29, 2008
Sponsor
Logan College of Chiropractic
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1. Study Identification

Unique Protocol Identification Number
NCT00724763
Brief Title
The Effect of Acupuncture on Blood Pressure and Heart Rate Variability (HRV)
Acronym
Acupuncture
Official Title
The Effect of Acupuncture on Blood Pressure and HRV
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Unknown status
Study Start Date
July 2008 (undefined)
Primary Completion Date
July 2009 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Logan College of Chiropractic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Outcome measurements include blood pressure and heart rate variability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
acupuncture, high blood pressure, HRV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Treatment group.
Arm Title
2
Arm Type
Sham Comparator
Arm Description
control group
Intervention Type
Device
Intervention Name(s)
acupuncture
Intervention Description
to Liv 3 and PE 9.
Intervention Type
Device
Intervention Name(s)
sham needle treatment
Intervention Description
needle not in meridian area
Primary Outcome Measure Information:
Title
Blood pressure and HRV
Time Frame
five weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male or female suffering from mild hypertension (systolic BP between 130-165 mmHg, diastolic BP between 90-120 mmHg). Exclusion Criteria: 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.
Facility Information:
Facility Name
Logan University
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Zhang, MD, PhD
Phone
636-230-1920
Email
john.zhang@logan.edu
First Name & Middle Initial & Last Name & Degree
John Zhang, MD, PhD

12. IPD Sharing Statement

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The Effect of Acupuncture on Blood Pressure and Heart Rate Variability (HRV)

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