The Effect of Acupuncture on Blood Pressure and Heart Rat... | NCT00724763

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

NCT00724763

Sponsor

Logan College of Chiropractic

Status

Unknown status

Last Update Posted

Jul 30, 2008Estimated

Enrollment

40Estimated

Phase

Phase 1Phase 2

Conditions

Hypertension

Interventions

acupuncture
sham needle treatment

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Jul 2009Estimated

Completion Date

Not provided

First Submitted Date

Jul 28, 2008

First Submission Date that Met QC Criteria

Jul 29, 2008

First Posted Date

Jul 30, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2008

Last Update Posted Date

Jul 30, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Treatment group.	Device: acupuncture
2	Sham Comparator	control group	Device: sham needle treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
acupuncture	Device	to Liv 3 and PE 9.	1
sham needle treatment

Measure	Description	Time Frame
Blood pressure and HRV		five weeks

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Logan University	Recruiting	Chesterfield	Missouri	63017	United States

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015670	Acupuncture Therapy

Ancestor Terms

ID	Term
D000529	Complementary Therapies
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided