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Effects of Acupuncture at ST36 and PC6 on Blood Pressure and Endothelial Dysfunction in Hypertensive Patients

Primary Purpose

Hypertension

Status

Unknown status

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

acupuncture

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Efficacy, Acupuncture, Hypertension

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Patients age 18-70 diagnosed stage I hypertension ( JNC-7) without taking hypertensive medication

Exclusion Criteria:

Secondary hypertension
DM
History of cardiovascular disease
Taking hypertensive medication
Taking hyperlipidemic medication
Smoking
Pregnancy or feeding woman
Cannot follow indication or there is no agreement of patient and conservator
Investigator decide Inappropriate to trial

Sites / Locations

Oriental Medicine of Stroke and Nerologic centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

traditional acupuncture

sham acupuncture

Arm Description

Procedure : ST 36 and PC 6 are selected, subject will undergo 20minute sessions twice a week for 8weeks. Disposable acupuncture needle(4cm sterilized stainless steel) will be inserted up to 1 cm depth

Procedure : Beside 1cm of ST 36 and PC 6 are selected( not meridian point), subject will undergo 20 minute. Disposable acupuncture needle(4cm sterilized stainless steel) will be inserted under 1 cm slightly.

Outcomes

Primary Outcome Measures

To assess effects of acupuncture on endothelial function with FMD variation after 8 weeks treatments.

Secondary Outcome Measures

To examine the effects of acupuncture on blood pressure, lipid , hsCRP level variation with ABPM after 8 weeks treatments.

Full Information

NCT ID

NCT01002846

First Posted

October 26, 2009

Last Updated

October 26, 2009

Sponsor

Kyunghee University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01002846

Brief Title

Effects of Acupuncture at ST36 and PC6 on Blood Pressure and Endothelial Dysfunction in Hypertensive Patients

Official Title

Effects of Acupuncture at ST36 and PC6 on Blood Pressure and Endothelial

Study Type

Interventional

2. Study Status

Record Verification Date

October 2009

Overall Recruitment Status

Unknown status

Study Start Date

September 2009 (undefined)

Primary Completion Date

June 2010 (Anticipated)

Study Completion Date

June 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Kyunghee University Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is randomised, controlled study about effects of acupuncture on blood pressure and endothelial dysfunction in stage I hypertension patient without medication. Subject will receive 8 weeks of either acupuncture or sham acupuncture, measuring FMD and blood test before and after treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension

Keywords

Efficacy, Acupuncture, Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

traditional acupuncture

Arm Type

Experimental

Arm Description

Arm Title

sham acupuncture

Arm Type

Sham Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

acupuncture

Intervention Description

acupuncture group : subject will undergo 20minute sessions twice a week for 8weeks. Disposable acupuncture needle(4cm sterilized stainless steel) will be inserted up to 1 cm depth sham acupuncture group : subject will undergo 20 minute. Disposable acupuncture needle(4cm sterilized stainless steel) will be inserted under 1 cm slightly.

Primary Outcome Measure Information:

Title

To assess effects of acupuncture on endothelial function with FMD variation after 8 weeks treatments.

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

To examine the effects of acupuncture on blood pressure, lipid , hsCRP level variation with ABPM after 8 weeks treatments.

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients age 18-70 diagnosed stage I hypertension ( JNC-7) without taking hypertensive medication Exclusion Criteria: Secondary hypertension DM History of cardiovascular disease Taking hypertensive medication Taking hyperlipidemic medication Smoking Pregnancy or feeding woman Cannot follow indication or there is no agreement of patient and conservator Investigator decide Inappropriate to trial

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hyemi Kim, OMD

Phone

+82/2/440/8558

muskan0907@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

SeounUk Park, OMD

Phone

+82/2/440/7151

happyomd@dreamwiz.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

SeongUk Park, OMD

Organizational Affiliation

Oriental medicine center of Stroke and Neurology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Oriental Medicine of Stroke and Nerologic center

City

Seoul

State/Province

South Korea

Country

Korea, Republic of

Individual Site Status

Recruiting

12. IPD Sharing Statement

Learn more about this trial

Effects of Acupuncture at ST36 and PC6 on Blood Pressure and Endothelial Dysfunction in Hypertensive Patients

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