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

October 26, 2009 updated by: Kyunghee University Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • South Korea
      • Seoul, South Korea, Korea, Republic of
        • Recruiting
        • Oriental Medicine of Stroke and Nerologic center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: traditional acupuncture
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: acupuncture
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.
Sham Comparator: sham acupuncture
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.
Procedure: acupuncture
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess effects of acupuncture on endothelial function with FMD variation after 8 weeks treatments.
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyunghee University Medical Center

Investigators

  • Principal Investigator: SeongUk Park, OMD, Oriental medicine center of Stroke and Neurology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Anticipated)

June 1, 2010

Study Completion (Anticipated)

June 1, 2010

Study Registration Dates

First Submitted

October 26, 2009

First Submitted That Met QC Criteria

October 26, 2009

First Posted (Estimate)

October 27, 2009

Study Record Updates

Last Update Posted (Estimate)

October 27, 2009

Last Update Submitted That Met QC Criteria

October 26, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KHNMC/5H/IRB/2009/007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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