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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2009 by Kyunghee University Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01002846
First Posted: October 27, 2009
Last Update Posted: October 27, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Kyunghee University Medical Center
  Purpose
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.

Condition Intervention Phase
Hypertension Procedure: acupuncture Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effects of Acupuncture at ST36 and PC6 on Blood Pressure and Endothelial

Resource links provided by NLM:


Further study details as provided by Kyunghee University Medical Center:

Primary Outcome Measures:
  • To assess effects of acupuncture on endothelial function with FMD variation after 8 weeks treatments. [ Time Frame: 8 weeks ]

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

Estimated Enrollment: 32
Study Start Date: September 2009
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01002846


Contacts
Contact: Hyemi Kim, OMD +82/2/440/8558 muskan0907@gmail.com
Contact: SeounUk Park, OMD +82/2/440/7151 happyomd@dreamwiz.com

Locations
Korea, Republic of
Oriental Medicine of Stroke and Nerologic center Recruiting
Seoul, South Korea, Korea, Republic of
Sponsors and Collaborators
Kyunghee University Medical Center
Investigators
Principal Investigator: SeongUk Park, OMD Oriental medicine center of Stroke and Neurology
  More Information

Responsible Party: Oriental Medicine of Stroke & Neurological Disorders Center
ClinicalTrials.gov Identifier: NCT01002846     History of Changes
Other Study ID Numbers: KHNMC/5H/IRB/2009/007
First Submitted: October 26, 2009
First Posted: October 27, 2009
Last Update Posted: October 27, 2009
Last Verified: October 2009

Keywords provided by Kyunghee University Medical Center:
Efficacy
Acupuncture
Hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases