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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Kyunghee University Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Kyunghee University Medical Center
ClinicalTrials.gov Identifier:
NCT01002846
First received: October 26, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: October 26, 2009
Last Updated: October 26, 2009
Health Authority: Korea: Ministry for Health, Welfare and Family Affairs

Keywords provided by Kyunghee University Medical Center:
Efficacy
Acupuncture
Hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014