Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

October 26, 2009
October 26, 2009
September 2009
June 2010   (final data collection date for primary outcome measure)
To assess effects of acupuncture on endothelial function with FMD variation after 8 weeks treatments. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
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 ]
Same as current
Not Provided
Not Provided
 
Effects of Acupuncture at ST36 and PC6 on Blood Pressure and Endothelial Dysfunction in Hypertensive Patients
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Hypertension
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.
  • 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
    Intervention: Procedure: acupuncture
  • 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.
    Intervention: Procedure: acupuncture
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
32
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
Yes
Contact: Hyemi Kim, OMD +82/2/440/8558 muskan0907@gmail.com
Contact: SeounUk Park, OMD +82/2/440/7151 happyomd@dreamwiz.com
Korea, Republic of
 
NCT01002846
KHNMC/5H/IRB/2009/007
Yes
Oriental Medicine of Stroke & Neurological Disorders Center
Kyunghee University Medical Center
Not Provided
Principal Investigator: SeongUk Park, OMD Oriental medicine center of Stroke and Neurology
Kyunghee University Medical Center
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP