Effects of Acupuncture at ST36 and PC6 on Blood Pressure and Endothelial Dysfunction in Hypertensive Patients
1 other identifier
interventional
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 hypertension
Started Sep 2009
Shorter than P25 for phase_3 hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 26, 2009
CompletedFirst Posted
Study publicly available on registry
October 27, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedOctober 27, 2009
October 1, 2009
9 months
October 26, 2009
October 26, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess effects of acupuncture on endothelial function with FMD variation after 8 weeks treatments.
8 weeks
Secondary Outcomes (1)
To examine the effects of acupuncture on blood pressure, lipid , hsCRP level variation with ABPM after 8 weeks treatments.
8 weeks
Study Arms (2)
traditional acupuncture
EXPERIMENTALProcedure : 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
sham acupuncture
SHAM COMPARATORProcedure : 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.
Interventions
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 Criteria
You may qualify if:
- Patients age 18-70 diagnosed stage I hypertension ( JNC-7) without taking hypertensive medication
You may not qualify if:
- Secondary hypertension
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oriental Medicine of Stroke and Nerologic center
Seoul, South Korea, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
SeongUk Park, OMD
Oriental medicine center of Stroke and Neurology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 26, 2009
First Posted
October 27, 2009
Study Start
September 1, 2009
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
October 27, 2009
Record last verified: 2009-10