Effect of Electro-Acupuncture on Blood Pressure
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ClinicalTrials.gov Identifier: NCT00932139 |
Recruitment Status :
Recruiting
First Posted : July 3, 2009
Last Update Posted : April 2, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypertension | Procedure: Electro-acupuncture control Procedure: Electro-acupuncture test | Not Applicable |
The purpose of this study is to prove: (1) hypertensive response at rest and provoked by stress are decreased by EA; (2) The mechanisms of EA that reduces elevated blood pressure. EA inhibits the sympathetic nervous system, decreases blood pressure and reduces the oxygen demand. Our prior data in animals shows that improvements in cardiovascular function during myocardial ischemia, reflex hypertension and sustained hypertension are mediated by an EA-induced sensory neural reflex originating in somatic nerves to reduce sympathetic nerve activity. The specific aims of the present study will allow us to better understand and modulate the sympathetic nervous discharge activity that can cause hypertension during normal activity and stress in humans. The potential clinical application is the therapeutic value of EA in patients with hypertension.
Furthermore, the study will also investigate gender differences in the blood pressure lowering effect of EA. In particular in middle-aged hypertensive women and men.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 160 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Two different formulated sets of acupoints will be used as EA intervention in the treatment of hypertension. |
Masking: | Triple (Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | The care provider or acupuncturist does not know the outcome of the treatment. The investigator does not know the participants and the outcome of the study. The outcome assessor does not know the participants. |
Primary Purpose: | Treatment |
Official Title: | Neural Mechanism of the Effect of Acupuncture on Hypertension |
Study Start Date : | February 2003 |
Estimated Primary Completion Date : | September 2025 |
Estimated Study Completion Date : | December 2025 |

Arm | Intervention/treatment |
---|---|
Experimental: Electro-acupuncture control
Blood pressure will be recorded before and after each EA treatment for 8 weeks. The course is a once a week 8-week treatment. Intervention is the Electro-acupuncture control treatment. |
Procedure: Electro-acupuncture control
First visit, blood pressure monitoring for 60 minutes at rest, then monitoring for subsequent 24 hours to measure BP and heart rate. At next 6-8 visits, Electro-acupuncture (EA) treatment for 30 minutes will be administered. BP and heart rate measurements will be taken 30 minutes before and after EA.
Other Names:
Procedure: Electro-acupuncture test First visit, blood pressure monitoring for 60 minutes at rest, then monitoring for subsequent 24 hours to measure BP and heart rate. At next 6-8 visits, Electro-acupuncture (EA) treatment for 30 minutes will be administered. BP and heart rate measurements will be taken 30 minutes before and after EA.
Other Names:
|
Experimental: Electro-acupuncture test
Blood pressure will be recorded before and after each EA treatment for 8 weeks. The course is a once a week 8-week treatment. Intervention is the active Electro-acupuncture treatment. |
Procedure: Electro-acupuncture control
First visit, blood pressure monitoring for 60 minutes at rest, then monitoring for subsequent 24 hours to measure BP and heart rate. At next 6-8 visits, Electro-acupuncture (EA) treatment for 30 minutes will be administered. BP and heart rate measurements will be taken 30 minutes before and after EA.
Other Names:
Procedure: Electro-acupuncture test First visit, blood pressure monitoring for 60 minutes at rest, then monitoring for subsequent 24 hours to measure BP and heart rate. At next 6-8 visits, Electro-acupuncture (EA) treatment for 30 minutes will be administered. BP and heart rate measurements will be taken 30 minutes before and after EA.
Other Names:
|
- blood pressure [ Time Frame: 8 weeks ]evaluation of systolic and diastolic blood pressures changes
- Heart rate [ Time Frame: 8 weeks ]evaluation of heart rate change
- plasma catecholamine [ Time Frame: 8 weeks ]evaluation of plasma catecholamine (ng/ml) change
- plasma renin [ Time Frame: 8 weeks ]evaluation of plasma renin (ng/ml.hr) change

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Ages Eligible for Study: | 39 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with mild coronary disease, and no significant ECG change reflecting ischemia at rest.
- Patients with high blood pressure with or without antihypertensive medication.
Exclusion Criteria:
- Pregnant or nursing women
- Individuals with severe coronary disease (continuous angina)
- Conduction abnormalities on ECG consistent with left bundle branch block
- Cardiac arrhythmias associated with low blood pressure (90 mmHg)
- Peripheral vascular disease
- Orthopedic disease
- Diabetic or psychological illness that could interfere with safe performance of exercise of psychophysiological stress testing
- Those with known sensitivity to topical preparations or strong reactions to medical dressings and skin tapes

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): NCT00932139
Contact: Stephanie Tjen-A-Looi, PhD | stjenalo@uci.edu | ||
Contact: Shaista Malik, MD, PhD, MPH | smalik@uci.edu |
United States, California | |
Susan Samueli Integrative Health Institute | Recruiting |
Costa Mesa, California, United States, 92626 | |
Contact: Shaista Malik, MD, PhD, MPH smalik@uci.edu | |
Contact: Stephanie Tjen-A-Looi, PhD stjenalo@uci.edu | |
Principal Investigator: Stephanie Tjen-A-Looi, PhD | |
Sub-Investigator: LiFang Xie, PhD, LAc | |
Principal Investigator: Shaista Malik, MD, PhD, MPH | |
UCIMedical Center | Recruiting |
Orange, California, United States, 92868 | |
Contact: Shaista Malik, MD, PhD, MPH smalik@uci.edu |
Principal Investigator: | Stephanie Tjen-A-Looi, PhD | University of California, Irvine | |
Principal Investigator: | Liang-Wu Fu, MD, PhD | University of California, Irvine | |
Principal Investigator: | Shaista Malik, MD, PhD, MPH | University of California, Irvine | |
Principal Investigator: | LiFang Xie, PhD, LAc | University of California, Irvine |
Responsible Party: | Shaista Malik, Professor, University of California, Irvine |
ClinicalTrials.gov Identifier: | NCT00932139 |
Other Study ID Numbers: |
1999-2222 |
First Posted: | July 3, 2009 Key Record Dates |
Last Update Posted: | April 2, 2021 |
Last Verified: | March 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Hypertension blood pressure mild to moderate hypertension |
Hypertension Vascular Diseases Cardiovascular Diseases |