HypertensionNCT00932139
Effect of Electro-Acupuncture on Blood Pressure
A study testing Electro-acupuncture test in people with Hypertension, run by University of California, Irvine at 2 sites in United States.
Trial summary
Based on previous published research in animals and human, the investigators hypothesize that electroacupuncture (EA) will have a positive effect on hypertension. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Electro-acupuncture test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2003to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with mild coronary disease, and no significant ECG change reflecting ischemia at rest.
- Patients with high blood pressure with or without antihypertensive medication.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Shaista Malik, MD, PhD, MPH contact
United States2 sites, 2 recruiting
- Recruiting
Susan Samueli Integrative Health Institute
Irvine, California, 92617
Mitchell Beasley, MD, PhD, MPH, 949-824-7000, beasleym@uci.edu
Shaista Malik, PhD, 949-824-7000, smalik@hs.uci.edu
- Recruiting
UCIMedical Center
Orange, California, 92868
Shaista Malik, MD, PhD, MPH, smalik@uci.edu
About this study
Official title: Neural Mechanism of the Effect of Acupuncture on Hypertension
Based on previous published research in animals and human, the investigators hypothesize that electroacupuncture (EA) will have a positive effect on hypertension.
Read the detailed description
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.
- Conditions
- Hypertension
- Being tested
- Electro-acupuncture control, Electro-acupuncture test
- Keywords
- Hypertension, blood pressure, mild to moderate hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electro-acupuncture controlProcedure or surgery
Also called Blood pressure, Hypertension
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.
Electro-acupuncture testProcedure or surgery
Also called Blood pressure, Hypertension
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. At end of 8-week treatment, 24 hours blood pressure and heart rate will be measured.
| Study group | Role | What they receive |
|---|---|---|
| Electro-acupuncture control | Experimental | 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. Receives: Procedure: Electro-acupuncture control; Procedure: Electro-acupuncture test |
| Electro-acupuncture test | Experimental | 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. Receives: Procedure: Electro-acupuncture control; Procedure: Electro-acupuncture test |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure
evaluation of systolic and diastolic blood pressures changes
Measured: 8 weeks
Secondary outcomes (3)
Heart rate
evaluation of heart rate change
Measured: 8 weeks
plasma catecholamine
evaluation of plasma catecholamine (ng/ml) change
Measured: 8 weeks
plasma renin
evaluation of plasma renin (ng/ml.hr) change
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2009 (estimated)
- Study startFeb 2003
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two different formulated sets of acupoints will be used as EA intervention in the treatment of hypertension.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaista Malik, University of California, Irvine
- Investigators
- Shaista Malik, MD, PhD, MPH, Principal investigator, University of California, IrvineLiang-Wu Fu, MD, PhD, Principal investigator, University of California, IrvineLiFang Xie, PhD, LAc, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00932139
- Sponsor's protocol ID
- 1999-2222
- Status last verified
- Apr 2025
- First submitted
- 1 Jul 2009
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li P, Tjen-A-Looi SC, Cheng L, Liu D, Painovich J, Vinjamury S, Longhurst JC. Long-Lasting Reduction of Blood Pressure by Electroacupuncture in Patients with Hypertension: Randomized Controlled Trial. Med Acupunct. 2015 Aug 1;27(4):253-266. doi: 10.1089/acu.2015.1106.
PubMed 26392838
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Mechanism of the Effect of Acupuncture on Hypertension
- ClinicalTrials.gov ID
- NCT00932139
- Acronym / sponsor ID
- 1999-2222
- Conditions
- Hypertension
- Keywords
- Hypertension, blood pressure, mild to moderate hypertension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- Feb 2003
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 3 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Based on previous published research in animals and human, the investigators hypothesize that electroacupuncture (EA) will have a positive effect on hypertension.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two different formulated sets of acupoints will be used as EA intervention in the treatment of hypertension.
| Arm | Type | Receives |
|---|---|---|
| Electro-acupuncture control | Experimental | Procedure: Electro-acupuncture control, Procedure: Electro-acupuncture testBlood 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. |
| Electro-acupuncture test | Experimental | Procedure: Electro-acupuncture control, Procedure: Electro-acupuncture testBlood 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with mild coronary disease, and no significant ECG change reflecting ischemia at rest.
- Patients with high blood pressure with or without antihypertensive medication.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electro-acupuncture controlAlso: Blood pressure, HypertensionFirst 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. | Procedure or surgery | Electro-acupuncture control, Electro-acupuncture test |
| Electro-acupuncture testAlso: Blood pressure, HypertensionFirst 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. At end of 8-week treatment, 24 hours blood pressure and heart rate will be measured. | Procedure or surgery | Electro-acupuncture control, Electro-acupuncture test |
Primary outcome
blood pressure
Time frame: 8 weeks
evaluation of systolic and diastolic blood pressures changes
3 secondary outcomes
Heart rate
Time frame: 8 weeks
plasma catecholamine
Time frame: 8 weeks
plasma renin
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Background: PubMed 26392838Li P, Tjen-A-Looi SC, Cheng L, Liu D, Painovich J, Vinjamury S, Longhurst JC. Long-Lasting Reduction of Blood Pressure by Electroacupuncture in Patients with Hypertension: Randomized Controlled Trial. Med Acupunct. 2015 Aug 1;27(4):253-266. doi: 10.1089/acu.2015.1106.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shaista Malik, MD, PhD, MPH contact
Shaista Malik, MD, PhD, MPH principal investigator
University of California, Irvine
Liang-Wu Fu, MD, PhD principal investigator
University of California, Irvine
LiFang Xie, PhD, LAc principal investigator
University of California, Irvine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electro-acupuncture test in people with Hypertension, run by University of California, Irvine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Tjen-A-Looi, PhD (9494005909, stjenalo@uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood pressure (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00932139, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.