Mild to Moderate HypertensionNCT05530512
Acupuncture Therapy and Hypertension
A study testing electroacupuncture in people with Mild to Moderate Hypertension, run by University of California, Irvine at 2 sites in United States.
Trial summary
Acupuncture therapy will be provided to reduce blood pressure in hypertensive patients. The mild to moderate hypertensive patients will be either on or off hypertensive medications. The course last for 8 weeks and the frequency is once a week. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Mild to Moderate Hypertension
- What is being tested?
- electroacupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jan 2023to 31 Mar 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects from 45 to 75 years of age
- Clinically diagnosed with mild to moderate hypertension and ON or OFF medication (Office SBP > 140 mmHg and < 160 mmHg Or ABPM average SBP > 130 mmHg and < 145 mmHg), and
- No significant ECG change reflecting ischemia (i.e. ST elevation or depression) at rest will be recruited to participate in this study.
Who cannot join
- Subjects will be excluded if pregnant or nursing.
- Subjects will be excluded if they have coronary disease (by history or on ECG screening), 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 neuropathy or severe hypertension (BP >170 mmHg systolic or >110 mmHg diastolic), or any other physical or psychological illness.
- Those with known sensitivity to any topical preparations or strong reactions to medical dressings and skin tapes also will be excluded.
- Inability our or unwillingness of individual to give written informed consent.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Susan Samueli Integrative Health Institute
Irvine, California, 92697
Mitchell Beasley, MD, PhD, MPH, 949-824-7000, beasleym@uci.edu
Shaista Malik, PhD, 949-824-7000, smalik@hs.uci.edu
- Recruiting
University of California, Irvine, Health Sciences Medical Center
Orange, California, 92868
Herlinda Bergman, M.Sc., 714-456-7090
About this study
Official title: Neuroimmune Mechanisms Underlying Electroacupuncture Effect on Vascular Function
Acupuncture therapy will be provided to reduce blood pressure in hypertensive patients. The mild to moderate hypertensive patients will be either on or off hypertensive medications. The course last for 8 weeks and the frequency is once a week.
Read the detailed description
Improvement in BP control rates would lead to one of the largest impacts in improving life expectancy and the quality of life for over 100 million people in the United States and 1 billion people worldwide with immediate and measurable results. In the United States, 80% of patients with HTN are treated, but BP is controlled in only half of these individuals, with control worsening with increasing age. The reasons for inadequate treatment and BP control are complex, but one reason for this therapeutic misalignment may be an incomplete understanding of the mechanisms underlying the development and progression of HTN. The aging process leads to dysfunction of the ANS, resulting in neuroendocrine abnormalities and chronic low-grade inflammation.
The investigators have previously shown that electroacupuncture (EA) at four targeted acupoints, can decrease sympathetic activity [sympathoinhibitory (SI)], approaching levels close to those present prior to onset of HTN and may address this unmet need in HTN management. The investigators are now testing and have preliminary evidence that EA at two additional acupoints (SP6-7) increases parasympathetic activation, thereby decreasing circulating and tissue inflammatory biomarkers [thus anti-inflammatory (AI)] and when combined with SI-EA can improve measures of vascular health including endothelial function and arterial stiffness in preclinical model with overall greater reduction in BP. Together these combined six acupoints, when simultaneously activated by EA may restore optimal autonomic control of the immune system and target an important mechanistic pathway not addressed by BP-lowering pharmacotherapy alone. To date, 39 participants have been enrolled in the study.
- Conditions
- Mild to Moderate Hypertension
- Being tested
- electroacupuncture
- Keywords
- hypertension, electroacupuncture
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroacupunctureOther
Also called acupuncture
acupuncture needling and stimulation are applied for 30 min
| Study group | Role | What they receive |
|---|---|---|
| Anti-inflammatory EA (AI-EA) | Experimental | Anti-inflammatory electroacupuncture therapy Receives: Other: electroacupuncture |
| Sympathoinhibitory EA (SI-EA) | Experimental | sympatho-inhibitory electroacupuncture therapy Receives: Other: electroacupuncture |
| Combined EA (cEA) | Experimental | combination of SI-EA and AI-EA Receives: Other: electroacupuncture |
| Control EA (Sham-EA) | Experimental | Sham electroacupuncture Receives: Other: electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in sympathetic and parasympathetic nervous systems
Heart rate variability and its component will be evaluated with EKG.
Measured: through study completion, an average of 4.5 years
Secondary outcomes (1)
Change in biomarkers like cytokines
Plasma will be measured for inflammatory markers with ELISA kits.
Measured: through study completion, an average of 4.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start1 Jan 2023
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild to Moderate HypertensionStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- two by two factorial design for a 4 arm study.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Shaista Malik, University of California, Irvine
- Investigators
- Shaista Malik, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05530512
- Sponsor's protocol ID
- 19992222
- Other IDs
- R01AT011306
- Status last verified
- Jul 2025
- First submitted
- 27 Aug 2022
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimmune Mechanisms Underlying Electroacupuncture Effect on Vascular Function
- ClinicalTrials.gov ID
- NCT05530512
- Acronym / sponsor ID
- 19992222
- Conditions
- Mild to Moderate Hypertension
- Keywords
- hypertension, electroacupuncture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 7 Sep 2022 (actual)
- 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.
Acupuncture therapy will be provided to reduce blood pressure in hypertensive patients. The mild to moderate hypertensive patients will be either on or off hypertensive medications. The course last for 8 weeks and the frequency is once a week.
Detailed description
Improvement in BP control rates would lead to one of the largest impacts in improving life expectancy and the quality of life for over 100 million people in the United States and 1 billion people worldwide with immediate and measurable results. In the United States, 80% of patients with HTN are treated, but BP is controlled in only half of these individuals, with control worsening with increasing age. The reasons for inadequate treatment and BP control are complex, but one reason for this therapeutic misalignment may be an incomplete understanding of the mechanisms underlying the development and progression of HTN. The aging process leads to dysfunction of the ANS, resulting in neuroendocrine abnormalities and chronic low-grade inflammation.
The investigators have previously shown that electroacupuncture (EA) at four targeted acupoints, can decrease sympathetic activity [sympathoinhibitory (SI)], approaching levels close to those present prior to onset of HTN and may address this unmet need in HTN management. The investigators are now testing and have preliminary evidence that EA at two additional acupoints (SP6-7) increases parasympathetic activation, thereby decreasing circulating and tissue inflammatory biomarkers [thus anti-inflammatory (AI)] and when combined with SI-EA can improve measures of vascular health including endothelial function and arterial stiffness in preclinical model with overall greater reduction in BP. Together these combined six acupoints, when simultaneously activated by EA may restore optimal autonomic control of the immune system and target an important mechanistic pathway not addressed by BP-lowering pharmacotherapy alone. To date, 39 participants have been enrolled in the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- two by two factorial design for a 4 arm study.
| Arm | Type | Receives |
|---|---|---|
| Anti-inflammatory EA (AI-EA) | Experimental | Other: electroacupunctureAnti-inflammatory electroacupuncture therapy |
| Sympathoinhibitory EA (SI-EA) | Experimental | Other: electroacupuncturesympatho-inhibitory electroacupuncture therapy |
| Combined EA (cEA) | Experimental | Other: electroacupuncturecombination of SI-EA and AI-EA |
| Control EA (Sham-EA) | Experimental | Other: electroacupunctureSham electroacupuncture |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects from 45 to 75 years of age
- Clinically diagnosed with mild to moderate hypertension and ON or OFF medication (Office SBP > 140 mmHg and < 160 mmHg Or ABPM average SBP > 130 mmHg and < 145 mmHg), and
- No significant ECG change reflecting ischemia (i.e. ST elevation or depression) at rest will be recruited to participate in this study.
Key exclusion criteria (4 listed)
- Subjects will be excluded if pregnant or nursing.
- Subjects will be excluded if they have coronary disease (by history or on ECG screening), 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 neuropathy or severe hypertension (BP >170 mmHg systolic or >110 mmHg diastolic), or any other physical or psychological illness.
- Those with known sensitivity to any topical preparations or strong reactions to medical dressings and skin tapes also will be excluded.
- Inability our or unwillingness of individual to give written informed consent.
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 |
|---|---|---|
| electroacupunctureAlso: acupunctureacupuncture needling and stimulation are applied for 30 min | Other | Anti-inflammatory EA (AI-EA), Combined EA (cEA), Control EA (Sham-EA), Sympathoinhibitory EA (SI-EA) |
Primary outcome
Changes in sympathetic and parasympathetic nervous systems
Time frame: through study completion, an average of 4.5 years
Heart rate variability and its component will be evaluated with EKG.
1 secondary outcome
Change in biomarkers like cytokines
Time frame: through study completion, an average of 4.5 years
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 20 Jul 2025.
- animal studyLink provided by the sponsor.
- 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 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 electroacupuncture in people with Mild to Moderate 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 3 inclusion and 4 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 20 Jul 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 Ashwini Erande (7144567025, aerande@hs.uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in sympathetic and parasympathetic nervous systems (time frame: through study completion, an average of 4.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2025.