Acupuncture Therapy and Hypertension

NCT ID: NCT05530512

Last Updated: 2025-07-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2027-03-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Anti-inflammatory EA (AI-EA)

Anti-inflammatory electroacupuncture therapy

Group Type: EXPERIMENTAL

electroacupuncture

Intervention Type: OTHER

acupuncture needling and stimulation are applied for 30 min

Sympathoinhibitory EA (SI-EA)

sympatho-inhibitory electroacupuncture therapy

Group Type: EXPERIMENTAL

electroacupuncture

Intervention Type: OTHER

acupuncture needling and stimulation are applied for 30 min

Combined EA (cEA)

combination of SI-EA and AI-EA

Group Type: EXPERIMENTAL

electroacupuncture

Intervention Type: OTHER

acupuncture needling and stimulation are applied for 30 min

Control EA (Sham-EA)

Sham electroacupuncture

Group Type: EXPERIMENTAL

electroacupuncture

Intervention Type: OTHER

acupuncture needling and stimulation are applied for 30 min

Interventions

electroacupuncture

acupuncture needling and stimulation are applied for 30 min

Intervention Type: OTHER

Other Intervention Names

acupuncture

Eligibility Criteria

Inclusion Criteria

1. Subjects from 45 to 75 years of age

2. 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

3. No significant ECG change reflecting ischemia (i.e. ST elevation or depression) at rest will be recruited to participate in this study.

Exclusion Criteria

1. Subjects will be excluded if pregnant or nursing.

2. 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.

3. Those with known sensitivity to any topical preparations or strong reactions to medical dressings and skin tapes also will be excluded.

4. Inability our or unwillingness of individual to give written informed consent.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Shaista Malik

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shaista Malik

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

Susan Samueli Integrative Health Institute

Irvine, California, United States

Site Status: RECRUITING

University of California, Irvine, Health Sciences Medical Center

Orange, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ashwini Erande

Role: CONTACT

aerande@hs.uci.edu

7144567025

Facility Contacts

Mitchell Beasley, MD, PhD, MPH

Role: primary

beasleym@uci.edu

949-824-7000

Shaista Malik, PhD

Role: backup

smalik@hs.uci.edu

949-824-7000

Herlinda Bergman, M.Sc.

Role: primary

714-456-7090

Related Links

https://doi.org/10.1089/acu.2015.1106

clinical study

https://doi.org/10.3389/fcvm.2023.1140255

animal study

Other Identifiers

R01AT011306

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19992222

Identifier Type: -

Identifier Source: org_study_id