NCT05530512

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
11mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Jan 2023Mar 2027

First Submitted

Initial submission to the registry

August 27, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 7, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Expected
Last Updated

July 20, 2025

Status Verified

July 1, 2025

Enrollment Period

3.2 years

First QC Date

August 27, 2022

Last Update Submit

July 16, 2025

Conditions

Mild to Moderate Hypertension

Keywords

hypertension, electroacupuncture

Outcome Measures

Primary Outcomes (1)

  • Changes in sympathetic and parasympathetic nervous systems

    Heart rate variability and its component will be evaluated with EKG.

    through study completion, an average of 4.5 years

Secondary Outcomes (1)

  • Change in biomarkers like cytokines

    through study completion, an average of 4.5 years

Other Outcomes (1)

  • Change in blood pressure

    through study completion, an average of 4.5 years

Study Arms (4)

Anti-inflammatory EA (AI-EA)

EXPERIMENTAL

Anti-inflammatory electroacupuncture therapy

Other: electroacupuncture

Sympathoinhibitory EA (SI-EA)

EXPERIMENTAL

sympatho-inhibitory electroacupuncture therapy

Other: electroacupuncture

Combined EA (cEA)

EXPERIMENTAL

combination of SI-EA and AI-EA

Other: electroacupuncture

Control EA (Sham-EA)

EXPERIMENTAL

Sham electroacupuncture

Other: electroacupuncture

Interventions

electroacupunctureOTHER

acupuncture needling and stimulation are applied for 30 min

Also known as: acupuncture
Anti-inflammatory EA (AI-EA)Combined EA (cEA)Control EA (Sham-EA)Sympathoinhibitory EA (SI-EA)

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Susan Samueli Integrative Health Institute

Irvine, California, 92697, United States

RECRUITING

University of California, Irvine, Health Sciences Medical Center

Orange, California, 92868, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Hypertension

Interventions

ElectroacupunctureAcupuncture Therapy

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsComplementary TherapiesElectric Stimulation TherapyPhysical Therapy ModalitiesRehabilitationTranscutaneous Electric Nerve StimulationAnalgesiaAnesthesia and AnalgesiaAnesthesia

Study Officials

  • Shaista Malik

    University of California, Irvine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashwini Erande

CONTACT

7144567025aerande@hs.uci.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The pharmacologist who assays the plasma and serum is masked in the study.
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Model Details: two by two factorial design for a 4 arm study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 27, 2022

First Posted

September 7, 2022

Study Start

January 1, 2023

Primary Completion

March 31, 2026

Study Completion (Estimated)

March 31, 2027

Last Updated

July 20, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(2)