NCT00932139

Brief Summary

Based on previous published research in animals and human, the investigators hypothesize that electroacupuncture (EA) will have a positive effect on hypertension.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
18mo left

Started Feb 2003

Longer than P75 for not_applicable hypertension

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 Progress94%
Feb 2003Dec 2027

Study Start

First participant enrolled

February 1, 2003

Completed
6.4 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2009

Completed
18.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

April 15, 2025

Status Verified

April 1, 2025

Enrollment Period

24.6 years

First QC Date

July 1, 2009

Last Update Submit

April 10, 2025

Conditions

Hypertension

Keywords

Hypertensionblood pressuremild to moderate hypertension

Outcome Measures

Primary Outcomes (1)

  • blood pressure

    evaluation of systolic and diastolic blood pressures changes

    8 weeks

Secondary Outcomes (3)

  • Heart rate

    8 weeks

  • plasma catecholamine

    8 weeks

  • plasma renin

    8 weeks

Study Arms (2)

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.

Procedure: Electro-acupuncture controlProcedure: 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.

Procedure: Electro-acupuncture controlProcedure: Electro-acupuncture test

Interventions

Electro-acupuncture controlPROCEDURE

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.

Also known as: Blood pressure, Hypertension
Electro-acupuncture controlElectro-acupuncture test
Electro-acupuncture testPROCEDURE

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.

Also known as: Blood pressure, Hypertension
Electro-acupuncture controlElectro-acupuncture test

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with mild coronary disease, and no significant ECG change reflecting ischemia at rest.
  • Patients with high blood pressure with or without antihypertensive medication.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Susan Samueli Integrative Health Institute

Irvine, California, 92617, United States

RECRUITING

UCIMedical Center

Orange, California, 92868, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 26392838BACKGROUND

MeSH Terms

Conditions

Hypertension

Interventions

Blood Pressure

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Vital SignsPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisHemodynamicsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Shaista Malik, MD, PhD, MPH

    University of California, Irvine

    PRINCIPAL INVESTIGATOR

  • Liang-Wu Fu, MD, PhD

    University of California, Irvine

    PRINCIPAL INVESTIGATOR

  • LiFang Xie, PhD, LAc

    University of California, Irvine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Tjen-A-Looi, PhD

CONTACT

9494005909stjenalo@uci.edu

Shaista Malik, MD, PhD, MPH

CONTACT

smalik@uci.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two different formulated sets of acupoints will be used as EA intervention in the treatment of hypertension.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 1, 2009

First Posted

July 3, 2009

Study Start

February 1, 2003

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

April 15, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

US(2)