NCT04514068

Brief Summary

This is a randomized controlled clinical trial with three parallel arms. This trial aims to evaluate the effectiveness of electroacupuncture on P6 acupoint for patients with hypertension,with respect to decreasing their blood pressure, safety of acupuncture ,and improving their quality of life as well.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 14, 2020

Completed
18 days until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

August 14, 2020

Status Verified

August 1, 2020

Enrollment Period

5 months

First QC Date

August 11, 2020

Last Update Submit

August 12, 2020

Conditions

Keywords

acupuncture

Outcome Measures

Primary Outcomes (2)

  • Reduction of blood pressure.

    It is expected that both blood pressure and heart rate will be reduced during the electroacupuncture of P6 acupoint.

    up to 6 months

  • Reduction of Heart Rate

    Heart Rate is also expected to be reduced with the stimulation of p6 acupoint.

    up to 6 months

Study Arms (3)

Unilateral electroacupuncture of p6 acupoint

EXPERIMENTAL
Procedure: Acupuncture

Bilateral electroacupuncture of p6 acupoint

EXPERIMENTAL
Procedure: Acupuncture

Sham acupuncture of p6 acupoint

SHAM COMPARATOR
Procedure: Sham acupuncture

Interventions

AcupuncturePROCEDURE

In each session, acupuncture are applied unilaterally or bilaterally on P6 acupoint. Each acupuncture needle will be stimulated by transcutaneous electric device.

Bilateral electroacupuncture of p6 acupointUnilateral electroacupuncture of p6 acupoint

Sham acupuncture

Sham acupuncture of p6 acupoint

Eligibility Criteria

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

You may qualify if:

  • Patients above 18 years old
  • Have not recently had any changes in anti-hypertensive medications
  • Have not recently been discharged from hospital/are stable
  • Is not having any acute infection.

You may not qualify if:

  • Trypanophobia
  • Below 18 years of age
  • Is currently having an acute infection
  • Is unstable or have been discharged recently from hospital
  • Changes made to anti-hypertensive medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ong Fujian Chinese Physician Hall

Singapore, 427513, Singapore

Location

MeSH Terms

Conditions

Hypertension

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Lin Ho Wong, MB BCH BAO

    Ong Fujian Chinese Physician Hall

    STUDY DIRECTOR
  • Pang Ong Wong, PhD

    Ong Fujian Chinese Physician Hall

    PRINCIPAL INVESTIGATOR
  • Eng Soon Ong, Bachelor of TCM

    Ong Fujian Chinese Physician Hall

    STUDY CHAIR
  • Choo Keok Lim, PhD

    Ong Fujian Chinese Physician Hall

    STUDY CHAIR

Central Study Contacts

Lin Ho Wong, MB BCh BAO

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

August 11, 2020

First Posted

August 14, 2020

Study Start

September 1, 2020

Primary Completion

February 1, 2021

Study Completion

April 30, 2021

Last Updated

August 14, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations