search
Back to results

Effect of Electroacupuncture on P6 Acupoint on Hypertensive Patients. (EEP6)

Primary Purpose

Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Acupuncture
Sham acupuncture
Sponsored by
Ong Fujian Chinese Physician Hall
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring acupuncture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Ong Fujian Chinese Physician Hall

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Unilateral electroacupuncture of p6 acupoint

Bilateral electroacupuncture of p6 acupoint

Sham acupuncture of p6 acupoint

Arm Description

Outcomes

Primary Outcome Measures

Reduction of blood pressure.
It is expected that both blood pressure and heart rate will be reduced during the electroacupuncture of P6 acupoint.
Reduction of Heart Rate
Heart Rate is also expected to be reduced with the stimulation of p6 acupoint.

Secondary Outcome Measures

Full Information

First Posted
August 11, 2020
Last Updated
August 12, 2020
Sponsor
Ong Fujian Chinese Physician Hall
search

1. Study Identification

Unique Protocol Identification Number
NCT04514068
Brief Title
Effect of Electroacupuncture on P6 Acupoint on Hypertensive Patients.
Acronym
EEP6
Official Title
Effect of Electroacupuncture on P6 Acupoint on Hypertensive Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Anticipated)
Primary Completion Date
February 1, 2021 (Anticipated)
Study Completion Date
April 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ong Fujian Chinese Physician Hall

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
acupuncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Unilateral electroacupuncture of p6 acupoint
Arm Type
Experimental
Arm Title
Bilateral electroacupuncture of p6 acupoint
Arm Type
Experimental
Arm Title
Sham acupuncture of p6 acupoint
Arm Type
Sham Comparator
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Description
In each session, acupuncture are applied unilaterally or bilaterally on P6 acupoint. Each acupuncture needle will be stimulated by transcutaneous electric device.
Intervention Type
Procedure
Intervention Name(s)
Sham acupuncture
Intervention Description
Sham acupuncture
Primary Outcome Measure Information:
Title
Reduction of blood pressure.
Description
It is expected that both blood pressure and heart rate will be reduced during the electroacupuncture of P6 acupoint.
Time Frame
up to 6 months
Title
Reduction of Heart Rate
Description
Heart Rate is also expected to be reduced with the stimulation of p6 acupoint.
Time Frame
up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lin Ho Wong, MB BCh BAO
Phone
+6582992667
Email
nate.wong90@live.com.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin Ho Wong, MB BCH BAO
Organizational Affiliation
Ong Fujian Chinese Physician Hall
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Pang Ong Wong, PhD
Organizational Affiliation
Ong Fujian Chinese Physician Hall
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eng Soon Ong, Bachelor of TCM
Organizational Affiliation
Ong Fujian Chinese Physician Hall
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Choo Keok Lim, PhD
Organizational Affiliation
Ong Fujian Chinese Physician Hall
Official's Role
Study Chair
Facility Information:
Facility Name
Ong Fujian Chinese Physician Hall
City
Singapore
ZIP/Postal Code
427513
Country
Singapore
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Ho Wong, MB BCh BAO
Phone
82992667

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Electroacupuncture on P6 Acupoint on Hypertensive Patients.

We'll reach out to this number within 24 hrs