- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04514068
Effect of Electroacupuncture on P6 Acupoint on Hypertensive Patients. (EEP6)
August 12, 2020 updated by: Lin Ho Wong, Ong Fujian Chinese Physician Hall
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Singapore, Singapore, 427513
- Ong Fujian Chinese Physician Hall
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Unilateral electroacupuncture of p6 acupoint
|
In each session, acupuncture are applied unilaterally or bilaterally on P6 acupoint.
Each acupuncture needle will be stimulated by transcutaneous electric device.
|
|
Experimental: Bilateral electroacupuncture of p6 acupoint
|
In each session, acupuncture are applied unilaterally or bilaterally on P6 acupoint.
Each acupuncture needle will be stimulated by transcutaneous electric device.
|
|
Sham Comparator: Sham acupuncture of p6 acupoint
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Sham acupuncture
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reduction of blood pressure.
Time Frame: up to 6 months
|
It is expected that both blood pressure and heart rate will be reduced during the electroacupuncture of P6 acupoint.
|
up to 6 months
|
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Reduction of Heart Rate
Time Frame: up to 6 months
|
Heart Rate is also expected to be reduced with the stimulation of p6 acupoint.
|
up to 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Lin Ho Wong, MB BCH BAO, Ong Fujian Chinese Physician Hall
- Principal Investigator: Pang Ong Wong, PhD, Ong Fujian Chinese Physician Hall
- Study Chair: Eng Soon Ong, Bachelor of TCM, Ong Fujian Chinese Physician Hall
- Study Chair: Choo Keok Lim, PhD, Ong Fujian Chinese Physician Hall
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
September 1, 2020
Primary Completion (Anticipated)
February 1, 2021
Study Completion (Anticipated)
April 30, 2021
Study Registration Dates
First Submitted
August 11, 2020
First Submitted That Met QC Criteria
August 12, 2020
First Posted (Actual)
August 14, 2020
Study Record Updates
Last Update Posted (Actual)
August 14, 2020
Last Update Submitted That Met QC Criteria
August 12, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OngFujianCPH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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