HypertensionEEP6NCT04514068
Effect of Electroacupuncture on P6 Acupoint on Hypertensive Patients.
A study testing Acupuncture in people with Hypertension, run by Ong Fujian Chinese Physician Hall at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Sep 2020to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Singapore1 site
Ong Fujian Chinese Physician Hall
Singapore, 427513
Lin Ho Wong, MB BCh BAO, 82992667
About this study
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.
- Conditions
- Hypertension
- Being tested
- Acupuncture, Sham acupuncture
- Keywords
- acupuncture
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
In each session, acupuncture are applied unilaterally or bilaterally on P6 acupoint. Each acupuncture needle will be stimulated by transcutaneous electric device.
Sham acupunctureProcedure or surgery
Sham acupuncture
| Study group | Role | What they receive |
|---|---|---|
| Unilateral electroacupuncture of p6 acupoint | Experimental | Not described Receives: Procedure: Acupuncture |
| Bilateral electroacupuncture of p6 acupoint | Experimental | Not described Receives: Procedure: Acupuncture |
| Sham acupuncture of p6 acupoint | Sham comparator | Not described Receives: Procedure: Sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of blood pressure.
It is expected that both blood pressure and heart rate will be reduced during the electroacupuncture of P6 acupoint.
Measured: up to 6 months
Reduction of Heart Rate
Heart Rate is also expected to be reduced with the stimulation of p6 acupoint.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start1 Sep 2020 (estimated)
- Primary completion1 Feb 2021 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ong Fujian Chinese Physician Hall
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Ho Wong, Ong Fujian Chinese Physician Hall
- Investigators
- Lin Ho Wong, MB BCH BAO, Study director, Ong Fujian Chinese Physician HallPang Ong Wong, PhD, Principal investigator, Ong Fujian Chinese Physician HallEng Soon Ong, Bachelor of TCM, Study chair, Ong Fujian Chinese Physician HallChoo Keok Lim, PhD, Study chair, Ong Fujian Chinese Physician Hall
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04514068
- Sponsor's protocol ID
- OngFujianCPH
- Acronym
- EEP6
- Status last verified
- Aug 2020
- First submitted
- 11 Aug 2020
- Last updated
- 14 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Electroacupuncture on P6 Acupoint on Hypertensive Patients.
- ClinicalTrials.gov ID
- NCT04514068
- Acronym / sponsor ID
- EEP6 / OngFujianCPH
- Conditions
- Hypertension
- Keywords
- acupuncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ong Fujian Chinese Physician HallUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 1 Feb 2021 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 14 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureIn each session, acupuncture are applied unilaterally or bilaterally on P6 acupoint. Each acupuncture needle will be stimulated by transcutaneous electric device. | Procedure or surgery | Bilateral electroacupuncture of p6 acupoint, Unilateral electroacupuncture of p6 acupoint |
| Sham acupunctureSham acupuncture | Procedure or surgery | Sham acupuncture of p6 acupoint |
Primary outcome
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.
Reduction of Heart Rate
Time frame: up to 6 months
Heart Rate is also expected to be reduced with the stimulation of p6 acupoint.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lin Ho Wong, MB BCH BAO study director
Ong Fujian Chinese Physician Hall
Pang Ong Wong, PhD principal investigator
Ong Fujian Chinese Physician Hall
Eng Soon Ong, Bachelor of TCM study chair
Ong Fujian Chinese Physician Hall
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Hypertension, run by Ong Fujian Chinese Physician Hall at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lin Ho Wong, MB BCh BAO (+6582992667, nate.wong90@live.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of blood pressure. (time frame: up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2020.