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Essential HypertensionPhase 3EAPMHNCT01701726

Effect of Acupuncture on Patients With Mild Hypertension

A Phase 3 study testing acupuncture in people with Essential Hypertension, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a large scale, open-label, multicenter, randomized controlled clinical trial with four parallel arms. This trial aims to evaluate the effectiveness of affected meridian acupuncture for patients with mild hypertension,with respect to decreasing their blood pressure, safety of acupuncture ,and improving their… Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Essential Hypertension
What is being tested?
acupuncture
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
400 participants
Where
1 siteChina
Study dates
Jul 2012to Apr 2016
Phase
Phase 3
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 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients whose age between 40 and 75 years old, male and female;
  • Patients who meet the diagnostic criteria of mild hypertension according to JNC-7 and China's prevention and cure guide of hypertension. mild hypertension (WHO/ISH criteria stage I) Systolic blood pressure 159≥(SBP) ≥140 and/or diastolic blood pressure 99≥(DBP) ≥90 .
  • Patients who are initially diagnosed as mild hypertension or have been diagnosed as mild hypertension before but have not taken any antihypertensive drugs.
  • Patients who are diagnosed as yue-yin style (yin-deficiency accompany with hyperactivity of yang) or yang-ming style (obstruction of phlegm and dampness) according to meridian syndrome differentiation
  • Patients who have a good understanding of our study. and willing to comply with our study protocol.
  • Informed consent form must be signed by patient or lineal relative.
  • All the tips are matched will be included.

Who cannot join

  • Patients who have been diagnosed as secondary hypertension or malignant hypertension(e.g. Cushing's syndrome, coarctation of the aorta，phaeochromocytoma, renal parenchymal disease，primary aldosteronism， renovascular hypertension, obstructive sleep apnoea，drug induced hypertension et al )
  • Patients who accompany with other severe medical conditions (e.g. endocrine disorders, cardiovascular disease. Digestive disease. hepatic dysfunction，cerebral vascular disease. renal disease. haematologic disease et al). Who may be not safe to join our study.
  • Patients with a chronic disease which might not suitable for our study. e.g: epilepsy ,severe depression or anxiety (SAS≥70,SDS≥70) ,psychosis, allergic constitution, accompany with any infection.
  • Pregnant women or women in lactation or women of child bearing potential plan to conceive in the recent six months.
  • Patients who currently participate in another clinical trial.
  • Patients who Had been treated with acupuncture during the previous three months
  • If one of the tips mentioned above is matched will be excluded.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Chengdu University of Traditional Chinese Medicine

    Chengdu, Sichuan, 610075

Other trials in China

About this study

Official title: Acupuncture for Patients With Mild Hypertension: Study Protocol of an Open-label Multicenter Randomized Controlled Trial

This is a large scale, open-label, multicenter, randomized controlled clinical trial with four parallel arms. This trial aims to evaluate the effectiveness of affected meridian acupuncture for patients with mild hypertension,with respect to decreasing their blood pressure, safety of acupuncture ,and improving their quality of life as well.

Read the detailed description

Investigators plan to recruit 428 hypertensive patients. Eligible patients will be randomized to four different groups.ⅰ. the affected meridian acupuncture group (AMA, n=107) will be treated with acupoints on affected meridians.ⅱ.the non-affected meridian acupuncture group (NMA, n=107) will be treated with acupoints on non-affected meridians.ⅲ.invasive sham acupuncture group(ISA, n=107)will be provided with sham acupoints treatment.ⅳ.waiting-list group(WL, n=107)will not be given any intervention.

Being tested
acupuncture, Sham acupuncture
Keywords
Essential Hypertension, Acupuncture, Specificity, Acupoints effect, randomized controlled trials
Medical subject headings
Essential Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • acupunctureOther

    Also called electroacupuncture

    In each session, acupuncture are applied bilaterally. Except the acupoints around the neck(ST9.GB20.non-acupoints 4) ,6 auxiliary needles will be punctured at 2mm lateral to each acupoints or non-acupoints.as to auxiliary needle we will not do any manipulation. We use transcutaneous electric acupoints stimulation to stimulate the acupoints and non-acupoints.

  • Sham acupunctureOther

    In contrast to acupuncture, sham acupuncture is given at 4 sham points with skin penetration. Electroacupuncture is also applied.

Study groups in NCT01701726
Study groupRoleWhat they receive
AcupunctureExperimentalTwo types of acupuncture are given, one is acupuncture at affected meridian points, the other is at non-affected. For the first type, We select the acupoints from the affected meridians.Patients in this group are divided into two subgroups according meridian syndrome differentiation(jue-yin style,yang-ming style).Patients pertaining to Jue-yin-style are treated with taichong (LR3), renying(ST9), taixi(KI3), neiguan(PC6) .Patients pertaining to Yang-ming-style: taichong(LR3), renying(ST9), zusanli(ST36), quchi(LI11). For the second,We select the acupoints from the non-affected meridians.Patients assigned into the non-affected meridian acupuncture group will be treated with Fengchi (GB20), waiguan(SJ5), yinlingquan(SP9), xuehai (SP10).
Receives: Other: acupuncture
Sham acupunctureSham comparatorwe use sham acupoints: 1. The edge of the tibia (1-2cm lateral and horizontal to the zusanli (ST36)) 2. Half way between the tip of the elbow and the axilla 3. On the ulnar side of the arm, half way between the epicondylus medialis of the humerus and the ulnar side of the wrist. 4. 2cm superior to fu tu(LI18)
Receives: Other: Sham acupuncture
Waiting listNo interventionParticipants who will be randomized into the waiting-list group will not receive any acupuncture treatment throughout 13-week observation period. At the end of trial, if the participant would like to be treated with acupuncture, it will be provided three times weekly for 6 weeks.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Average systolic and average diastolic blood pressure by 24-hour ambulatory blood pressure monitoring

    The primary outcome is the average systolic and average diastolic blood pressure measured at 6 weeks after randomization by 24-hour ambulatory blood pressure monitoring.

    Measured: 6weeks after randomization.

  2. Visit-to-visit blood pressure variation

    Assessed by 24-hour ambulatory blood pressure monitoring

    Measured: 6 weeks after randomization

Secondary outcomes (4)

  1. Average systolic and average diastolic blood pressure during the daytime and nighttime.

    The daytime is from 8AM to 10PM,nighttime is 10PM -8AM.

    Measured: 0 day, 6weeks, 9weeks, 12weeks after randomization.

  2. Average systolic and average diastolic blood pressure during the daytime and nighttime.

    The daytime is defined as 8AM-10PM.Nighttime is defined as 10PM -8AM.

    Measured: 0 day, 6weeks, 9weeks, 12weeks after randomization.

  3. changes in patients health-related quality of life

    SF-36 (Medical Outcomes Study 36-Item Short Form)questionnaire Chinese version. The scale contains eight dimensions (physical function, role physical, bodily pain, general health, vitality, social function, role emotional, mental health) and two summary components (physical and mental ),scale 0-100.lower scores indicate poorer quality of life.

    Measured: 0 day and 6 weeks after randomization.

  4. Adverse events

    Adverse events are defined as any unexpected or discomfort signs, symptoms or diseases, regardless of the intervention. If any adverse events happen during the entire observation period, all the details should be documented in the case report form. These adverse events include bleeding, hematoma, fainting, serious pain, and local infection.

    Measured: 0 day, 6weeks, 9weeks, 12weeks after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionFeb 2016
  4. Study completionApr 2016

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01701726
Sponsor's protocol ID
2012CB518501-1
Acronym
EAPMH
Status last verified
Jun 2016
First submitted
26 Sep 2012
Last updated
21 Jun 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Wang JM, Yang MX, Wu QF, Chen J, Deng SF, Chen L, Wei DN, Liang FR. Improvement of intestinal flora: accompany with the antihypertensive effect of electroacupuncture on stage 1 hypertension. Chin Med. 2021 Jan 7;16(1):7. doi: 10.1186/s13020-020-00417-8.

    PubMed 33413552

  • Li J, Zheng H, Zhao L, Li Y, Zhang Y, Chang XR, Wang RH, Shi J, Cui J, Huang YL, Li X, Chen J, Li DH, Liang FR. Acupuncture for patients with mild hypertension: study protocol of an open-label multicenter randomized controlled trial. Trials. 2013 Nov 11;14:380. doi: 10.1186/1745-6215-14-380.

    PubMed 24216113

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing acupuncture in people with Essential Hypertension, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.

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 7 inclusion and 7 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: finished, as of the sponsor's last update on 21 Jun 2016. 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 China. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average systolic and average diastolic blood pressure by 24-hour ambulatory blood pressure monitoring (time frame: 6weeks after randomization.). 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?

On the ClinicalTrials.gov record for NCT01701726, which also lists 2 linked publications.

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 21 Jun 2016; AzTrials last refreshed its copy on 7 Nov 2026.

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