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Cerebral InfarctionNCT02967484

Acupuncture Lowering Blood Pressure for Secondary Prevention of Stroke

A study testing acupuncture in people with Cerebral Infarction, run by First Teaching Hospital of Tianjin University of Traditional Chinese Medicine at 5 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study evaluate the effects of acupuncture method on the recurrence of ischemic stroke patients.Half of participants will receive "Huo Xue San Feng" acupuncture combining 1 antihypertensive medication on the routine ischemic stroke treatments' basis. Read more about this study

Who is it for?
Ages 35 to 75 years
Conditions the study is for
Cerebral Infarction
What is being tested?
acupuncture
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
480 participants
Where
5 sitesChina
Study dates
20 Nov 2016to May 2020
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 35 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with the first time ischemic stroke
  • Patients meet the TCM diagnosis standard of Stroke
  • Patients meet the diagnosis standard of hypertension, taking only 1 type of antihypertensive drugs for at least 2 weeks before admission,corresponding to systolic pressure ranging from 140 to 160mmHg and Diastolic ranging from 90-100mmHg.
  • The course of Ischemic stroke ranging from 2 weeks to 6 weeks .
  • Men or Women Aged between 35 and 70 years old.
  • Patients who are willing to participate in our clinical trial agree to sign the informed consent form.

Who cannot join

  • Patients who have been diagnosed with secondary hypertension.
  • Patients have taken beta blockers or diuretics or non dihydropyridine calcium channel blocker （NDHP-CCB）for a long time because of cardiovascular disease.
  • Patients who taking 1 type of antihypertensive drugs,blood pressure under 140/90mmHg.
  • Patients accompanied with other neurological disorders,such as epilepsy, peripheral nerve injury,
  • Patients accompanied with severe medical condition such as severe hematopoietic system disease, coagulation dysfunction and malignant tumor.
  • Patients accompanied with diabetic nephropathy,severe liver and renal insufficiency,severe cardiac or pulmonary dysfunction,severe arrhythmia.
Show all 9Show fewer
  • Patients who have occured skin infections near the acupoint location.
  • Pregnant or breast-feeding women.
  • Patients who currently participate in another clinical trial.

Trial locations and contacts

5 sites in 1 country.

yuzheng Du contact

13702088266

drduyuzheng11@163.com

5 sites in 1 country

China5 sites, 5 recruiting

  • Chongqing Traditional Chinese Medicine Hospital

    Chongqing

    Zhuxing Wang, +8613883413646, wzhuxing1963@163.com

    Not yet recruiting

  • MIANYANG Hospital of Traditional Chinese Medicine

    Mianyang

    Xiuli Yuan, +8613881109129, 13881109129@163.com

    Not yet recruiting

  • LONGHUA Hospital Shanghai University of Traditional Chinese Medicine

    Shanghai

    Jian Pei, +8618917763082, jianpei99@yahoo.com

    Not yet recruiting

  • Shenzhen Bao'an Traditional Chinese Medicine Hospital Group

    Shenzhen

    Peng Zhou, +8613714077462, 77103698@qq.com

    Not yet recruiting

  • First Teaching Hospital of Tianjin University of TCM

    Tianjin

    Yuzheng Du, +8613702088266, drduyuzheng11@163.com

    Recruiting

Other trials in China

About this study

Official title: Acupuncture Lowering Blood Pressure for Secondary Prevention of Stroke: Study Protocol for a Multicenter, Pragmatic,Randomized Controlled, Assessor-blinded Clinical Trial

This study evaluate the effects of acupuncture method on the recurrence of ischemic stroke patients.Half of participants will receive "Huo Xue San Feng" acupuncture combining 1 antihypertensive medication on the routine ischemic stroke treatments' basis. While the other half will receive 1 antihypertensive medication and basic treatments for ischemic stroke.

Read the detailed description

Under recuiting 480 patients come from 5 hospitals in China.Eligible patients will be randomly assigned into 2 groups: treatment group and control group. The treatment group will receive "Huo Xue San Feng" acupuncture combining 1 antihypertensive medication on the routine ischemic stroke treatments' basis. The control group will receive 1 antihypertensive medication and basic treatments for ischemic stroke. "Huo Xue San Feng" acupuncture will be given six sessions weekly for the first 6 weeks and three times weekly for the next 6 weeks. A 9-month follow-up will thereafter be conducted. Antihypertensive medications will be adjusted based on BP levels.

Being tested
acupuncture
Keywords
Acupuncture, Hypertension, Second prevention of Stroke, Efficacy, RCT, Study protocol
Medical subject headings
Cerebral Infarction, Hypertension

What participants receive

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

  • acupunctureDevice

    Also called drug

    1. "Huo Xue San Feng" acupuncture method: Patients will recieve the acupuncture treatment,choose the bilateral point:Renying(ST9),Hegu(L14),Taichong(LR3),Quchi(LI11),Zusanli(ST36).
    2. Routine care for ischemic stroke :patients will recieve the acupuncture treatment,choose the point:Neiguan(PC6),Renzhong(10),Sanyinjiao(SP6),Jiquan(HT1),Chize(LU5),Weizhong(BL40).
    3. Drugs: Antihypertensive drugs.Patients will be treated 1 of 5 type of antihypertensive drugs,include ARB、ACEI、βreceptor blocker,CCB,Diuretic.

    The time of therapy will consist of 6 times per week in Continuous treatment phase(1st-6th week after enrollment) and 3 times per week(once every other day) in Consolidation treatment phase(7th-tewlve week after enrollment)

Study groups in NCT02967484
Study groupRoleWhat they receive
Treatment GroupExperimentalParticipants will recieve the therapy as follows: "Huo Xue San Feng" acupuncture method+Routine care for ischemic stroke+One type of antihypertensive medication. Intervention:Acupuncture(choosing the bilatral acupoint: Renying(ST9),Hegu(L14), Taichong(LR3),Quchi(LI11),Zusanli(ST36))+Drugs(one type of antihypertensive medicine)
Receives: Device: acupuncture
Control GroupNo interventionParticipants recieve the therapy as follows:Routine care for ischemic stroke +One type of antihypertensive medication. Intervention:Acupuncture(choosing the acupoint: Neiguan(PC6),Renzhong(10), Sanyinjiao(SP6),Jiquan(HT1),Chize(LU5),Weizhong(BL40).)+Drugs(one type of antihypertensive medicine)

What is being measured

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

  1. The Effects of Acupuncture on Reccurence of Ischemic Stroke

    The effects of acupuncture on reccurence of ischemic stroke assessed by China's Guidelines of Diagnosis and Treatment of Acute Ischemic Stroke 2014 and China's Guidelines of Diagnosis and Treatment of Cerebral Hemorrhage 2014.

    Measured: 1 year after enrollment

Secondary outcomes (17)

  1. 24-hour ambulatory blood pressure

    Measured: the first day、6 weeks、12 weeks after enrollment

  2. Daily Blood Pressure by Electronic Sphygmomanometer

    Measured: 1 year after enrollment

  3. Antihypertensive Drug Stop/Resumption/Increasing Rate

    Measured: 1 year after enrollment

  4. Nitric Oxide(NO)

    Measured: the first day、12 weeks,6 months after enrollment

  5. Endothelin(ET)

    Measured: the first day、12 weeks,6 months after enrollment

  6. The Cardiac Color Doppler Ultrasonography

    Measured: the first day、12 weeks after enrollment

  7. Carotid Color Ultrasonography

    Measured: the first day、12 weeks after enrollment

  8. Brain Color Doppler Ultrasonography

    Measured: the first day、12 weeks after enrollment

  9. Lower Extremity Color Ultrasonography

    Measured: the first day、12 weeks after enrollment

  10. TCM syndrome score

    Measured: the first day、6 weeks、12 weeks after enrollment

  11. Short Form 36-item Health Survey (SF-36)

    Measured: the first day、6 weeks、12 weeks after enrollment

  12. National Institute of Health stroke scale (NIHSS)，as well as Barthel Index (BI) scale

    Measured: the first day、12 weeks after enrollment

  13. Essen stroke risk score (ESRS)

    Measured: the first day、1 year after enrollment

  14. All-caused Morality

    Measured: 1 year after enrollment

  15. Serum homocysteine（Hcy）

    Measured: the first day、12 weeks,6 months after enrollment

  16. Soluble CD40L（sCD40L）

    Measured: the first day、12 weeks,6 months after enrollment

  17. Copeptin

    Measured: the first day、12 weeks,6 months after enrollment

Timeline

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

  1. First posted18 Nov 2016 (estimated)
  2. Study start20 Nov 2016
  3. Primary completionMay 2020 (estimated)
  4. Study completionMay 2020 (estimated)

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 N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
480 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02967484
Sponsor's protocol ID
201507001-08
Status last verified
Jul 2017
First submitted
23 Jul 2016
Last updated
26 Jul 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Liu W, Li B, Rong M, Li C, Zhao Q, Zhang L, Tan X, He Q, Ban H, Meng X, Gu W, Gao X, Ma F, Ou M, Shi X, Du Y. Effect of acupuncture on ischemic stroke patients with hypertension: a randomized clinical trail. Front Neurol. 2026 Apr 1;17:1717706. doi: 10.3389/fneur.2026.1717706. eCollection 2026.

    PubMed 41993641

  • Du YZ, Gao XX, Wang CT, Zheng HZ, Lei Y, Wu MH, Shi XM, Ban HP, Gu WL, Meng XG, Wei MT, Hu CX. Acupuncture lowering blood pressure for secondary prevention of stroke: a study protocol for a multicenter randomized controlled trial. Trials. 2017 Sep 15;18(1):428. doi: 10.1186/s13063-017-2171-5.

    PubMed 28915826

Questions about this trial

What is this clinical trial studying?

A study testing acupuncture in people with Cerebral Infarction, run by First Teaching Hospital of Tianjin University of Traditional Chinese Medicine at 5 sites 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 6 inclusion and 9 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 26 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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. 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 yuzheng Du (13702088266, drduyuzheng11@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Effects of Acupuncture on Reccurence of Ischemic Stroke (time frame: 1 year after enrollment). 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 NCT02967484, 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 26 Jul 2017.

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