Acupuncture Lowering Blood Pressure for Secondary Prevention of Stroke

NCT ID: NCT02967484

Last Updated: 2017-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-20

Study Completion Date

2020-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cerebral Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Treatment Group

Participants 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)

Group Type EXPERIMENTAL

acupuncture

Intervention Type DEVICE

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)

Control Group

Participants 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)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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acupuncture

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)

Intervention Type DEVICE

Other Intervention Names

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drug

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
* Patients who have occured skin infections near the acupoint location.
* Pregnant or breast-feeding women.
* Patients who currently participate in another clinical trial.
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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State Administration of Traditional Chinese Medicine of the People's Republic of China

OTHER_GOV

Sponsor Role collaborator

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Yuzheng Du

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xuemin Shi

Role: STUDY_DIRECTOR

The First Teaching Hospital of Tianjin University of TCM

Locations

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Chongqing Traditional Chinese Medicine Hospital

Chongqing, , China

Site Status NOT_YET_RECRUITING

MIANYANG Hospital of Traditional Chinese Medicine

Mianyang, , China

Site Status NOT_YET_RECRUITING

LONGHUA Hospital Shanghai University of Traditional Chinese Medicine

Shanghai, , China

Site Status NOT_YET_RECRUITING

Shenzhen Bao'an Traditional Chinese Medicine Hospital Group

Shenzhen, , China

Site Status NOT_YET_RECRUITING

First Teaching Hospital of Tianjin University of TCM

Tianjin, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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yuzheng Du

Role: CONTACT

13702088266

Facility Contacts

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Zhuxing Wang

Role: primary

+8613883413646

Xiuli Yuan

Role: primary

+8613881109129

Jian Pei

Role: primary

+8618917763082

Peng Zhou

Role: primary

+8613714077462

Yuzheng Du

Role: primary

+8613702088266

References

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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.

Reference Type DERIVED
PMID: 28915826 (View on PubMed)

Other Identifiers

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201507001-08

Identifier Type: -

Identifier Source: org_study_id

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