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Acupuncture Lowering Blood Pressure for Secondary Prevention of Stroke

Primary Purpose

Cerebral Infarction

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

acupuncture

About this trial

This is an interventional prevention trial for Cerebral Infarction focused on measuring Acupuncture, Hypertension, Second prevention of Stroke, Efficacy, RCT, Study protocol

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Chongqing Traditional Chinese Medicine Hospital
MIANYANG Hospital of Traditional Chinese Medicine
LONGHUA Hospital Shanghai University of Traditional Chinese Medicine
Shenzhen Bao'an Traditional Chinese Medicine Hospital Group
First Teaching Hospital of Tianjin University of TCMRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment Group

Control Group

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

24-hour ambulatory blood pressure

Daily Blood Pressure by Electronic Sphygmomanometer

Antihypertensive Drug Stop/Resumption/Increasing Rate

Nitric Oxide(NO)

Endothelin(ET)

The Cardiac Color Doppler Ultrasonography

Carotid Color Ultrasonography

Brain Color Doppler Ultrasonography

Lower Extremity Color Ultrasonography

TCM syndrome score

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

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

Essen stroke risk score (ESRS)

All-caused Morality

Serum homocysteine（Hcy）

Soluble CD40L（sCD40L）

Copeptin

Full Information

NCT ID

NCT02967484

First Posted

July 23, 2016

Last Updated

July 24, 2017

Sponsor

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02967484

Brief Title

Acupuncture Lowering Blood Pressure for Secondary Prevention of Stroke

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Unknown status

Study Start Date

November 20, 2016 (Actual)

Primary Completion Date

May 2020 (Anticipated)

Study Completion Date

May 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Collaborators

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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. While the other half will receive 1 antihypertensive medication and basic treatments for ischemic stroke.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebral Infarction

Keywords

Acupuncture, Hypertension, Second prevention of Stroke, Efficacy, RCT, Study protocol

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment Group

Arm Type

Experimental

Arm Description

Arm Title

Control Group

Arm Type

No Intervention

Arm Description

Intervention Type

Device

Intervention Name(s)

acupuncture

Other Intervention Name(s)

drug

Intervention Description

"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). 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). 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)

Primary Outcome Measure Information:

Title

The Effects of Acupuncture on Reccurence of Ischemic Stroke

Description

Time Frame

1 year after enrollment

Secondary Outcome Measure Information:

Title

24-hour ambulatory blood pressure

Time Frame

the first day、6 weeks、12 weeks after enrollment

Title

Daily Blood Pressure by Electronic Sphygmomanometer

Time Frame

1 year after enrollment

Title

Antihypertensive Drug Stop/Resumption/Increasing Rate

Time Frame

1 year after enrollment

Title

Nitric Oxide(NO)

Time Frame

the first day、12 weeks,6 months after enrollment

Title

Endothelin(ET)

Time Frame

the first day、12 weeks,6 months after enrollment

Title

The Cardiac Color Doppler Ultrasonography

Time Frame

the first day、12 weeks after enrollment

Title

Carotid Color Ultrasonography

Time Frame

the first day、12 weeks after enrollment

Title

Brain Color Doppler Ultrasonography

Time Frame

the first day、12 weeks after enrollment

Title

Lower Extremity Color Ultrasonography

Time Frame

the first day、12 weeks after enrollment

Title

TCM syndrome score

Time Frame

the first day、6 weeks、12 weeks after enrollment

Title

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

Time Frame

the first day、6 weeks、12 weeks after enrollment

Title

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

Time Frame

the first day、12 weeks after enrollment

Title

Essen stroke risk score (ESRS)

Time Frame

the first day、1 year after enrollment

Title

All-caused Morality

Time Frame

1 year after enrollment

Title

Serum homocysteine（Hcy）

Time Frame

the first day、12 weeks,6 months after enrollment

Title

Soluble CD40L（sCD40L）

Time Frame

the first day、12 weeks,6 months after enrollment

Title

Copeptin

Time Frame

the first day、12 weeks,6 months after enrollment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

yuzheng Du

Phone

13702088266

drduyuzheng11@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xuemin Shi

Organizational Affiliation

The First Teaching Hospital of Tianjin University of TCM

Official's Role

Study Director

Facility Information:

Facility Name

Chongqing Traditional Chinese Medicine Hospital

City

Chongqing

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhuxing Wang

Phone

+8613883413646

wzhuxing1963@163.com

Facility Name

MIANYANG Hospital of Traditional Chinese Medicine

City

Mianyang

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiuli Yuan

Phone

+8613881109129

13881109129@163.com

Facility Name

LONGHUA Hospital Shanghai University of Traditional Chinese Medicine

City

Shanghai

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jian Pei

Phone

+8618917763082

jianpei99@yahoo.com

Facility Name

Shenzhen Bao'an Traditional Chinese Medicine Hospital Group

City

Shenzhen

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peng Zhou

Phone

+8613714077462

77103698@qq.com

Facility Name

First Teaching Hospital of Tianjin University of TCM

City

Tianjin

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yuzheng Du

Phone

+8613702088266

drduyuzheng11@163.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

28915826

Citation

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.

Results Reference

derived

Learn more about this trial

Acupuncture Lowering Blood Pressure for Secondary Prevention of Stroke

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