Acupuncture Lowering Blood Pressure for Secondary Prevention of Stroke

Not Applicable

• Conditions: Cerebral Infarction
• Interventions: Device: acupuncture

• Registration Number: NCT02967484
• Lead Sponsor: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

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.

Study Timeline

• Study First Submitted: 2016-07-23
• Study First Submitted QC: 2016-11-15
• Study First Posted: 2016-11-18
• Study Start: 2016-11-20
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-24
• Last Update Posted: 2017-07-26
• Primary Completion: 2020-05
• Study Completion: 2020-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 480

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	acupuncture	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)

Primary Outcome Measures

Name	Time	Method
The Effects of Acupuncture on Reccurence of Ischemic Stroke	1 year after enrollment	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

Name	Time	Method
Antihypertensive Drug Stop/Resumption/Increasing Rate	1 year after enrollment
The Cardiac Color Doppler Ultrasonography	the first day、12 weeks after enrollment
National Institute of Health stroke scale (NIHSS)，as well as Barthel Index (BI) scale	the first day、12 weeks after enrollment
24-hour ambulatory blood pressure	the first day、6 weeks、12 weeks after enrollment
Carotid Color Ultrasonography	the first day、12 weeks after enrollment
Brain Color Doppler Ultrasonography	the first day、12 weeks after enrollment
TCM syndrome score	the first day、6 weeks、12 weeks after enrollment
Serum homocysteine（Hcy）	the first day、12 weeks,6 months after enrollment
Daily Blood Pressure by Electronic Sphygmomanometer	1 year after enrollment
Nitric Oxide(NO)	the first day、12 weeks,6 months after enrollment
Copeptin	the first day、12 weeks,6 months after enrollment
Endothelin(ET)	the first day、12 weeks,6 months after enrollment
Lower Extremity Color Ultrasonography	the first day、12 weeks after enrollment
Essen stroke risk score (ESRS)	the first day、1 year after enrollment
All-caused Morality	1 year after enrollment
Short Form 36-item Health Survey (SF-36)	the first day、6 weeks、12 weeks after enrollment
Soluble CD40L（sCD40L）	the first day、12 weeks,6 months after enrollment

Trial Locations

Locations (5)

MIANYANG Hospital of Traditional Chinese Medicine; 🇨🇳 Mianyang, China

Chongqing Traditional Chinese Medicine Hospital; 🇨🇳 Chongqing, China

LONGHUA Hospital Shanghai University of Traditional Chinese Medicine; 🇨🇳 Shanghai, China

First Teaching Hospital of Tianjin University of TCM; 🇨🇳 Tianjin, China

Shenzhen Bao'an Traditional Chinese Medicine Hospital Group; 🇨🇳 Shenzhen, China