Acupuncture Lowering Blood Pressure for Secondary Prevention of Stroke

Tianjin University of Traditional Chinese Medicine

Status: Unknown

Conditions: Cerebral Infarction

Treatments: Device: acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT02967484

201507001-08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 480 estimated patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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480 participants in 2 patient groups

Treatment Group

Experimental group

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)

Treatment:

Device: acupuncture

Control Group

No Intervention group

Description:

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)