Acupuncture Lowering Blood Pressure for Secondary Prevention of Stroke: Study Protocol for a Multicenter, Pragmatic,Randomized Controlled, Assessor-blinded Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 480
- 试验地点
- 5
- 主要终点
- The Effects of Acupuncture on Reccurence of Ischemic Stroke
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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)
干预措施: acupuncture (Device)
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)
结局指标
主要结局
The Effects of Acupuncture on Reccurence of Ischemic Stroke
时间窗: 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.
次要结局
- 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)
- 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)
- 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)
研究者
Yuzheng Du
Director
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine