Cerebral Infarction
Conditions
Keywords
Acupuncture, Hypertension, Second prevention of Stroke, Efficacy, RCT, Study protocol
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.
Interventions
DEVICEacupuncture
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)
Sponsors
State Administration of Traditional Chinese Medicine of the People's Republic of China
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Daily Blood Pressure by Electronic Sphygmomanometer | 1 year after enrollment |
| Antihypertensive Drug Stop/Resumption/Increasing Rate | 1 year after enrollment |
| Nitric Oxide(NO) | the first day、12 weeks,6 months after enrollment |
| Endothelin(ET) | the first day、12 weeks,6 months after enrollment |
| The Cardiac Color Doppler Ultrasonography | the first day、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 |
| Lower Extremity Color Ultrasonography | the first day、12 weeks after enrollment |
| 24-hour ambulatory blood pressure | the first day、6 weeks、12 weeks after enrollment |
| Short Form 36-item Health Survey (SF-36) | the first day、6 weeks、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 |
| Essen stroke risk score (ESRS) | the first day、1 year after enrollment |
| All-caused Morality | 1 year after enrollment |
| Serum homocysteine（Hcy） | the first day、12 weeks,6 months after enrollment |
| Soluble CD40L（sCD40L） | the first day、12 weeks,6 months after enrollment |
| Copeptin | the first day、12 weeks,6 months after enrollment |
| TCM syndrome score | the first day、6 weeks、12 weeks after enrollment |
Countries
China
Contacts
Primary Contactyuzheng Du
Outcome results
None listed