Acupuncture Lowering Blood Pressure for Secondary Prevention of Stroke

Cerebral Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02967484
• Other study ID #: 201507001-08
• Status: Recruiting
• Phase: N/A
• First received: July 23, 2016
• Last updated: July 24, 2017
• Start date: November 20, 2016
• Est. completion date: May 2020

Study information

• Verified date: July 2017
• Source: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
• Contact: yuzheng Du
• Phone: 13702088266
• Email: drduyuzheng11[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Infarction
• Infarction

Intervention

Device:
• acupuncture
"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?ßreceptor 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)

Locations

Country	Name	City	State
China	Chongqing Traditional Chinese Medicine Hospital	Chongqing
China	MIANYANG Hospital of Traditional Chinese Medicine	Mianyang
China	LONGHUA Hospital Shanghai University of Traditional Chinese Medicine	Shanghai
China	Shenzhen Bao'an Traditional Chinese Medicine Hospital Group	Shenzhen
China	First Teaching Hospital of Tianjin University of TCM	Tianjin

Sponsors (2)

Lead Sponsor	Collaborator
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine	State Administration of Traditional Chinese Medicine of the People's Republic of China

Country where clinical trial is conducted

China, 

Outcome

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