Acupuncture Lowering Blood Pressure for Secondary Prevention of Stroke

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Participant)
  • Study Primary Completion Date: May 2020

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

  • 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、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)

Arms, Groups and Cohorts

  • Experimental: 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)
  • No Intervention: 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)

Clinical Trial Outcome Measures

Primary Measures

  • The Effects of Acupuncture on Reccurence of Ischemic Stroke
    • Time Frame: 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 Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 35 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
  • Collaborator
    • State Administration of Traditional Chinese Medicine of the People’s Republic of China
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yuzheng Du, Director – First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
  • Overall Official(s)
    • Xuemin Shi, Study Director, The First Teaching Hospital of Tianjin University of TCM
  • Overall Contact(s)
    • yuzheng Du, 13702088266, drduyuzheng11@163.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.