Acupuncture Lowering Blood Pressure for Secondary Prevention of Stroke

July 24, 2017 updated by: Yuzheng Du, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

480

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Chongqing, China
        • Not yet recruiting
        • Chongqing Traditional Chinese Medicine Hospital
        • Contact:
      • Mianyang, China
        • Not yet recruiting
        • MIANYANG Hospital of Traditional Chinese Medicine
        • Contact:
      • Shanghai, China
        • Not yet recruiting
        • Longhua Hospital Shanghai University of Traditional Chinese Medicine
        • Contact:
      • Shenzhen, China
        • Not yet recruiting
        • Shenzhen Bao'an Traditional Chinese Medicine Hospital Group
        • Contact:
      • Tianjin, China
        • Recruiting
        • First Teaching Hospital of Tianjin University of TCM
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
Device: acupuncture
  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)

Other Names:
  • drug
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year after enrollment

Secondary Outcome Measures

Outcome Measure
Time Frame
24-hour ambulatory blood pressure
Time Frame: the first day、6 weeks、12 weeks after enrollment
the first day、6 weeks、12 weeks after enrollment
Daily Blood Pressure by Electronic Sphygmomanometer
Time Frame: 1 year after enrollment
1 year after enrollment
Antihypertensive Drug Stop/Resumption/Increasing Rate
Time Frame: 1 year after enrollment
1 year after enrollment
Nitric Oxide(NO)
Time Frame: the first day、12 weeks,6 months after enrollment
the first day、12 weeks,6 months after enrollment
Endothelin(ET)
Time Frame: the first day、12 weeks,6 months after enrollment
the first day、12 weeks,6 months after enrollment
The Cardiac Color Doppler Ultrasonography
Time Frame: the first day、12 weeks after enrollment
the first day、12 weeks after enrollment
Carotid Color Ultrasonography
Time Frame: the first day、12 weeks after enrollment
the first day、12 weeks after enrollment
Brain Color Doppler Ultrasonography
Time Frame: the first day、12 weeks after enrollment
the first day、12 weeks after enrollment
Lower Extremity Color Ultrasonography
Time Frame: the first day、12 weeks after enrollment
the first day、12 weeks after enrollment
TCM syndrome score
Time Frame: the first day、6 weeks、12 weeks after enrollment
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
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
the first day、12 weeks after enrollment
Essen stroke risk score (ESRS)
Time Frame: the first day、1 year after enrollment
the first day、1 year after enrollment
All-caused Morality
Time Frame: 1 year after enrollment
1 year after enrollment
Serum homocysteine（Hcy）
Time Frame: the first day、12 weeks,6 months after enrollment
the first day、12 weeks,6 months after enrollment
Soluble CD40L（sCD40L）
Time Frame: the first day、12 weeks,6 months after enrollment
the first day、12 weeks,6 months after enrollment
Copeptin
Time Frame: the first day、12 weeks,6 months after enrollment
the first day、12 weeks,6 months after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Collaborators

State Administration of Traditional Chinese Medicine of the People's Republic of China

Investigators

  • Study Director: Xuemin Shi, The First Teaching Hospital of Tianjin University of TCM

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2016

Primary Completion (Anticipated)

May 1, 2020

Study Completion (Anticipated)

May 1, 2020

Study Registration Dates

First Submitted

July 23, 2016

First Submitted That Met QC Criteria

November 15, 2016

First Posted (Estimate)

November 18, 2016

Study Record Updates

Last Update Posted (Actual)

July 26, 2017

Last Update Submitted That Met QC Criteria

July 24, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201507001-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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