<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02967484</url>
  </required_header>
  <id_info>
    <org_study_id>201507001-08</org_study_id>
    <nct_id>NCT02967484</nct_id>
  </id_info>
  <brief_title>Acupuncture Lowering Blood Pressure for Secondary Prevention of Stroke</brief_title>
  <official_title>Acupuncture Lowering Blood Pressure for Secondary Prevention of Stroke: Study Protocol for a Multicenter, Pragmatic,Randomized Controlled, Assessor-blinded Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Teaching Hospital of Tianjin University of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>State Administration of Traditional Chinese Medicine of the People's Republic of China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>First Teaching Hospital of Tianjin University of Traditional Chinese Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluate the effects of acupuncture method on the recurrence of ischemic stroke&#xD;
      patients.Half of participants will receive &quot;Huo Xue San Feng&quot; acupuncture combining 1&#xD;
      antihypertensive medication on the routine ischemic stroke treatments' basis. While the other&#xD;
      half will receive 1 antihypertensive medication and basic treatments for ischemic stroke.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Under recuiting 480 patients come from 5 hospitals in China.Eligible patients will be&#xD;
      randomly assigned into 2 groups: treatment group and control group. The treatment group will&#xD;
      receive &quot;Huo Xue San Feng&quot; acupuncture combining 1 antihypertensive medication on the routine&#xD;
      ischemic stroke treatments' basis. The control group will receive 1 antihypertensive&#xD;
      medication and basic treatments for ischemic stroke. &quot;Huo Xue San Feng&quot; acupuncture will be&#xD;
      given six sessions weekly for the first 6 weeks and three times weekly for the next 6 weeks.&#xD;
      A 9-month follow-up will thereafter be conducted. Antihypertensive medications will be&#xD;
      adjusted based on BP levels.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 20, 2016</start_date>
  <completion_date type="Anticipated">May 2020</completion_date>
  <primary_completion_date type="Anticipated">May 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Effects of Acupuncture on Reccurence of Ischemic Stroke</measure>
    <time_frame>1 year after enrollment</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>24-hour ambulatory blood pressure</measure>
    <time_frame>the first day、6 weeks、12 weeks after enrollment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily Blood Pressure by Electronic Sphygmomanometer</measure>
    <time_frame>1 year after enrollment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antihypertensive Drug Stop/Resumption/Increasing Rate</measure>
    <time_frame>1 year after enrollment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nitric Oxide(NO)</measure>
    <time_frame>the first day、12 weeks,6 months after enrollment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endothelin(ET)</measure>
    <time_frame>the first day、12 weeks,6 months after enrollment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Cardiac Color Doppler Ultrasonography</measure>
    <time_frame>the first day、12 weeks after enrollment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Carotid Color Ultrasonography</measure>
    <time_frame>the first day、12 weeks after enrollment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brain Color Doppler Ultrasonography</measure>
    <time_frame>the first day、12 weeks after enrollment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lower Extremity Color Ultrasonography</measure>
    <time_frame>the first day、12 weeks after enrollment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TCM syndrome score</measure>
    <time_frame>the first day、6 weeks、12 weeks after enrollment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Form 36-item Health Survey (SF-36)</measure>
    <time_frame>the first day、6 weeks、12 weeks after enrollment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>National Institute of Health stroke scale (NIHSS)，as well as Barthel Index (BI) scale</measure>
    <time_frame>the first day、12 weeks after enrollment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Essen stroke risk score (ESRS)</measure>
    <time_frame>the first day、1 year after enrollment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-caused Morality</measure>
    <time_frame>1 year after enrollment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum homocysteine（Hcy）</measure>
    <time_frame>the first day、12 weeks,6 months after enrollment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Soluble CD40L（sCD40L）</measure>
    <time_frame>the first day、12 weeks,6 months after enrollment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Copeptin</measure>
    <time_frame>the first day、12 weeks,6 months after enrollment</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">480</enrollment>
  <condition>Cerebral Infarction</condition>
  <arm_group>
    <arm_group_label>Treatment Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will recieve the therapy as follows: &quot;Huo Xue San Feng&quot; acupuncture method+Routine care for ischemic stroke+One type of antihypertensive medication.&#xD;
Intervention:Acupuncture(choosing the bilatral acupoint: Renying(ST9),Hegu(L14), Taichong(LR3),Quchi(LI11),Zusanli(ST36))+Drugs(one type of antihypertensive medicine)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants recieve the therapy as follows:Routine care for ischemic stroke +One type of antihypertensive medication.&#xD;
Intervention:Acupuncture(choosing the acupoint: Neiguan(PC6),Renzhong(10), Sanyinjiao(SP6),Jiquan(HT1),Chize(LU5),Weizhong(BL40).)+Drugs(one type of antihypertensive medicine)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>acupuncture</intervention_name>
    <description>&quot;Huo Xue San Feng&quot; acupuncture method: Patients will recieve the acupuncture treatment,choose the bilateral point:Renying(ST9),Hegu(L14),Taichong(LR3),Quchi(LI11),Zusanli(ST36).&#xD;
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).&#xD;
Drugs: Antihypertensive drugs.Patients will be treated 1 of 5 type of antihypertensive drugs,include ARB、ACEI、βreceptor blocker,CCB,Diuretic.&#xD;
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)</description>
    <arm_group_label>Treatment Group</arm_group_label>
    <other_name>drug</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with the first time ischemic stroke&#xD;
&#xD;
          -  Patients meet the TCM diagnosis standard of Stroke&#xD;
&#xD;
          -  Patients meet the diagnosis standard of hypertension, taking only 1 type of&#xD;
             antihypertensive drugs for at least 2 weeks before admission,corresponding to systolic&#xD;
             pressure ranging from 140 to 160mmHg and Diastolic ranging from 90-100mmHg.&#xD;
&#xD;
          -  The course of Ischemic stroke ranging from 2 weeks to 6 weeks .&#xD;
&#xD;
          -  Men or Women Aged between 35 and 70 years old.&#xD;
&#xD;
          -  Patients who are willing to participate in our clinical trial agree to sign the&#xD;
             informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have been diagnosed with secondary hypertension.&#xD;
&#xD;
          -  Patients have taken beta blockers or diuretics or non dihydropyridine calcium channel&#xD;
             blocker （NDHP-CCB）for a long time because of cardiovascular disease.&#xD;
&#xD;
          -  Patients who taking 1 type of antihypertensive drugs,blood pressure under 140/90mmHg.&#xD;
&#xD;
          -  Patients accompanied with other neurological disorders,such as epilepsy, peripheral&#xD;
             nerve injury,&#xD;
&#xD;
          -  Patients accompanied with severe medical condition such as severe hematopoietic system&#xD;
             disease, coagulation dysfunction and malignant tumor.&#xD;
&#xD;
          -  Patients accompanied with diabetic nephropathy,severe liver and renal&#xD;
             insufficiency,severe cardiac or pulmonary dysfunction,severe arrhythmia.&#xD;
&#xD;
          -  Patients who have occured skin infections near the acupoint location.&#xD;
&#xD;
          -  Pregnant or breast-feeding women.&#xD;
&#xD;
          -  Patients who currently participate in another clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xuemin Shi</last_name>
    <role>Study Director</role>
    <affiliation>The First Teaching Hospital of Tianjin University of TCM</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>yuzheng Du</last_name>
    <phone>13702088266</phone>
    <email>drduyuzheng11@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chongqing Traditional Chinese Medicine Hospital</name>
      <address>
        <city>Chongqing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Zhuxing Wang</last_name>
      <phone>+8613883413646</phone>
      <email>wzhuxing1963@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>MIANYANG Hospital of Traditional Chinese Medicine</name>
      <address>
        <city>Mianyang</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Xiuli Yuan</last_name>
      <phone>+8613881109129</phone>
      <email>13881109129@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>LONGHUA Hospital Shanghai University of Traditional Chinese Medicine</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jian Pei</last_name>
      <phone>+8618917763082</phone>
      <email>jianpei99@yahoo.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shenzhen Bao'an Traditional Chinese Medicine Hospital Group</name>
      <address>
        <city>Shenzhen</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Peng Zhou</last_name>
      <phone>+8613714077462</phone>
      <email>77103698@qq.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>First Teaching Hospital of Tianjin University of TCM</name>
      <address>
        <city>Tianjin</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yuzheng Du</last_name>
      <phone>+8613702088266</phone>
      <email>drduyuzheng11@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 23, 2016</study_first_submitted>
  <study_first_submitted_qc>November 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>July 24, 2017</last_update_submitted>
  <last_update_submitted_qc>July 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>First Teaching Hospital of Tianjin University of Traditional Chinese Medicine</investigator_affiliation>
    <investigator_full_name>Yuzheng Du</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <keyword>Acupuncture</keyword>
  <keyword>Hypertension</keyword>
  <keyword>Second prevention of Stroke</keyword>
  <keyword>Efficacy</keyword>
  <keyword>RCT</keyword>
  <keyword>Study protocol</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebral Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02967484
org study id: 201507001-08
nct id: NCT02967484
lead sponsor: 
collaborator: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: The Effects of Acupuncture on Reccurence of Ischemic Stroke
time frame: 1 year after enrollment
description: 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.
measure: 24-hour ambulatory blood pressure
time frame: the first day、6 weeks、12 weeks after enrollment
measure: Daily Blood Pressure by Electronic Sphygmomanometer
time frame: 1 year after enrollment
measure: Antihypertensive Drug Stop/Resumption/Increasing Rate
time frame: 1 year after enrollment
measure: Nitric Oxide(NO)
time frame: the first day、12 weeks,6 months after enrollment
measure: Endothelin(ET)
time frame: the first day、12 weeks,6 months after enrollment
measure: The Cardiac Color Doppler Ultrasonography
time frame: the first day、12 weeks after enrollment
measure: Carotid Color Ultrasonography
time frame: the first day、12 weeks after enrollment
measure: Brain Color Doppler Ultrasonography
time frame: the first day、12 weeks after enrollment
measure: Lower Extremity Color Ultrasonography
time frame: the first day、12 weeks after enrollment
measure: TCM syndrome score
time frame: the first day、6 weeks、12 weeks after enrollment
measure: Short Form 36-item Health Survey (SF-36)
time frame: the first day、6 weeks、12 weeks after enrollment
measure: National Institute of Health stroke scale (NIHSS)，as well as Barthel Index (BI) scale
time frame: the first day、12 weeks after enrollment
measure: Essen stroke risk score (ESRS)
time frame: the first day、1 year after enrollment
measure: All-caused Morality
time frame: 1 year after enrollment
measure: Serum homocysteine（Hcy）
time frame: the first day、12 weeks,6 months after enrollment
measure: Soluble CD40L（sCD40L）
time frame: the first day、12 weeks,6 months after enrollment
measure: Copeptin
time frame: the first day、12 weeks,6 months after enrollment
arm group label: Treatment Group
arm group type: Experimental
description: 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)
arm group label: Control Group
arm group type: No Intervention
description: 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)
intervention type: Device
intervention name: acupuncture
description: "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)
arm group label: Treatment Group
other name: drug
criteria: 
gender: All
minimum age: 35 Years
maximum age: 75 Years
healthy volunteers: No
last name: Xuemin Shi
role: Study Director
affiliation: The First Teaching Hospital of Tianjin University of TCM
last name: yuzheng Du
phone: 13702088266
email: drduyuzheng11@163.com
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
investigator full name: Yuzheng Du
investigator title: Director
mesh term: Cerebral Infarction
mesh term: Infarction