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Trial record 61 of 1171 for:    acupuncture

Acupuncture Lowering Blood Pressure for Secondary Prevention of Stroke

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ClinicalTrials.gov Identifier: NCT02967484
Recruitment Status : Recruiting
First Posted : November 18, 2016
Last Update Posted : July 26, 2017
Sponsor:
Collaborator:
State Administration of Traditional Chinese Medicine of the People's Republic of China
Information provided by (Responsible Party):
Yuzheng Du, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

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.

Condition or disease Intervention/treatment Phase
Cerebral Infarction Device: acupuncture Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Acupuncture Lowering Blood Pressure for Secondary Prevention of Stroke: Study Protocol for a Multicenter, Pragmatic,Randomized Controlled, Assessor-blinded Clinical Trial
Actual Study Start Date : November 20, 2016
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


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 Name: 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)




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


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02967484


Contacts
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Contact: yuzheng Du 13702088266 drduyuzheng11@163.com

Locations
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China
Chongqing Traditional Chinese Medicine Hospital Not yet recruiting
Chongqing, China
Contact: Zhuxing Wang    +8613883413646    wzhuxing1963@163.com   
MIANYANG Hospital of Traditional Chinese Medicine Not yet recruiting
Mianyang, China
Contact: Xiuli Yuan    +8613881109129    13881109129@163.com   
LONGHUA Hospital Shanghai University of Traditional Chinese Medicine Not yet recruiting
Shanghai, China
Contact: Jian Pei    +8618917763082    jianpei99@yahoo.com   
Shenzhen Bao'an Traditional Chinese Medicine Hospital Group Not yet recruiting
Shenzhen, China
Contact: Peng Zhou    +8613714077462    77103698@qq.com   
First Teaching Hospital of Tianjin University of TCM Recruiting
Tianjin, China
Contact: Yuzheng Du    +8613702088266    drduyuzheng11@163.com   
Sponsors and Collaborators
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
State Administration of Traditional Chinese Medicine of the People's Republic of China
Investigators
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Study Director: Xuemin Shi The First Teaching Hospital of Tianjin University of TCM

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yuzheng Du, Director, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT02967484     History of Changes
Other Study ID Numbers: 201507001-08
First Posted: November 18, 2016    Key Record Dates
Last Update Posted: July 26, 2017
Last Verified: July 2017

Keywords provided by Yuzheng Du, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine:
Acupuncture
Hypertension
Second prevention of Stroke
Efficacy
RCT
Study protocol

Additional relevant MeSH terms:
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Infarction
Cerebral Infarction
Ischemia
Pathologic Processes
Necrosis
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Stroke
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents