NCT02967484

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
480

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 18, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

November 20, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

July 26, 2017

Status Verified

July 1, 2017

Enrollment Period

3.4 years

First QC Date

July 23, 2016

Last Update Submit

July 24, 2017

Conditions

Cerebral Infarction

Keywords

AcupunctureHypertensionSecond prevention of StrokeEfficacyRCTStudy protocol

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (17)

  • 24-hour ambulatory blood pressure

    the first day、6 weeks、12 weeks after enrollment

  • Daily Blood Pressure by Electronic Sphygmomanometer

    1 year after enrollment

  • Antihypertensive Drug Stop/Resumption/Increasing Rate

    1 year after enrollment

  • Nitric Oxide(NO)

    the first day、12 weeks,6 months after enrollment

  • Endothelin(ET)

    the first day、12 weeks,6 months after enrollment

  • +12 more secondary outcomes

Study Arms (2)

Treatment Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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)

Interventions

acupunctureDEVICE

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)

Also known as: drug
Treatment Group

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Chongqing Traditional Chinese Medicine Hospital

Chongqing, China

NOT YET RECRUITING

MIANYANG Hospital of Traditional Chinese Medicine

Mianyang, China

NOT YET RECRUITING

LONGHUA Hospital Shanghai University of Traditional Chinese Medicine

Shanghai, China

NOT YET RECRUITING

Shenzhen Bao'an Traditional Chinese Medicine Hospital Group

Shenzhen, China

NOT YET RECRUITING

First Teaching Hospital of Tianjin University of TCM

Tianjin, China

RECRUITING

Related Publications (1)

  • Du YZ, Gao XX, Wang CT, Zheng HZ, Lei Y, Wu MH, Shi XM, Ban HP, Gu WL, Meng XG, Wei MT, Hu CX. Acupuncture lowering blood pressure for secondary prevention of stroke: a study protocol for a multicenter randomized controlled trial. Trials. 2017 Sep 15;18(1):428. doi: 10.1186/s13063-017-2171-5.

    PMID: 28915826DERIVED

MeSH Terms

Conditions

Cerebral InfarctionHypertension

Interventions

Acupuncture TherapyDosage Forms

Condition Hierarchy (Ancestors)

Brain InfarctionBrain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesStrokeVascular DiseasesCardiovascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPharmaceutical PreparationsTechnology, PharmaceuticalInvestigative Techniques

Study Officials

  • Xuemin Shi

    The First Teaching Hospital of Tianjin University of TCM

    STUDY DIRECTOR

Central Study Contacts

yuzheng Du

CONTACT

13702088266drduyuzheng11@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

July 23, 2016

First Posted

November 18, 2016

Study Start

November 20, 2016

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

July 26, 2017

Record last verified: 2017-07

Locations

CN(5)