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Acupuncture Intervention to Improve Neurological Function and Anti-inflammatory Effect in Acute Ischemic Stroke (ANAIS)

NCT ID: NCT03097055

Last Updated: 2019-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-30

Study Completion Date

2019-09-30

Brief Summary

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This study will have acupuncture intervention in acute ischemic stroke patients and evaluate the effect in neurological function improving by National Institutes of Health Stroke Scale (NIHSS), Modified Rankin Scale (mRS), Barthel Index, and antiinflammatory actions by biomarkers.

Detailed Description

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Acupuncture Treatment in Stroke is a widely practiced in Taiwan, mainland China, and around the world. The using in stroke group is countless. Numerous clinical trials have been conducted in the medical community to assess efficacy, and the results mostly suggest that acupuncture may be an effective, low side effects adjuvant therapy. Ischemic stroke is also associated with chronic inflammation-related diseases. In recent years, the anti-inflammatory effect of acupuncture was gradually found. So, whether in the basic or in clinical, the investigators can deduce that acupuncture may be helpful for stroke as an adjuvant therapy.

This study evaluates the neurological function of patients with acute stroke by using the widely used National Institutes of Health Stroke Scale (NIHSS), Modified Rankin Scale (mRS) and Barthel Index. Also, the investigators assess the degree of inflammation by biomarkers. Therefore, the purpose of this study is to explore the effect of acupuncture intervention on acute ischemic patients and its relationship in anti-inflammatory actions.

Conditions

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Acute Ischemic Stroke Acupuncture

Keywords

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Stroke Acupuncture antiinflammatory NIHSS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Traditional Acupuncture

Traditional acupoints and traditional "deqi" manipulation

Group Type EXPERIMENTAL

Traditional Acupuncture

Intervention Type PROCEDURE

widely ongoing traditional acupoints in scalp and limbs with traditional "deqi" manipulation, for stroke patient

Minimal Acupuncture

To avoid traditional acupoints and minimal manipulation

Group Type SHAM_COMPARATOR

Minimal Acupuncture

Intervention Type PROCEDURE

non-traditional acupoints in scalp and limbs, with minimal manipulation

Interventions

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Traditional Acupuncture

widely ongoing traditional acupoints in scalp and limbs with traditional "deqi" manipulation, for stroke patient

Intervention Type PROCEDURE

Minimal Acupuncture

non-traditional acupoints in scalp and limbs, with minimal manipulation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Clinically diagnosed acute ischemic stroke
* Initial NIHSS between 4\~20
* Aged 45 \~ 85

Exclusion Criteria

* Hemorrhagic transformation after cerebral infarction, the hemorrhage size estimated to be ≥ 2cm in diameter by brain imaging.
* Any intracranial hemorrhage , except hemorrhagic transformation after cerebral infarction
* Any intracranial operation during acute stage
* Patient using anticoagulants
* Cerebellar infarction
* Special causes of stroke, such as coagulation abnormalities, or arteriovenous malformations
* Epileptic seizures after stroke
* Combined with infection diseases at the time of assessment
* Pregnant or breastfeeding women
* Present mental illness or symptoms and cannot cooperate with the study
* Cannot sign the inform consent
Minimum Eligible Age

45 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China Medical University, Taiwan

OTHER

Sponsor Role lead

Responsible Party

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Tsai Chueh-Yi

Master Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chueh-Yi Tsai, MD

Role: PRINCIPAL_INVESTIGATOR

Nantou Hospital of the Ministry of Health and Welfare, Taiwan; China Medical University, Taiwan

Ching-Liang Hsieh, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

China Medical University, Taiwan

Locations

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Nantou Hospital of the Ministry of Health and Welfare

Nantou City, Nantou County, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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CMUH106-REC1-008

Identifier Type: -

Identifier Source: org_study_id