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

Primary Purpose

Acute Ischemic Stroke, Acupuncture

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Traditional Acupuncture
Minimal Acupuncture
Sponsored by
China Medical University, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring Stroke, Acupuncture, antiinflammatory, NIHSS

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nantou Hospital of the Ministry of Health and Welfare

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Traditional Acupuncture

Minimal Acupuncture

Arm Description

Traditional acupoints and traditional "deqi" manipulation

To avoid traditional acupoints and minimal manipulation

Outcomes

Primary Outcome Measures

National Institutes of Health Stroke Scale (NIHSS)
The NIHSS improving in about a 2-months-period follow up.

Secondary Outcome Measures

modified Rankin Scale (mRS)
The mRS improving in about a 2-months-period follow up.
Barthel Index
The Barthel Index improving in about a 2-months-period follow up.
inflammatory biomarkers
The inflammatory biomarkers changing in about a 2-months-period follow up.

Full Information

First Posted
March 21, 2017
Last Updated
December 8, 2019
Sponsor
China Medical University, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT03097055
Brief Title
Acupuncture Intervention to Improve Neurological Function and Anti-inflammatory Effect in Acute Ischemic Stroke (ANAIS)
Acronym
ANAIS
Official Title
Acupuncture Intervention to Improve Neurological Function and Anti-inflammatory Effect in Patients With Acute Ischemic Stroke (ANAIS)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
March 30, 2017 (Actual)
Primary Completion Date
December 18, 2018 (Actual)
Study Completion Date
September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Medical University, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke, Acupuncture
Keywords
Stroke, Acupuncture, antiinflammatory, NIHSS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traditional Acupuncture
Arm Type
Experimental
Arm Description
Traditional acupoints and traditional "deqi" manipulation
Arm Title
Minimal Acupuncture
Arm Type
Sham Comparator
Arm Description
To avoid traditional acupoints and minimal manipulation
Intervention Type
Procedure
Intervention Name(s)
Traditional Acupuncture
Intervention Description
widely ongoing traditional acupoints in scalp and limbs with traditional "deqi" manipulation, for stroke patient
Intervention Type
Procedure
Intervention Name(s)
Minimal Acupuncture
Intervention Description
non-traditional acupoints in scalp and limbs, with minimal manipulation
Primary Outcome Measure Information:
Title
National Institutes of Health Stroke Scale (NIHSS)
Description
The NIHSS improving in about a 2-months-period follow up.
Time Frame
1.beginning of stroke (within 3 days after onset); 2.after a 4-weeks acupuncture course (within 7 days after last acupuncture); 3. a month later after acupuncture course (about 28±7 days after last acupuncture)
Secondary Outcome Measure Information:
Title
modified Rankin Scale (mRS)
Description
The mRS improving in about a 2-months-period follow up.
Time Frame
1.beginning of stroke (within 3 days after onset); 2.after a 4-weeks acupuncture course (within 7 days after last acupuncture); 3. a month later after acupuncture course (about 28±7 days after last acupuncture)
Title
Barthel Index
Description
The Barthel Index improving in about a 2-months-period follow up.
Time Frame
1.beginning of stroke (within 3 days after onset); 2.after a 4-weeks acupuncture course (within 7 days after last acupuncture); 3. a month later after acupuncture course (about 28±7 days after last acupuncture)
Title
inflammatory biomarkers
Description
The inflammatory biomarkers changing in about a 2-months-period follow up.
Time Frame
1.beginning of stroke (within 3 days after onset); 2.after a 4-weeks acupuncture course (within 7 days after last acupuncture); 3. a month later after acupuncture course (about 28±7 days after last acupuncture)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chueh-Yi Tsai, MD
Organizational Affiliation
Nantou Hospital of the Ministry of Health and Welfare, Taiwan; China Medical University, Taiwan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ching-Liang Hsieh, MD/PhD
Organizational Affiliation
China Medical University, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nantou Hospital of the Ministry of Health and Welfare
City
Nantou City
State/Province
Nantou County
ZIP/Postal Code
540
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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

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