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

December 8, 2019 updated by: Tsai Chueh-Yi, China Medical University, Taiwan

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Nantou County
      • Nantou City, Nantou County, Taiwan, 540
        • Nantou Hospital of the Ministry of Health and Welfare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Traditional Acupuncture
Traditional acupoints and traditional "deqi" manipulation
Procedure: Traditional Acupuncture
widely ongoing traditional acupoints in scalp and limbs with traditional "deqi" manipulation, for stroke patient
Sham Comparator: Minimal Acupuncture
To avoid traditional acupoints and minimal manipulation
Procedure: Minimal Acupuncture
non-traditional acupoints in scalp and limbs, with minimal manipulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
National Institutes of Health Stroke Scale (NIHSS)
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)
The NIHSS improving in about a 2-months-period follow up.
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 Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University, Taiwan

Investigators

  • Principal Investigator: Chueh-Yi Tsai, MD, Nantou Hospital of the Ministry of Health and Welfare, Taiwan; China Medical University, Taiwan
  • Principal Investigator: Ching-Liang Hsieh, MD/PhD, China Medical University, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2017

Primary Completion (Actual)

December 18, 2018

Study Completion (Actual)

September 30, 2019

Study Registration Dates

First Submitted

March 21, 2017

First Submitted That Met QC Criteria

March 30, 2017

First Posted (Actual)

March 31, 2017

Study Record Updates

Last Update Posted (Actual)

December 10, 2019

Last Update Submitted That Met QC Criteria

December 8, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMUH106-REC1-008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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