Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03097055
Recruitment Status : Active, not recruiting
First Posted : March 31, 2017
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
Tsai Chueh-Yi, China Medical University, Taiwan

Tracking Information
First Submitted Date  ICMJE March 21, 2017
First Posted Date  ICMJE March 31, 2017
Last Update Posted Date May 17, 2019
Actual Study Start Date  ICMJE March 30, 2017
Actual Primary Completion Date December 18, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03097055 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2017)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acupuncture Intervention to Improve Neurological Function and Anti-inflammatory Effect in Acute Ischemic Stroke (ANAIS)
Official Title  ICMJE Acupuncture Intervention to Improve Neurological Function and Anti-inflammatory Effect in Patients With Acute Ischemic Stroke (ANAIS)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Ischemic Stroke
  • Acupuncture
Intervention  ICMJE
  • Procedure: Traditional Acupuncture
    widely ongoing traditional acupoints in scalp and limbs with traditional "deqi" manipulation, for stroke patient
  • Procedure: Minimal Acupuncture
    non-traditional acupoints in scalp and limbs, with minimal manipulation
Study Arms  ICMJE
  • Experimental: Traditional Acupuncture
    Traditional acupoints and traditional "deqi" manipulation
    Intervention: Procedure: Traditional Acupuncture
  • Sham Comparator: Minimal Acupuncture
    To avoid traditional acupoints and minimal manipulation
    Intervention: Procedure: Minimal Acupuncture
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 3, 2019)
50
Original Estimated Enrollment  ICMJE
 (submitted: March 30, 2017)
40
Estimated Study Completion Date  ICMJE September 30, 2019
Actual Primary Completion Date December 18, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03097055
Other Study ID Numbers  ICMJE CMUH106-REC1-008
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Tsai Chueh-Yi, China Medical University, Taiwan
Study Sponsor  ICMJE China Medical University, Taiwan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account China Medical University, Taiwan
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP