Acute Ischemic StrokeANAISNCT03097055
Acupuncture Intervention to Improve Neurological Function and Anti-inflammatory Effect in Acute Ischemic Stroke (ANAIS)
A study testing Traditional Acupuncture and Minimal Acupuncture in people with Acute Ischemic Stroke and Acupuncture, run by China Medical University, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Acute Ischemic Stroke, Acupuncture
- What is being tested?
- Traditional Acupuncture and Minimal Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Mar 2017to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically diagnosed acute ischemic stroke
- Initial NIHSS between 4~20
- Aged 45 ~ 85
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Nantou Hospital of the Ministry of Health and Welfare
Nantou City, Nantou County, 540
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Ischemic Stroke, Acupuncture
- Being tested
- Traditional Acupuncture, Minimal Acupuncture
- Keywords
- Stroke, Acupuncture, antiinflammatory, NIHSS
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional AcupunctureProcedure or surgery
widely ongoing traditional acupoints in scalp and limbs with traditional "deqi" manipulation, for stroke patient
Minimal AcupunctureProcedure or surgery
non-traditional acupoints in scalp and limbs, with minimal manipulation
| Study group | Role | What they receive |
|---|---|---|
| Traditional Acupuncture | Experimental | Traditional acupoints and traditional "deqi" manipulation Receives: Procedure: Traditional Acupuncture |
| Minimal Acupuncture | Sham comparator | To avoid traditional acupoints and minimal manipulation Receives: Procedure: Minimal Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
National Institutes of Health Stroke Scale (NIHSS)
The NIHSS improving in about a 2-months-period follow up.
Measured: 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 outcomes (3)
modified Rankin Scale (mRS)
The mRS improving in about a 2-months-period follow up.
Measured: 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
The Barthel Index improving in about a 2-months-period follow up.
Measured: 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
The inflammatory biomarkers changing in about a 2-months-period follow up.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study start30 Mar 2017
- Primary completion18 Dec 2018
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tsai Chueh-Yi, China Medical University, Taiwan
- Investigators
- Chueh-Yi Tsai, MD, Principal investigator, Nantou Hospital of the Ministry of Health and Welfare, Taiwan; China Medical University, TaiwanChing-Liang Hsieh, MD/PhD, Principal investigator, China Medical University, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03097055
- Sponsor's protocol ID
- CMUH106-REC1-008
- Acronym
- ANAIS
- Status last verified
- Dec 2019
- First submitted
- 21 Mar 2017
- Last updated
- 10 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture Intervention to Improve Neurological Function and Anti-inflammatory Effect in Patients With Acute Ischemic Stroke (ANAIS)
- ClinicalTrials.gov ID
- NCT03097055
- Acronym / sponsor ID
- ANAIS / CMUH106-REC1-008
- Conditions
- Acute Ischemic Stroke, Acupuncture
- Keywords
- Stroke, Acupuncture, antiinflammatory, NIHSS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- China Medical University, TaiwanUniversity, hospital or other
- Study start
- 30 Mar 2017 (actual)
- Primary completion
- 18 Dec 2018 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 31 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Acupuncture | Experimental | Procedure: Traditional AcupunctureTraditional acupoints and traditional "deqi" manipulation |
| Minimal Acupuncture | Sham comparator | Procedure: Minimal AcupunctureTo avoid traditional acupoints and minimal manipulation |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinically diagnosed acute ischemic stroke
- Initial NIHSS between 4~20
- Aged 45 ~ 85
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional Acupuncturewidely ongoing traditional acupoints in scalp and limbs with traditional "deqi" manipulation, for stroke patient | Procedure or surgery | Traditional Acupuncture |
| Minimal Acupuncturenon-traditional acupoints in scalp and limbs, with minimal manipulation | Procedure or surgery | Minimal Acupuncture |
Primary outcome
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.
3 secondary outcomes
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2019.
- Individual participant dataSharing planned: No
Related trials for Acute Ischemic Stroke
Not yet recruitingPhase 3
Upfront Lipid-Lowering Therapy With Statins Combined With Hybutimibe in Patients With Acute Ischemic Stroke or Transient Ischemic Attack.
Ischemia Stroke, TIA (Transient Ischemic Attack)
Not yet recruitingPhase 3
INTRA-ARTERIAL MeVO TREATMENT (IMP-ACT) Within the ACT-GLOBAL Adaptive Platform Trial-NCT06352632
Stroke, Acute Ischemic, Medium Vessel Occlusion
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chueh-Yi Tsai, MD principal investigator
Nantou Hospital of the Ministry of Health and Welfare, Taiwan; China Medical University, Taiwan
Ching-Liang Hsieh, MD/PhD principal investigator
China Medical University, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Acupuncture and Minimal Acupuncture in people with Acute Ischemic Stroke and Acupuncture, run by China Medical University, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2019.