Ischemic StrokeNCT05734976
Electroacupuncture on Modifying Inflammatory Levels of Cytokines and Metabolites in Stroke Patients.
A study testing electroacupuncture in people with Ischemic Stroke and Acute, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
The study will make an association between the diagnosis of traditional Chinese medicine that establishes that the syndrome of blood stagnation generates alteration in blood flow, vascular dysfunction, and damage to the endothelium. This process is like what occurs in a stroke. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Ischemic Stroke, Acute
- What is being tested?
- electroacupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Oct 2022to 29 Nov 2024
- 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of acute ischemic stroke from (ICD10 diagnostic code I63 - I66) First-time ischemic stroke diagnosis: confirmed with scanner (TC) and magnetic resonance (MRI) Stable hemodynamic indices according to safety standards in patients with ischemic stroke.
- The age is between 35 and 80 years old.
Who cannot join
- Hemorrhagic stroke (diagnostic I61 to diagnostic code I61.9) Cancer patients Recent event trauma requiring hospitalization Patients undergoing immunosuppressive therapy. Drug dependence and abuse. Pregnancy or fertility treatment Required pacemakers.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
China Medical University Hospital
Taichung, Taichung North Distrit, 40044
About this study
Official title: Electroacupuncture on Modifying Inflammatory Levels of Cytokines and Metabolites in Stroke Patients
The study will make an association between the diagnosis of traditional Chinese medicine that establishes that the syndrome of blood stagnation generates alteration in blood flow, vascular dysfunction, and damage to the endothelium. This process is like what occurs in a stroke. It will use electroacupuncture to change this chronic inflammatory process, and to know the effects and efficacy of this technique in the regulation and modulation of to treat extensive inflammatory diseases. However, this inflammatory response must be associated with serum cholesterol levels, since they are associated with a stroke between the LDL-C/HDL-C ratio and the prognosis after a stroke.
Read the detailed description
An adequate early standardized diagnosis of ischemic stroke uses different treatment protocols for these patients, depending on their complexity. Therapeutic windows have been associated with better outcomes when reperfusion or recanalization occurs. Someone has shown strongly related clinical outcome in ischemic stroke to the timely revascularization benefit of acupuncture in stroke patients; electroacupuncture intervention on metabolism is associated with effects on the anti-inflammatory mechanism and metabolic modulation, effects of electroacupuncture stimulation at different spinal segmental levels in a rat model of diabetes mellitus, and another vascular effect of electroacupuncture generate the modulation of the elasticity of the blood vessels.
Electroacupuncture (EA) stimulation is commonly applied in the treatment of ischemic stroke in the clinic. The efficacy of EA is associated with the acupuncture points, intensity, intervals, and duration of the intervention of the treatment for stroke.
The inflammatory response might be associated with serum cholesterol levels since they are associated with a stroke between the LDL-c/HDL-c ratio and the prognosis after a stroke. This study evaluates the impact of electroacupuncture as a modifier of total cholesterol, HDL-c, and LDL-c blood levels and its anti-inflammatory effect in patients with cerebrovascular accidents. Measurement of the post-electroacupuncture serum level (total cholesterol, HDL-c, LDL-c, and triglycerides) will provide adequate information on the influence that these risk factors have on blood vessels and vascular endothelium.
- Conditions
- Ischemic Stroke, Acute
- Being tested
- electroacupuncture
- Keywords
- Stroke, Electroacupunture, Cholesterol
- 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.
electroacupunctureDevice
This is the group that receives real electroacupuncture, applied to selected acupuncture points both on the arms and legs, and on the scalp. All procedures were carried out with disposable needles measuring 0.25 mm in diameter (32-gauge) and 44 mm in length.
| Study group | Role | What they receive |
|---|---|---|
| Electro-Acupuncture can modulate the levels of pro-inflammatory metabolites | Experimental | the disproportionate inflammatory response presented by chronic and acute inflammation as is the case in patients with stroke. In addition, the evaluation of the risk factors associated with the presence of metabolites such as cholesterol and fatty acids will provide us with an adequate diagnosis of the influence that these risk factors have on the blood vessels and the vascular endothelium.This is the group that receives real electroacupuncture, applied to selected acupuncture points both on the arms and legs, and on the scalp. All procedures were carried out with disposable needles measuring 0.25 mm in diameter (32-gauge) and 44 mm in length. Receives: Device: electroacupuncture |
| The design and conduct randomized clinical trial using electroacupunture | Sham comparator | efficacy and effectiveness of electroacupuncture in a clinical trial in electroacupuncture: design of control group and treatment group (including sharm acupuncture) and develop in this study the measurements in the patients and perform everything to the highest standards in both treatment procedures and measurement of results. Randomized controlled trail: intervention strategy and implementation.Also called Sham because it does not receive real stimulation from an acupuncture point, it is 1 cm away from the meridian. All procedures were carried out to a depth of 0.5 cm with disposable needles Receives: Device: electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurological examination( clinical signs of stroke)
National Institutes of Health Stroke Scale (NIHSS) score of 0~40. Barthel Index (BI) score of:0~100.The National Visual Analog Scale (VAS) score of: 0~10.
Measured: This assessment can be used before and after the electroacupuncture treatment period (1 week, 2 weeks, 4 weeks) stroke patient's ability and independence to care for themselves
Secondary outcomes (1)
Blood sample: comparable laboratory results:
Total cholesterol,triglycerides,HDL cholesterol,LDL cholesterol.For routine analyses, the extraction time of blood is between 7 and 9:30 a.m. without previous food They are used for the initial measurement of cholesterol levels in the blood and to monitor and compare these levels once the treatment of EA, Sham and the control group has finished (check blood cholesterol levels).
Measured: First blood sample take at the time of admission, second blood sample taken, completed electroacupuncture treatment 2 weeks, and control 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start11 Oct 2022
- Primary completion29 Nov 2024
- Study completion29 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is clinical trial randomized in electroacupuncture: use a control group and treatment group design (included sham acupuncture) Practice mainly based on medical experience and evidence from clinical cases of CMUH. clinical measurements are made; blood tests to evidence treatment results.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Chen Lee, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05734976
- Sponsor's protocol ID
- CMUH111-REC1-132
- Status last verified
- Jun 2026
- First submitted
- 7 Dec 2022
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huzoor-Akbar, Ardlie NG. Platelet activation in haemostasis: role of thrombin and other clotting factors in platelet-collagen interaction. Haemostasis. 1977;6(1):59-71. doi: 10.1159/000214166.
PubMed 870398How J, West D, Edmonds C. Decompression sickness in diving. Singapore Med J. 1976 Jun;17(2):92-7. No abstract available.
PubMed 982095Xu Y, Zhong DY, Liao XQ, Wang XP, Ge JW, Xu WH. Acupuncture against the metabolic risk factors for stroke: A systematic review of systematic reviews. Medicine (Baltimore). 2022 Sep 2;101(35):e30086. doi: 10.1097/MD.0000000000030086.
PubMed 36107536Sekhar LN, Gormley WB, Wright DC. The best treatment for vestibular schwannoma (acoustic neuroma): microsurgery or radiosurgery? Am J Otol. 1996 Jul;17(4):676-82; discussion 683-9. No abstract available.
PubMed 8841720Barua NR, Patel AR, Takita H, Jennings EC. Fibrosarcoma of the mediastinum. J Surg Oncol. 1979;12(1):11-7. doi: 10.1002/jso.2930120103.
PubMed 480950Duan JY. [Anti-inflammatory and immunologic actions of buyang huanwu tang]. Zhong Xi Yi Jie He Za Zhi. 1989 Mar;9(3):164-6, 134. Chinese.
PubMed 2736703Scots lead the way on alcohol. Br Med J (Clin Res Ed). 1985 Mar 30;290(6473):952-3. No abstract available.
PubMed 3919866Lincoln GA. Pituitary control of testicular activity. Br Med Bull. 1979 May;35(2):167-72. doi: 10.1093/oxfordjournals.bmb.a071565. No abstract available.
PubMed 387164Liefshitz B, Parket A, Maya R, Kupiec M. The role of DNA repair genes in recombination between repeated sequences in yeast. Genetics. 1995 Aug;140(4):1199-211. doi: 10.1093/genetics/140.4.1199.
PubMed 7498763Tewari HB, Sethi JS. Chemo-architectonic studies in a submammalian brain. Adenosine triphosphatase and simple esterase in the diencephalon and mesencephalon. Acta Anat (Basel). 1976;95(3):321-48.
PubMed 134619Kikindjanin V. Clinical signifcans of longitudinal determination of immunoglobulin values in infants with acut respiratory diseases. Allerg Immunol (Leipz). 1977;23(4):273-80.
PubMed 147616
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroacupuncture on Modifying Inflammatory Levels of Cytokines and Metabolites in Stroke Patients
- ClinicalTrials.gov ID
- NCT05734976
- Acronym / sponsor ID
- CMUH111-REC1-132
- Conditions
- Ischemic Stroke, Acute
- Keywords
- Stroke, Electroacupunture, Cholesterol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- 29 Nov 2024 (actual)
- Study completion
- 29 Nov 2024 (actual)
- First posted
- 21 Feb 2023 (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.
The study will make an association between the diagnosis of traditional Chinese medicine that establishes that the syndrome of blood stagnation generates alteration in blood flow, vascular dysfunction, and damage to the endothelium. This process is like what occurs in a stroke. It will use electroacupuncture to change this chronic inflammatory process, and to know the effects and efficacy of this technique in the regulation and modulation of to treat extensive inflammatory diseases. However, this inflammatory response must be associated with serum cholesterol levels, since they are associated with a stroke between the LDL-C/HDL-C ratio and the prognosis after a stroke.
Detailed description
An adequate early standardized diagnosis of ischemic stroke uses different treatment protocols for these patients, depending on their complexity. Therapeutic windows have been associated with better outcomes when reperfusion or recanalization occurs. Someone has shown strongly related clinical outcome in ischemic stroke to the timely revascularization benefit of acupuncture in stroke patients; electroacupuncture intervention on metabolism is associated with effects on the anti-inflammatory mechanism and metabolic modulation, effects of electroacupuncture stimulation at different spinal segmental levels in a rat model of diabetes mellitus, and another vascular effect of electroacupuncture generate the modulation of the elasticity of the blood vessels.
Electroacupuncture (EA) stimulation is commonly applied in the treatment of ischemic stroke in the clinic. The efficacy of EA is associated with the acupuncture points, intensity, intervals, and duration of the intervention of the treatment for stroke.
The inflammatory response might be associated with serum cholesterol levels since they are associated with a stroke between the LDL-c/HDL-c ratio and the prognosis after a stroke. This study evaluates the impact of electroacupuncture as a modifier of total cholesterol, HDL-c, and LDL-c blood levels and its anti-inflammatory effect in patients with cerebrovascular accidents. Measurement of the post-electroacupuncture serum level (total cholesterol, HDL-c, LDL-c, and triglycerides) will provide adequate information on the influence that these risk factors have on blood vessels and vascular endothelium.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is clinical trial randomized in electroacupuncture: use a control group and treatment group design (included sham acupuncture) Practice mainly based on medical experience and evidence from clinical cases of CMUH. clinical measurements are made; blood tests to evidence treatment results.
| Arm | Type | Receives |
|---|---|---|
| Electro-Acupuncture can modulate the levels of pro-inflammatory metabolites | Experimental | Device: electroacupuncturethe disproportionate inflammatory response presented by chronic and acute inflammation as is the case in patients with stroke. In addition, the evaluation of the risk factors associated with the presence of metabolites such as cholesterol and fatty acids will provide us with an adequate diagnosis of the influence that these risk factors have on the blood vessels and the vascular endothelium.This is the group that receives real electroacupuncture, applied to selected acupuncture points both on the arms and legs, and on the scalp. All procedures were carried out with disposable needles measuring 0.25 mm in diameter (32-gauge) and 44 mm in length. |
| The design and conduct randomized clinical trial using electroacupunture | Sham comparator | Device: electroacupunctureefficacy and effectiveness of electroacupuncture in a clinical trial in electroacupuncture: design of control group and treatment group (including sharm acupuncture) and develop in this study the measurements in the patients and perform everything to the highest standards in both treatment procedures and measurement of results. Randomized controlled trail: intervention strategy and implementation.Also called Sham because it does not receive real stimulation from an acupuncture point, it is 1 cm away from the meridian. All procedures were carried out to a depth of 0.5 cm with disposable needles |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of acute ischemic stroke from (ICD10 diagnostic code I63 - I66) First-time ischemic stroke diagnosis: confirmed with scanner (TC) and magnetic resonance (MRI) Stable hemodynamic indices according to safety standards in patients with ischemic stroke.
- The age is between 35 and 80 years old.
Key exclusion criteria (1 listed)
- Hemorrhagic stroke (diagnostic I61 to diagnostic code I61.9) Cancer patients Recent event trauma requiring hospitalization Patients undergoing immunosuppressive therapy. Drug dependence and abuse. Pregnancy or fertility treatment Required pacemakers.
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 |
|---|---|---|
| electroacupunctureThis is the group that receives real electroacupuncture, applied to selected acupuncture points both on the arms and legs, and on the scalp. All procedures were carried out with disposable needles measuring 0.25 mm in diameter (32-gauge) and 44 mm in length. | Device | Electro-Acupuncture can modulate the levels of pro-inflammatory metabolites, The design and conduct randomized clinical trial using electroacupunture |
Primary outcome
Neurological examination( clinical signs of stroke)
Time frame: This assessment can be used before and after the electroacupuncture treatment period (1 week, 2 weeks, 4 weeks) stroke patient's ability and independence to care for themselves
National Institutes of Health Stroke Scale (NIHSS) score of 0~40. Barthel Index (BI) score of:0~100.The National Visual Analog Scale (VAS) score of: 0~10.
1 secondary outcome
Blood sample: comparable laboratory results:
Time frame: First blood sample take at the time of admission, second blood sample taken, completed electroacupuncture treatment 2 weeks, and control 4 weeks
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 5 Jun 2026.
- Background: PubMed 870398Huzoor-Akbar, Ardlie NG. Platelet activation in haemostasis: role of thrombin and other clotting factors in platelet-collagen interaction. Haemostasis. 1977;6(1):59-71. doi: 10.1159/000214166.
- Background: PubMed 982095How J, West D, Edmonds C. Decompression sickness in diving. Singapore Med J. 1976 Jun;17(2):92-7. No abstract available.
- Results publication: PubMed 36107536Xu Y, Zhong DY, Liao XQ, Wang XP, Ge JW, Xu WH. Acupuncture against the metabolic risk factors for stroke: A systematic review of systematic reviews. Medicine (Baltimore). 2022 Sep 2;101(35):e30086. doi: 10.1097/MD.0000000000030086.
- Results publication: PubMed 8841720Sekhar LN, Gormley WB, Wright DC. The best treatment for vestibular schwannoma (acoustic neuroma): microsurgery or radiosurgery? Am J Otol. 1996 Jul;17(4):676-82; discussion 683-9. No abstract available.
- Results publication: PubMed 480950Barua NR, Patel AR, Takita H, Jennings EC. Fibrosarcoma of the mediastinum. J Surg Oncol. 1979;12(1):11-7. doi: 10.1002/jso.2930120103.
- Results publication: PubMed 2736703Duan JY. [Anti-inflammatory and immunologic actions of buyang huanwu tang]. Zhong Xi Yi Jie He Za Zhi. 1989 Mar;9(3):164-6, 134. Chinese.
- Results publication: PubMed 3919866Scots lead the way on alcohol. Br Med J (Clin Res Ed). 1985 Mar 30;290(6473):952-3. No abstract available.
- Results publication: PubMed 387164Lincoln GA. Pituitary control of testicular activity. Br Med Bull. 1979 May;35(2):167-72. doi: 10.1093/oxfordjournals.bmb.a071565. No abstract available.
- Results publication: PubMed 7498763Liefshitz B, Parket A, Maya R, Kupiec M. The role of DNA repair genes in recombination between repeated sequences in yeast. Genetics. 1995 Aug;140(4):1199-211. doi: 10.1093/genetics/140.4.1199.
- Results publication: PubMed 134619Tewari HB, Sethi JS. Chemo-architectonic studies in a submammalian brain. Adenosine triphosphatase and simple esterase in the diencephalon and mesencephalon. Acta Anat (Basel). 1976;95(3):321-48.
- Results publication: PubMed 147616Kikindjanin V. Clinical signifcans of longitudinal determination of immunoglobulin values in infants with acut respiratory diseases. Allerg Immunol (Leipz). 1977;23(4):273-80.
- Stroke: Morbidity, Risk Factors, and Care in TaiwanLink provided by the sponsor.
- Pathophysiology of Lacunar Stroke: History's Mysteries and Modern InterpretationsLink provided by the sponsor.
- Follow-up study on serum cholesterol profiles and potential sequelae in recovered COVID-19 patientsLink provided by the sponsor.
- An evaluation of lipid profle and pro-infammatory cytokines as determinants of cardiovascular disease in those with diabetes: a study on a Mexican American cohortLink provided by the sponsor.
- Correlation between Serum Lipid Parameters and Interleukin-10 Concentration in Obese IndividualsLink provided by the sponsor.
- COVID-19-activated SREBP2 disturbs cholesterol biosynthesis and leads to cytokine stormLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electroacupuncture in people with Ischemic Stroke and Acute, run by China Medical University Hospital 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 2 inclusion and 1 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 5 Jun 2026. 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?
Neurological examination( clinical signs of stroke) (time frame: This assessment can be used before and after the electroacupuncture treatment period (1 week, 2 weeks, 4 weeks) stroke patient's ability and independence to care for themselves). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05734976, which also lists 11 linked publications.
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 5 Jun 2026.