Electroacupuncture on Modifying Inflammatory Levels of Cytokines and Metabolites in Stroke Patients.

NCT ID: NCT05734976

Last Updated: 2023-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-14

Study Completion Date

2023-09-13

Brief Summary

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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

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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

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Ischemic Stroke Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is clinical trialrandomized in electroacupuncture: use a control group and treatment group design(included sharm acupuncture) Practice mainly based on medical experience and evidence from clinical cases of CMUH.clinical measurements are made; blood tests to evidence treatment results.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators
The measure in this study is the change in Visual Analog Scale (VAS), National Institutes of Health Stroke Scale (NIHSS), Barthel Index (BI), after completing 2 weeks of electroacupuncture. Clinical measurements are made; blood tests to show the results of the treatment

Study Groups

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Electro-Acupuncture can modulate the levels of pro-inflammatory metabolites

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.

Group Type EXPERIMENTAL

electroacupuncture

Intervention Type DEVICE

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

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

Group Type SHAM_COMPARATOR

electroacupuncture

Intervention Type DEVICE

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.

Arm type Methodological challenge in design

Electroacupuncture treatment, develops different groups study are three; electroacupuncture group or real treatment,1st control group or Participants in the sham group also received 24 sessions of acupuncture treatment; however, needling was performed 1 cm away from the real acupoints and 2nd control group or non-penetration needles. Access to medical records; to collect data and store it securely and anonymously.this group will receive treatment at 6 acupuncture points, but without penetration, without electroacupuncture, this is why it is called the control group. Use disposable needles too

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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electroacupuncture

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Clinical diagnosis of patients with acute ischemic stroke
2. Stroke diagnosed for the first time
3. Must be able to respond to simple commands and tolerate the electroacupuncture

Exclusion Criteria

1. Malignant cancer diagnosis
2. Traumatic event
3. Immunosuppressive patients
4. Drug abuse
5. Pregnant or lactating women
6. Cardiac pacemaker patient
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yu-Chen Lee

Chief and Attending Physician, Department of Acupuncture, China Medical University Hospital, Taichung, Taiwan.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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China Medical University Hospital

Taichung, Taichung North Distrit, Taiwan

Site Status

Countries

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Taiwan

References

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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.

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Reference Type BACKGROUND
PMID: 982095 (View on PubMed)

Xu 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.

Reference Type RESULT
PMID: 36107536 (View on PubMed)

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Reference Type RESULT
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Reference Type RESULT
PMID: 480950 (View on PubMed)

Duan 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.

Reference Type RESULT
PMID: 2736703 (View on PubMed)

Scots lead the way on alcohol. Br Med J (Clin Res Ed). 1985 Mar 30;290(6473):952-3. No abstract available.

Reference Type RESULT
PMID: 3919866 (View on PubMed)

Lincoln GA. Pituitary control of testicular activity. Br Med Bull. 1979 May;35(2):167-72. doi: 10.1093/oxfordjournals.bmb.a071565. No abstract available.

Reference Type RESULT
PMID: 387164 (View on PubMed)

Liefshitz 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.

Reference Type RESULT
PMID: 7498763 (View on PubMed)

Tewari 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.

Reference Type RESULT
PMID: 134619 (View on PubMed)

Kikindjanin V. Clinical signifcans of longitudinal determination of immunoglobulin values in infants with acut respiratory diseases. Allerg Immunol (Leipz). 1977;23(4):273-80.

Reference Type RESULT
PMID: 147616 (View on PubMed)

Related Links

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http://doi.org/10.5853/jos.2014.16.2.59

Stroke: Morbidity, Risk Factors, and Care in Taiwan

http://doi.org/10.1016/j.jstrokecerebrovasdis.2019.05.006

Pathophysiology of Lacunar Stroke: History's Mysteries and Modern Interpretations

http://doi.org/10.1186/s12879-021-05984-1

Follow-up study on serum cholesterol profiles and potential sequelae in recovered COVID-19 patients

http://doi.org/10.1038/s41598-021-81730-6

An evaluation of lipid profle and pro-infammatory cytokines as determinants of cardiovascular disease in those with diabetes: a study on a Mexican American cohort

http://doi.org/10.7570/jomes20122

Correlation between Serum Lipid Parameters and Interleukin-10 Concentration in Obese Individuals

http://doi.org/10.1038/s41392-020-00292-7

COVID-19-activated SREBP2 disturbs cholesterol biosynthesis and leads to cytokine storm

Other Identifiers

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CMUH111-REC1-132

Identifier Type: -

Identifier Source: org_study_id

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