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Status unknownNCT06243237Updated Jun 5, 2024

Efficacy of Acupuncture in Patients With Acute Intracranial Hemorrhage

An interventional study of Acupuncture and Sham Acupuncture(Superficial Acupuncture) in Intracranial Hemorrhages, sponsored by Chang Gung Memorial Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-06-05.

Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
20 Years to 85 Years
Sex
All
01

Study summary

Investigators propose a research design protocol to evaluate the efficacy of acupuncture in improving function recovery after acute intracranial hemorrhage.

Read the detailed description

Stroke is a major cause of death and disability. According to the Ministry of Health and Welfare in Taiwan, stroke accounted for 6.8% of all deaths and was the 4th leading cause of death in Taiwan in 2020. Stroke can be divided into acute, subacute, and chronic stages, and the initial severity of stroke affects recovery from sequelae. Therefore, how to effectively improve the sequelae and accelerate the recovery of patients through early interventions is an important issue. This study aimed to investigate the effect of early acupuncture treatment in the acute stage of hemorrhagic stroke. Subjects will be divided into two main groups by random assignment. The intervention group will be treated with traditional acupuncture, while the control group will be treated with pseudo-acupuncture(superficial acupuncture). The treatment frequency was 3 times a week for at least one week. Consciousness, neurological status and disability status were assessed before treatment, at the end of the first week, the second week and the third week, and biomarker were examined before and after treatment

02

Conditions studied

  • Intracranial Hemorrhages
03

In context

Intracranial Hemorrhages

204 studies on the registry are indexed under Intracranial Hemorrhages; 66 are open to participants now.

This study's planned enrollment of 30 is below the median of 100 across 108 interventional studies indexed under Intracranial Hemorrhages.

Browse Intracranial Hemorrhages studies →

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,091 studies on the registry; 237 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of hemorrhagic stroke by a specialist
  • Age over 20 years and below 85 years
  • GCS between 5-13

Exclusion criteria

Exclusion Criteria:

  • Intracranial hemorrhage resulted from vascular anomalies
  • Pregnant patients
  • Intracranial tumor related hemorrhage
  • Other diseases that can cause neurological deficits, such as old cerebrovascular disease, poliomyelitis, cerebral palsy, spinal cord injury
  • Organ damage or terminal illness (heart or kidney failure or malignancy)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Intervention group(acupuncture group)

    After blind random allocation, investigators applied acupuncture on patient with acute intracranial hemorrhage.

    Procedure: Acupuncture

  • Placebo comparator
    Control group(sham acupuncture group (superficial acupuncture))

    After blind random allocation, investigators applied superficial acupuncture on patient with acute intracranial hemorrhage.

    Procedure: Sham Acupuncture(Superficial Acupuncture)

Interventions

  • ProcedureAcupuncture

    Applied acupuncture on specific acupoints in patient with acute intracranial hemorrhage.

  • ProcedureSham Acupuncture(Superficial Acupuncture)

    Applied superficial acupuncture on specific acupoints in patient with acute intracranial hemorrhage.

06

What researchers measure

Primary outcomes

  1. Barthel Index

    The Barthel Index is a scale used to measure performance in activities of daily living (ADL). The total score can range from 0 (complete dependence) to 100 (complete independence), providing a quantitative measure of an individual's functional independence.

    Time frame: 3 weeks and follow-up for one year

  2. Muscle Power

    Muscle power is often assessed using a grading system. The most common is the Medical Research Council (MRC) Scale, which grades muscle strength on a scale from 0 to 5 and the lower scores mean the worse outcome.

    Time frame: 3 weeks and follow-up for one year

  3. The Modified Rankin Scale

    The Modified Rankin Score (mRS) is a scale with scores ranging from 0 to 6, the higher scores mean the worse outcome.

    Time frame: 3 weeks and follow-up for one year

  4. National Institute of Health Stroke Scale

    The total NIHSS score can range from 0 to 42, where a score of 0 means no stroke symptoms, and a higher score indicates a more severe stroke.

    Time frame: 3 weeks and follow-up for one year

  5. Glasgow Coma Scale(GCS)

    The Glasgow Coma Scale(GCS) is a clinical scale used to reliably measure a person's level of consciousness. The total score can range from 3 to 15, and the lower scores mean the worse outcome.

    Time frame: 3 weeks and follow-up for one year

  6. Karnofsky Performance Scale

    The Karnofsky Performance Score (KPS) ranking runs from 100 to 0, where 100 is "perfect" health and 0 is death.

    Time frame: 3 weeks and follow-up for one year

Secondary outcomes

  1. Pulse analysis system (PPAS-96)(Sphygmography)

    Pulse analysis system (PPAS-96) can realize the digitization of pulse wave graphics, establish a pulse wave database (scale unit: Hertz, Hz).

    Time frame: 3 weeks and follow-up for one year

  2. Completed blood count (CBC)

    Measuring the amounts of red blood cells (RBC, million/μL), white blood cells (WBC, 1000/μL), platelets (Plt, 1000/μL), along with the hemoglobin (Hb, g/dL) and hematocrit (Hct, %) values via automated hematology analyzer.

    Time frame: 3 weeks and follow-up for one year

  3. White blood cells differential count

    Calculating the percentage of each type of white blood cell (WBC): Segment(%), Band(%), Lymphocyte(%), Monocyte(%), Eosinophil(%), Basophil(%)

    Time frame: 3 weeks and follow-up for one year

  4. C reactive protein (CRP)

    Measuring the level of C reactive protein in blood. (CRP, mg/L)

    Time frame: 3 weeks and follow-up for one year

  5. Albumin

    Measuring the level of albumin in blood. (Alb, g/dL)

    Time frame: 3 weeks and follow-up for one year

  6. Blood urea nitrogen (BUN)

    Measuring the level of blood urea nitrogen. (BUN, mg/dL)

    Time frame: 3 weeks and follow-up for one year

  7. Creatinine

    Measuring the level of creatinine in blood. (Crea, mg/dL)

    Time frame: 3 weeks and follow-up for one year

  8. Sodium

    Measuring the level of sodium in blood. (Na, milliequivalent (mEq)/L)

    Time frame: 3 weeks and follow-up for one year

  9. Potassium

    Measuring the level of potassium in blood. (K, milliequivalent (mEq)/L)

    Time frame: 3 weeks and follow-up for one year

07

Study locations

1 of 1 sites recruiting
  • Chang-Gung Memorial Hospital
    Keelung, Taiwan
    • Yan Ru Ko · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06243237
Responsible party
Sponsor
First posted
Feb 6, 2024
Start date
Mar 5, 2024
Primary completion
Nov 2025 (estimated)
Completion
Nov 2025 (estimated)
Last update
Jun 5, 2024

Study contacts

Yan Ru Ko
Contact
b9403213@cgmh.org.tw
886972792003
Yan Ru Ko
study director · Chang Gung Memorial Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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