Intracranial HemorrhagesNCT06243237
Efficacy of Acupuncture in Patients With Acute Intracranial Hemorrhage
A study testing Acupuncture in people with Intracranial Hemorrhages, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Investigators propose a research design protocol to evaluate the efficacy of acupuncture in improving function recovery after acute intracranial hemorrhage. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Intracranial Hemorrhages
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Mar 2024to Nov 2025
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of hemorrhagic stroke by a specialist
- Age over 20 years and below 85 years
- GCS between 5-13
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang-Gung Memorial Hospital
Keelung
Yan Ru Ko
About this study
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
- Conditions
- Intracranial Hemorrhages
- Being tested
- Acupuncture, Sham Acupuncture(Superficial Acupuncture)
- Medical subject headings
- Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
Applied acupuncture on specific acupoints in patient with acute intracranial hemorrhage.
Sham Acupuncture(Superficial Acupuncture)Procedure or surgery
Applied superficial acupuncture on specific acupoints in patient with acute intracranial hemorrhage.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group(acupuncture group) | Experimental | After blind random allocation, investigators applied acupuncture on patient with acute intracranial hemorrhage. Receives: Procedure: Acupuncture |
| Control group(sham acupuncture group (superficial acupuncture)) | Placebo comparator | After blind random allocation, investigators applied superficial acupuncture on patient with acute intracranial hemorrhage. Receives: Procedure: Sham Acupuncture(Superficial Acupuncture) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks and follow-up for one year
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.
Measured: 3 weeks and follow-up for one year
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.
Measured: 3 weeks and follow-up for one year
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.
Measured: 3 weeks and follow-up for one year
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.
Measured: 3 weeks and follow-up for one year
Karnofsky Performance Scale
The Karnofsky Performance Score (KPS) ranking runs from 100 to 0, where 100 is "perfect" health and 0 is death.
Measured: 3 weeks and follow-up for one year
Secondary outcomes (9)
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).
Measured: 3 weeks and follow-up for one year
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.
Measured: 3 weeks and follow-up for one year
White blood cells differential count
Calculating the percentage of each type of white blood cell (WBC): Segment(%), Band(%), Lymphocyte(%), Monocyte(%), Eosinophil(%), Basophil(%)
Measured: 3 weeks and follow-up for one year
C reactive protein (CRP)
Measuring the level of C reactive protein in blood. (CRP, mg/L)
Measured: 3 weeks and follow-up for one year
Albumin
Measuring the level of albumin in blood. (Alb, g/dL)
Measured: 3 weeks and follow-up for one year
Blood urea nitrogen (BUN)
Measuring the level of blood urea nitrogen. (BUN, mg/dL)
Measured: 3 weeks and follow-up for one year
Creatinine
Measuring the level of creatinine in blood. (Crea, mg/dL)
Measured: 3 weeks and follow-up for one year
Sodium
Measuring the level of sodium in blood. (Na, milliequivalent (mEq)/L)
Measured: 3 weeks and follow-up for one year
Potassium
Measuring the level of potassium in blood. (K, milliequivalent (mEq)/L)
Measured: 3 weeks and follow-up for one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start5 Mar 2024
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial HemorrhagesStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Ru Ko, Study director, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06243237
- Sponsor's protocol ID
- 202201836A3
- Status last verified
- Dec 2023
- First submitted
- 19 Dec 2023
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Acupuncture in Patients With Acute Intracranial Hemorrhage
- ClinicalTrials.gov ID
- NCT06243237
- Acronym / sponsor ID
- 202201836A3
- Conditions
- Intracranial Hemorrhages
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 6 Feb 2024 (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.
Investigators propose a research design protocol to evaluate the efficacy of acupuncture in improving function recovery after acute intracranial hemorrhage.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group(acupuncture group) | Experimental | Procedure: AcupunctureAfter blind random allocation, investigators applied acupuncture on patient with acute intracranial hemorrhage. |
| Control group(sham acupuncture group (superficial acupuncture)) | Placebo comparator | Procedure: Sham Acupuncture(Superficial Acupuncture)After blind random allocation, investigators applied superficial acupuncture on patient with acute intracranial hemorrhage. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of hemorrhagic stroke by a specialist
- Age over 20 years and below 85 years
- GCS between 5-13
Key exclusion criteria (5 listed)
- 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)
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 |
|---|---|---|
| AcupunctureApplied acupuncture on specific acupoints in patient with acute intracranial hemorrhage. | Procedure or surgery | Intervention group(acupuncture group) |
| Sham Acupuncture(Superficial Acupuncture)Applied superficial acupuncture on specific acupoints in patient with acute intracranial hemorrhage. | Procedure or surgery | Control group(sham acupuncture group (superficial acupuncture)) |
Primary outcome
Barthel Index
Time frame: 3 weeks and follow-up for one year
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.
Muscle Power
Time frame: 3 weeks and follow-up for one year
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.
The Modified Rankin Scale
Time frame: 3 weeks and follow-up for one year
The Modified Rankin Score (mRS) is a scale with scores ranging from 0 to 6, the higher scores mean the worse outcome.
National Institute of Health Stroke Scale
Time frame: 3 weeks and follow-up for one year
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.
Glasgow Coma Scale(GCS)
Time frame: 3 weeks and follow-up for one year
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.
Karnofsky Performance Scale
Time frame: 3 weeks and follow-up for one year
The Karnofsky Performance Score (KPS) ranking runs from 100 to 0, where 100 is "perfect" health and 0 is death.
9 secondary outcomes
Pulse analysis system (PPAS-96)(Sphygmography)
Time frame: 3 weeks and follow-up for one year
Completed blood count (CBC)
Time frame: 3 weeks and follow-up for one year
White blood cells differential count
Time frame: 3 weeks and follow-up for one year
C reactive protein (CRP)
Time frame: 3 weeks and follow-up for one year
Albumin
Time frame: 3 weeks and follow-up for one year
Blood urea nitrogen (BUN)
Time frame: 3 weeks and follow-up for one year
Creatinine
Time frame: 3 weeks and follow-up for one year
Sodium
Time frame: 3 weeks and follow-up for one year
Potassium
Time frame: 3 weeks and follow-up for one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
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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.
Yan Ru Ko study director
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Intracranial Hemorrhages, run by Chang Gung Memorial 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 5 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Ru Ko (886972792003, b9403213@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Barthel Index (time frame: 3 weeks and follow-up for one year). The study lists 6 primary outcomes in all. 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 5 Jun 2024.