Efficacy of Acupuncture in Patients With Acute Intracranial Hemorrhage

Intracranial Hemorrhages Clinical Trial

Official title:

Efficacy of Acupuncture in Patients With Acute Intracranial Hemorrhage

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06243237
• Other study ID #: 202201836A3
• Status: Recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: November 2025

Study information

• Verified date: December 2023
• Source: Chang Gung Memorial Hospital
• Contact: Yan Ru Ko
• Phone: 886972792003
• Email: b9403213[@]cgmh.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

Inclusion Criteria:

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

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)

Related Conditions & MeSH terms

• Hemorrhage
• Intracranial Hemorrhages

Intervention

Procedure:
• Acupuncture
Applied acupuncture on specific acupoints in patient with acute intracranial hemorrhage.
• Sham Acupuncture(Superficial Acupuncture)
Applied superficial acupuncture on specific acupoints in patient with acute intracranial hemorrhage.

Locations

Country	Name	City	State
Taiwan	Chang-Gung Memorial Hospital	Keelung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 weeks and follow-up for one year
Primary	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.	3 weeks and follow-up for one year
Primary	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.	3 weeks and follow-up for one year
Primary	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.	3 weeks and follow-up for one year
Primary	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.	3 weeks and follow-up for one year
Primary	Karnofsky Performance Scale	The Karnofsky Performance Score (KPS) ranking runs from 100 to 0, where 100 is "perfect" health and 0 is death.	3 weeks and follow-up for one year
Secondary	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).	3 weeks and follow-up for one year
Secondary	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.	3 weeks and follow-up for one year
Secondary	White blood cells differential count	Calculating the percentage of each type of white blood cell (WBC): Segment(%), Band(%), Lymphocyte(%), Monocyte(%), Eosinophil(%), Basophil(%)	3 weeks and follow-up for one year
Secondary	C reactive protein (CRP)	Measuring the level of C reactive protein in blood. (CRP, mg/L)	3 weeks and follow-up for one year
Secondary	Albumin	Measuring the level of albumin in blood. (Alb, g/dL)	3 weeks and follow-up for one year
Secondary	Blood urea nitrogen (BUN)	Measuring the level of blood urea nitrogen. (BUN, mg/dL)	3 weeks and follow-up for one year
Secondary	Creatinine	Measuring the level of creatinine in blood. (Crea, mg/dL)	3 weeks and follow-up for one year
Secondary	Sodium	Measuring the level of sodium in blood. (Na, milliequivalent (mEq)/L)	3 weeks and follow-up for one year
Secondary	Potassium	Measuring the level of potassium in blood. (K, milliequivalent (mEq)/L)	3 weeks and follow-up for one year