Efficacy of Acupuncture in Patients With Acute Intracranial Hemorrhage

NCT ID: NCT06243237

Last Updated: 2024-06-05

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

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-05

Study Completion Date

2025-11-30

Brief Summary

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

Detailed Description

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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

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Intracranial Hemorrhages

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Intervention group(acupuncture group)

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

Group Type EXPERIMENTAL

Acupuncture

Intervention Type PROCEDURE

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

Control group(sham acupuncture group (superficial acupuncture))

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

Group Type PLACEBO_COMPARATOR

Sham Acupuncture(Superficial Acupuncture)

Intervention Type PROCEDURE

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

Interventions

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Acupuncture

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

Intervention Type PROCEDURE

Sham Acupuncture(Superficial Acupuncture)

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

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yan Ru Ko

Role: STUDY_DIRECTOR

Chang Gung Memorial Hospital

Locations

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Chang-Gung Memorial Hospital

Keelung, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yan Ru Ko

Role: CONTACT

886972792003

Facility Contacts

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Yan Ru Ko

Role: primary

Other Identifiers

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202201836A3

Identifier Type: -

Identifier Source: org_study_id

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