Clinical Study of Angong Niuhuang Pill and Acupuncture on PSCI Angong Niuhuang Pill Combined With Supervised Pulse Music Electroacupuncture on Cognitive Impairment After Ischemic Stroke

NCT ID: NCT05731310

Last Updated: 2023-02-16

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

EARLY_PHASE1

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2024-07-31

Brief Summary

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Post stroke cognitive impairment (PSCI) refers to the attainment of cognitive impairment after the clinical event of stroke A range of syndromes that impede diagnostic criteria. Epidemiologically, PSCI is one of the common complications in stroke patients

Detailed Description

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(1) Clinical scale data of cognitive function, daily living ability of PSCI patients integrated with the research of this project using uterine Niu Huang pill combined with examined pulse music electroacupuncture

For analysis, the efficacy of PSCI patients was observed; (2) In depth studies on auditory event-related potentials of PSCI treated by uterine Niu Huang pill combined with examined pulse music electroacupuncture

The changes of serum related nerve growth factor and the relationship between each other in order to enrich / fill our province's research results in this field; (3) In key academic journals

1 high level scientific research paper published.

Conditions

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Post-stroke Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Angong Niuhuang Pill Group

Take half an Angong Niuhuang pill every day for 4 weeks

Group Type EXPERIMENTAL

Angong Niuhuang Pill

Intervention Type DRUG

Take Angong Niuhuang pill half a pill/day; Angong Niuhuang pill combined with music scalp acupuncture group These operations last for 4 weeks

Angong Niuhuang pill combined with music electroacupuncture group

Take half an Angong Niuhuang pill every day for 4 weeks and Daily music scalp acupuncture treatment

Group Type EXPERIMENTAL

Angong Niuhuang Pill

Intervention Type DRUG

Take Angong Niuhuang pill half a pill/day; Angong Niuhuang pill combined with music scalp acupuncture group These operations last for 4 weeks

General control group

no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Angong Niuhuang Pill

Take Angong Niuhuang pill half a pill/day; Angong Niuhuang pill combined with music scalp acupuncture group These operations last for 4 weeks

Intervention Type DRUG

Other Intervention Names

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Angong Niuhuang pill combined with music scalp acupuncture group

Eligibility Criteria

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Inclusion Criteria

(1) All were the first stroke, confirmed by head computed tomography (CT) or magnetic resonance imaging (MRI), with vital signs

stable; (2) Those who are conscious and can cooperate with relevant treatment; (3) Montreal Cognitive Assessment Scale (MoCA) score ≤ 24 points; (4)

The course of disease is more than 1 month, and the patient is 40-70 years old.

Exclusion Criteria

(1) People with cognitive impairment before onset; (2) There are contraindications of Angong Niuhuang Pill or electroacupuncture treatment;

(3) Complicated with dysfunction of heart, liver, kidney and other important organs; (4) Previous history of cerebral hemorrhage, epilepsy, brain injury, etc; (5) Before onset

Have a history of alcohol and drug dependence; (6) The condition worsens, and new hemorrhagic or infarcted foci appear.

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Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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le zhang

Role: STUDY_CHAIR

2nd Affiliated Hospital, School of Medicine

Locations

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2nd Affiliated Hospital, School of Medicine

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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le zhang

Role: CONTACT

86-13616511229

Facility Contacts

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le zhang

Role: primary

86-13616511229

Other Identifiers

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2022-0507

Identifier Type: -

Identifier Source: org_study_id

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