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Clinical Trials/NCT05731310
NCT05731310RecruitingEarly Phase 1

Efficacy Evaluation and Evaluation of Peripheral Neuroprotective Mechanism of Amgong Niuhuang Pill Combined With Supervised Pulse Music Electroacupuncture on Cognitive Impairment After Ischemic Stroke

Second Affiliated Hospital, School of Medicine, Zhejiang University1 site in 1 country65 target enrollmentStarted: August 1, 2022Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Early Phase 1
Status
Recruiting
Sponsor
Enrollment
65
Locations
1
Primary Endpoint
Simple intelligence state examination scale

Study Overview

Brief Summary

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

(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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
40 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Angong Niuhuang Pill Group

Experimental

Take half an Angong Niuhuang pill every day for 4 weeks

Intervention: Angong Niuhuang Pill (Drug)

Angong Niuhuang pill combined with music electroacupuncture group

Experimental

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

Intervention: Angong Niuhuang Pill (Drug)

Outcomes

Primary Outcomes

Simple intelligence state examination scale

Time Frame: up to 4 weeks

MMSE

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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