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

February 7, 2023 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

65

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • 2nd Affiliated Hospital, School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Angong Niuhuang Pill Group
Take half an Angong Niuhuang pill every day for 4 weeks
Drug: 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
Other Names:
  • Angong Niuhuang pill combined with music scalp acupuncture group
Experimental: 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
Drug: 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
Other Names:
  • Angong Niuhuang pill combined with music scalp acupuncture group
No Intervention: General control group
no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Simple intelligence state examination scale
Time Frame: up to 4 weeks
MMSE
up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

  • Study Chair: le zhang, 2nd Affiliated Hospital, School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Anticipated)

July 31, 2024

Study Completion (Anticipated)

July 31, 2024

Study Registration Dates

First Submitted

February 7, 2023

First Submitted That Met QC Criteria

February 7, 2023

First Posted (Estimate)

February 16, 2023

Study Record Updates

Last Update Posted (Estimate)

February 16, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-0507

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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