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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05731310
Other study ID # 2022-0507
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date August 1, 2022
Est. completion date July 31, 2024

Study information

Verified date February 2023
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact le zhang
Phone 86-13616511229
Email 2319053@zju.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 65
Est. completion date July 31, 2024
Est. primary completion date July 31, 2024
Accepts healthy volunteers No
Gender All
Age group 40 Years to 70 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
China 2nd Affiliated Hospital, School of Medicine Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Simple intelligence state examination scale MMSE up to 4 weeks
See also
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Not yet recruiting NCT06316557 - High-frequency rTMS on the Cerebellar to Improve Post-stroke Cognitive Impairment N/A