Back to resultsClinical Study of Angong Niuhuang Pill and Acupuncture on PSCI Angong Niuhuang Pill Combined With Supervised Pulse Music Electroacupuncture on Cognitive Impairment After Ischemic Stroke
Primary Purpose
Post-stroke Cognitive Impairment
Status
Recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Angong Niuhuang Pill
Sponsored by
About this trial
This is an interventional treatment trial for Post-stroke Cognitive Impairment focused on measuring Post-stroke cognitive impairment;acupuncture
Eligibility Criteria
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. -
Sites / Locations
- 2nd Affiliated Hospital, School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Angong Niuhuang Pill Group
Angong Niuhuang pill combined with music electroacupuncture group
General control group
Arm Description
Take half an Angong Niuhuang pill every day for 4 weeks
Take half an Angong Niuhuang pill every day for 4 weeks and Daily music scalp acupuncture treatment
no intervention
Outcomes
Primary Outcome Measures
Simple intelligence state examination scale
MMSE
Secondary Outcome Measures
Full Information
NCT ID
NCT05731310
First Posted
February 7, 2023
Last Updated
February 7, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT05731310
Brief Title
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
Official Title
Efficacy Evaluation and Evaluation of Peripheral Neuroprotective Mechanism of Amgong Niuhuang Pill Combined With Supervised Pulse Music Electroacupuncture on Cognitive Impairment After Ischemic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-stroke Cognitive Impairment
Keywords
Post-stroke cognitive impairment;acupuncture
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
65 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Angong Niuhuang Pill Group
Arm Type
Experimental
Arm Description
Take half an Angong Niuhuang pill every day for 4 weeks
Arm Title
Angong Niuhuang pill combined with music electroacupuncture group
Arm Type
Experimental
Arm Description
Take half an Angong Niuhuang pill every day for 4 weeks and Daily music scalp acupuncture treatment
Arm Title
General control group
Arm Type
No Intervention
Arm Description
no intervention
Intervention Type
Drug
Intervention Name(s)
Angong Niuhuang Pill
Other Intervention Name(s)
Angong Niuhuang pill combined with music scalp acupuncture group
Intervention Description
Take Angong Niuhuang pill half a pill/day； Angong Niuhuang pill combined with music scalp acupuncture group These operations last for 4 weeks
Primary Outcome Measure Information:
Title
Simple intelligence state examination scale
Description
MMSE
Time Frame
up to 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
le zhang
Phone
86-13616511229
Email
2319053@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
le zhang
Organizational Affiliation
2nd Affiliated Hospital, School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
2nd Affiliated Hospital, School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
le zhang
Phone
86-13616511229
Email
2319053@zju.edu.cn
12. IPD Sharing Statement
Learn more about this trial
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
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