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

NCT05731310 | Unknown Early Phase 1

• 1 other identifier: 2022-0507
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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

Conditions

Post-stroke Cognitive Impairment

Keywords

Post-stroke cognitive impairment;acupuncture

Outcome Measures

Primary Outcomes (1)

• Simple intelligence state examination scale

  MMSE

  up to 4 weeks

Study Arms (3)

Angong Niuhuang Pill Group

EXPERIMENTAL

Take half an Angong Niuhuang pill every day for 4 weeks

Drug: Angong Niuhuang Pill

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

Drug: Angong Niuhuang Pill

General control group

NO INTERVENTION

no intervention

Interventions

Angong Niuhuang Pill DRUG

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

Also known as: Angong Niuhuang pill combined with music scalp acupuncture group

Angong Niuhuang Pill Group; Angong Niuhuang pill combined with music electroacupuncture group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2nd Affiliated Hospital, School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Interventions

Angong Niuhuang Pill

Study Officials

• le zhang

  2nd Affiliated Hospital, School of Medicine

  STUDY CHAIR

Central Study Contacts

le zhang

CONTACT

86-13616511229; 2319053@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: February 16, 2023
• Study Start: August 1, 2022
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: February 16, 2023

Record last verified: 2023-02

Locations

CN (1)