The Study of Ginkgo Leaf Dropping Pills and Huperzine a Injection Combined with Median Nerve Electrical Stimulation in the Treatment of Cognitive Impairment After Brain Injury

NCT ID: NCT06704334

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2026-12-31

Brief Summary

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This study will conduct a single-center clinical trial to explore the initial therapeutic effect of ginkgo biloba dropping pills, huperzine A injection and median nerve electrical stimulation in patients with cognitive impairment.

Detailed Description

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Specific experimental research methods were randomized, controlled, single-center, exploratory clinical study, through the treatment of ginkgo biloba dropping pills, huperzine A injection and median nerve electrical stimulation in patients with cognitive impairment, to observe the effects of their neuroprotection and cognitive function improvement.

Conditions

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Cognitive Impairment After Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Median nerve electrical stimulation group

The optimal median nerve electrical stimulation treatment was given

Group Type EXPERIMENTAL

Median nerve electrical stimulation treatment

Intervention Type OTHER

Median nerve electrical stimulation is an electrical stimulation therapy in which the electrode is placed at the median nerve point 2cm above the carpal wrinkles on the palmar surface of the wrist joint. Generally, the right median nerve is used for electrical stimulation. Electrical stimulation improves cognitive function by stimulating neurons in the brain and improving information transmission between neurons. When electrical current stimulates the brain, it can increase the activity level of neurons and promote the signal transmission between neurons. Its mechanism of action includes the regulation of neurotransmitter acetylcholine, thereby enhancing cognitive function.

Huperzine A injection + median nerve electrical stimulation group

Huperzine A injection can be administered before median nerve electrical stimulation to improve the therapeutic effect of electrical stimulation.

Huperzine A injection: intramuscular injection, 1ml,0.2mg once a day, the course of treatment was 7 days.

Group Type EXPERIMENTAL

Median nerve electrical stimulation treatment

Intervention Type OTHER

Median nerve electrical stimulation is an electrical stimulation therapy in which the electrode is placed at the median nerve point 2cm above the carpal wrinkles on the palmar surface of the wrist joint. Generally, the right median nerve is used for electrical stimulation. Electrical stimulation improves cognitive function by stimulating neurons in the brain and improving information transmission between neurons. When electrical current stimulates the brain, it can increase the activity level of neurons and promote the signal transmission between neurons. Its mechanism of action includes the regulation of neurotransmitter acetylcholine, thereby enhancing cognitive function.

Huperzine A injection

Intervention Type DRUG

intramuscular

Huperzine A injection + median nerve electrical stimulation + Ginkgo leaf dropping pill group

Huperzine A injection can be administered before median nerve electrical stimulation to improve the therapeutic effect of electrical stimulation. After the end of the electrical stimulation treatment, ginkgo biloba dropping pills were given as long-term administration to maintain the therapeutic effect.

Huperzine A injection: intramuscular injection, 1ml,0.2mg once a day, the course of treatment was 7 days.

Ginkgo leaf dropping pills: Oral, each pill weighs 63mg, 5 pills/time, 3 times/day, the course of treatment is 3 months.

Group Type EXPERIMENTAL

Median nerve electrical stimulation treatment

Intervention Type OTHER

Median nerve electrical stimulation is an electrical stimulation therapy in which the electrode is placed at the median nerve point 2cm above the carpal wrinkles on the palmar surface of the wrist joint. Generally, the right median nerve is used for electrical stimulation. Electrical stimulation improves cognitive function by stimulating neurons in the brain and improving information transmission between neurons. When electrical current stimulates the brain, it can increase the activity level of neurons and promote the signal transmission between neurons. Its mechanism of action includes the regulation of neurotransmitter acetylcholine, thereby enhancing cognitive function.

Huperzine A injection

Intervention Type DRUG

intramuscular

Ginkgo leaf dropping pill

Intervention Type DRUG

oral

Interventions

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Median nerve electrical stimulation treatment

Median nerve electrical stimulation is an electrical stimulation therapy in which the electrode is placed at the median nerve point 2cm above the carpal wrinkles on the palmar surface of the wrist joint. Generally, the right median nerve is used for electrical stimulation. Electrical stimulation improves cognitive function by stimulating neurons in the brain and improving information transmission between neurons. When electrical current stimulates the brain, it can increase the activity level of neurons and promote the signal transmission between neurons. Its mechanism of action includes the regulation of neurotransmitter acetylcholine, thereby enhancing cognitive function.

Intervention Type OTHER

Huperzine A injection

intramuscular

Intervention Type DRUG

Ginkgo leaf dropping pill

oral

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Be over 18 years old

* Residual cognitive impairment due to brain injury

* No previous history of brain-related diseases except this one

Exclusion Criteria

* The patient had severe underlying disease and unstable vital signs

* The patient was complicated with consciousness disorder and could not cooperate with cognitive function assessment ③ Allergic to drugs or contraindications in drug use ④ There are contraindications of median nerve electrical stimulation
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ganzhou City People's Hospital

OTHER

Sponsor Role collaborator

Wanbangde Pharmaceutical Group Co., LTD

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Ganzhou City People's Hospital

Ganzhou, Jiangxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Dong Wang

Role: CONTACT

Phone: 18007076858

Email: [email protected]

Facility Contacts

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Dong Wang

Role: primary

Dong Wang

Role: backup

Other Identifiers

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2024-03-06

Identifier Type: -

Identifier Source: org_study_id