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

August 13, 2026 updated by: Wanbangde Pharmaceutical Group Co., LTD
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 4

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
    • Jiangxi
      • Ganzhou, Jiangxi, China, 8112320
        • Recruiting
        • The Ganzhou City People's Hospital
        • Contact:
        • Principal Investigator:
          • Dong Wang

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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
  • Allergic to drugs or contraindications in drug use
  • There are contraindications of median nerve electrical stimulation

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Median nerve electrical stimulation group
The optimal median nerve electrical stimulation treatment was given
Other: 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.
Experimental: 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.
Drug: Huperzine A injection
intramuscular
Other: 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.
Experimental: 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.
Drug: Huperzine A injection
intramuscular
Other: 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.
Drug: Ginkgo leaf dropping pill
oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
to assess the Mini-Mental State Examination (MMSE) score
Time Frame: baseline，Day10，Day90
Mini-Mental State Examination (MMSE): total score ranges from 0 to 30. Higher scores indicate better cognitive function.
baseline，Day10，Day90

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
to assess the Montreal Cognitive Assessment (MoCA) score
Time Frame: baseline，Day10，Day90
Montreal Cognitive Assessment (MoCA): total score ranges from 0 to 30. Higher scores indicate better cognitive function.
baseline，Day10，Day90
to assess the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-cog) score
Time Frame: baseline，Day10，Day90
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog): total score ranges from 0 to 70. Higher scores indicate worse cognitive performance.
baseline，Day10，Day90
to assess the Hamilton Depression Rating Scale (HAMD) score
Time Frame: baseline，Day10，Day90
Hamilton Depression Rating Scale (HAMD-24 item): total score ranges from 0 to 76. Higher scores indicate more severe depressive symptoms.
baseline，Day10，Day90
to assess the Hamilton Anxiety Rating Scale (HAMA) score
Time Frame: baseline，Day10，Day90
Hamilton Anxiety Rating Scale (HAMA): total score ranges from 0 to 56. Higher scores indicate more severe anxiety symptoms.
baseline，Day10，Day90

Collaborators and Investigators

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

Sponsor

Wanbangde Pharmaceutical Group Co., LTD

Collaborators

Ganzhou City People's Hospital

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)

April 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

April 30, 2024

First Submitted That Met QC Criteria

November 22, 2024

First Posted (Actual)

November 26, 2024

Study Record Updates

Last Update Posted (Actual)

August 17, 2026

Last Update Submitted That Met QC Criteria

August 13, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TY-ZKY2023-102-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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