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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

ConditionCognitive Impairment After Brain Injury
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorWanbangde Pharmaceutical Group Co., LTD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Be over 18 years old

Residual cognitive impairment due to brain injury

No previous history of brain-related diseases except this one

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Median nerve electrical stimulation treatment

    Other intervention

    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

    Drug

    intramuscular

  • Ginkgo leaf dropping pill

    Drug

    oral

Treatment groups

50 Participants
are divided into 3 treatment groups
Group A: Median nerve electrical stimulation groupExperimental treatment 1 intervention
Group B: Huperzine A injection + median nerve electrical stimulation groupExperimental treatment 2 interventions
Group C: Huperzine A injection + median nerve electrical stimulation + Ginkgo leaf dropping pill groupExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

to assess the Mini-Mental State Examination (MMSE) score

Mini-Mental State Examination (MMSE): total score ranges from 0 to 30. Higher scores indicate better cognitive function.

Time frame
baseline，Day10，Day90

Secondary outcomes

1

to assess the Montreal Cognitive Assessment (MoCA) score

Montreal Cognitive Assessment (MoCA): total score ranges from 0 to 30. Higher scores indicate better cognitive function.

Time frame
baseline，Day10，Day90
2

to assess the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-cog) score

Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog): total score ranges from 0 to 70. Higher scores indicate worse cognitive performance.

Time frame
baseline，Day10，Day90
3

to assess the Hamilton Depression Rating Scale (HAMD) score

Hamilton Depression Rating Scale (HAMD-24 item): total score ranges from 0 to 76. Higher scores indicate more severe depressive symptoms.

Time frame
baseline，Day10，Day90
4

to assess the Hamilton Anxiety Rating Scale (HAMA) score

Hamilton Anxiety Rating Scale (HAMA): total score ranges from 0 to 56. Higher scores indicate more severe anxiety symptoms.

Time frame
baseline，Day10，Day90

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wanbangde Pharmaceutical Group Co., LTD

Lead sponsor

Ganzhou City People's Hospital

Collaborator

Source ClinicalTrials.gov
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