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

Wanbangde Pharmaceutical Group

Status and phase: Enrolling; Phase 4

Conditions: Cognitive Impairment After Brain Injury

Treatments: Other: Median nerve electrical stimulation treatment; Drug: Huperzine A injection; Drug: Ginkgo leaf dropping pill

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06704334

2024-03-06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 3 patient groups

Median nerve electrical stimulation group

Experimental group

Description:

The optimal median nerve electrical stimulation treatment was given

Treatment:

Other: Median nerve electrical stimulation treatment

Huperzine A injection + median nerve electrical stimulation group

Experimental group

Description:

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.

Treatment:

Drug: Huperzine A injection

Other: Median nerve electrical stimulation treatment

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

Experimental group

Description:

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.

Treatment:

Drug: Ginkgo leaf dropping pill

Drug: Huperzine A injection

Other: Median nerve electrical stimulation treatment