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

Phase 4

Recruiting

• Conditions: Cognitive Impairment After Brain Injury
• Interventions: Other: Median nerve electrical stimulation treatment; Drug: Huperzine A injection; Drug: Ginkgo leaf dropping pill

• Registration Number: NCT06704334
• Lead Sponsor: Wanbangde Pharmaceutical Group Co., LTD

Brief Summary

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

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 Timeline

• Study Start: 2024-04-01
• Study First Submitted: 2024-04-30
• Study First Submitted QC: 2024-11-22
• Study First Posted: 2024-11-26
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-11
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Huperzine A injection + median nerve electrical stimulation + Ginkgo leaf dropping pill group	Ginkgo leaf dropping pill	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.
Median nerve electrical stimulation group	Median nerve electrical stimulation treatment	The optimal median nerve electrical stimulation treatment was given
Huperzine A injection + median nerve electrical stimulation group	Median nerve electrical stimulation treatment	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.
Huperzine A injection + median nerve electrical stimulation group	Huperzine A injection	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.
Huperzine A injection + median nerve electrical stimulation + Ginkgo leaf dropping pill group	Median nerve electrical stimulation treatment	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.
Huperzine A injection + median nerve electrical stimulation + Ginkgo leaf dropping pill group	Huperzine A injection	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.

Primary Outcome Measures

Name	Time	Method
to assess the MMSE score	baseline，Day10，Day90

Secondary Outcome Measures

Name	Time	Method
to assess the MoCA score	baseline，Day10，Day90
to assess the ADAS-cog score	baseline，Day10，Day90
to assess the HAMD score	baseline，Day10，Day90
to assess the HAMA score	baseline，Day10，Day90

Trial Locations

Locations (1)

The Ganzhou City People's Hospital; 🇨🇳 Ganzhou, Jiang Xi province, China