Cognitive Impairment After Brain InjuryPhase 4NCT06704334
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
A Phase 4 study testing Median nerve electrical stimulation treatment, Huperzine A injection and Ginkgo leaf dropping pill in people with Cognitive Impairment After Brain Injury, run by Wanbangde Pharmaceutical Group Co., LTD at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cognitive Impairment After Brain Injury
- What is being tested?
- Median nerve electrical stimulation treatment, Huperzine A injection and Ginkgo leaf dropping pill
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be over 18 years old
- Residual cognitive impairment due to brain injury
- No previous history of brain-related diseases except this one
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Ganzhou City People's Hospital
Ganzhou, Jiangxi, 8112320
Dong Wang, 18007076858, 2623693068@qq.com
Dong Wang
About this study
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.
Read the 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.
- Conditions
- Cognitive Impairment After Brain Injury
- Being tested
- Median nerve electrical stimulation treatment, Huperzine A injection, Ginkgo leaf dropping pill
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Median nerve electrical stimulation treatmentOther
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 injectionDrug
intramuscular
Ginkgo leaf dropping pillDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| Median nerve electrical stimulation group | Experimental | The optimal median nerve electrical stimulation treatment was given Receives: Other: Median nerve electrical stimulation treatment |
| Huperzine A injection + median nerve electrical stimulation group | Experimental | 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. Receives: Other: Median nerve electrical stimulation treatment; Drug: Huperzine A injection |
| Huperzine A injection + median nerve electrical stimulation + Ginkgo leaf dropping pill group | Experimental | 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. Receives: Other: Median nerve electrical stimulation treatment; Drug: Huperzine A injection; Drug: Ginkgo leaf dropping pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline，Day10，Day90
Secondary outcomes (4)
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.
Measured: baseline，Day10，Day90
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.
Measured: baseline，Day10，Day90
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.
Measured: baseline，Day10，Day90
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.
Measured: baseline，Day10，Day90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start1 Apr 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Impairment After Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wanbangde Pharmaceutical Group Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ganzhou City People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06704334
- Sponsor's protocol ID
- TY-ZKY2023-102-01
- Status last verified
- Aug 2026
- First submitted
- 30 Apr 2024
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06704334
- Acronym / sponsor ID
- TY-ZKY2023-102-01
- Conditions
- Cognitive Impairment After Brain Injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Wanbangde Pharmaceutical Group Co., LTDIndustry (pharma, biotech, devices)
- Collaborators
- Ganzhou City People's Hospital
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Median nerve electrical stimulation group | Experimental | Other: Median nerve electrical stimulation treatmentThe optimal median nerve electrical stimulation treatment was given |
| Huperzine A injection + median nerve electrical stimulation group | Experimental | Other: Median nerve electrical stimulation treatment, Drug: Huperzine A injectionHuperzine 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 | Experimental | Other: Median nerve electrical stimulation treatment, Drug: Huperzine A injection, Drug: Ginkgo leaf dropping pillHuperzine 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Be over 18 years old
- Residual cognitive impairment due to brain injury
- No previous history of brain-related diseases except this one
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Median nerve electrical stimulation treatmentMedian 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. | Other | Huperzine A injection + median nerve electrical stimulation + Ginkgo leaf dropping pill group, Huperzine A injection + median nerve electrical stimulation group, Median nerve electrical stimulation group |
| Huperzine A injectionintramuscular | Drug | Huperzine A injection + median nerve electrical stimulation + Ginkgo leaf dropping pill group, Huperzine A injection + median nerve electrical stimulation group |
| Ginkgo leaf dropping pilloral | Drug | Huperzine A injection + median nerve electrical stimulation + Ginkgo leaf dropping pill group |
Primary outcome
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.
4 secondary outcomes
to assess the Montreal Cognitive Assessment (MoCA) score
Time frame: baseline，Day10，Day90
to assess the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-cog) score
Time frame: baseline，Day10，Day90
to assess the Hamilton Depression Rating Scale (HAMD) score
Time frame: baseline，Day10，Day90
to assess the Hamilton Anxiety Rating Scale (HAMA) score
Time frame: baseline，Day10，Day90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Median nerve electrical stimulation treatment, Huperzine A injection and Ginkgo leaf dropping pill in people with Cognitive Impairment After Brain Injury, run by Wanbangde Pharmaceutical Group Co., LTD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dong Wang (18007076858, 2623693068@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to assess the Mini-Mental State Examination (MMSE) score (time frame: baseline，Day10，Day90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.