Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2026-02-21 @ 11:35 PM
Study NCT ID:
NCT06704334
Status:
RECRUITING
Last Update Posted:
2024-12-11
First Post:
2024-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief 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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C050426', 'term': 'huperzine A'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-05', 'studyFirstSubmitDate': '2024-04-30', 'studyFirstSubmitQcDate': '2024-11-22', 'lastUpdatePostDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to assess the MMSE score', 'timeFrame': 'baseline，Day10，Day90'}], 'secondaryOutcomes': [{'measure': 'to assess the MoCA score', 'timeFrame': 'baseline，Day10，Day90'}, {'measure': 'to assess the ADAS-cog score', 'timeFrame': 'baseline，Day10，Day90'}, {'measure': 'to assess the HAMD score', 'timeFrame': 'baseline，Day10，Day90'}, {'measure': 'to assess the HAMA score', 'timeFrame': 'baseline，Day10，Day90'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cognitive Impairment After Brain Injury']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be over 18 years old\n\n * Residual cognitive impairment due to brain injury\n\n * No previous history of brain-related diseases except this one\n\nExclusion Criteria:\n\n* The patient had severe underlying disease and unstable vital signs\n\n * 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'}, 'identificationModule': {'nctId': 'NCT06704334', 'briefTitle': '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', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wanbangde Pharmaceutical Group Co., LTD'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '2024-03-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Median nerve electrical stimulation group', 'description': 'The optimal median nerve electrical stimulation treatment was given', 'interventionNames': ['Other: Median nerve electrical stimulation treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Huperzine A injection + median nerve electrical stimulation group', 'description': 'Huperzine A injection can be administered before median nerve electrical stimulation to improve the therapeutic effect of electrical stimulation.\n\nHuperzine A injection: intramuscular injection, 1ml,0.2mg once a day, the course of treatment was 7 days.', 'interventionNames': ['Other: Median nerve electrical stimulation treatment', 'Drug: Huperzine A injection']}, {'type': 'EXPERIMENTAL', 'label': 'Huperzine A injection + median nerve electrical stimulation + Ginkgo leaf dropping pill 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.\n\nHuperzine A injection: intramuscular injection, 1ml,0.2mg once a day, the course of treatment was 7 days.\n\nGinkgo leaf dropping pills: Oral, each pill weighs 63mg, 5 pills/time, 3 times/day, the course of treatment is 3 months.', 'interventionNames': ['Other: Median nerve electrical stimulation treatment', 'Drug: Huperzine A injection', 'Drug: Ginkgo leaf dropping pill']}], 'interventions': [{'name': 'Median nerve electrical stimulation treatment', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['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']}, {'name': 'Huperzine A injection', 'type': 'DRUG', 'description': 'intramuscular', 'armGroupLabels': ['Huperzine A injection + median nerve electrical stimulation + Ginkgo leaf dropping pill group', 'Huperzine A injection + median nerve electrical stimulation group']}, {'name': 'Ginkgo leaf dropping pill', 'type': 'DRUG', 'description': 'oral', 'armGroupLabels': ['Huperzine A injection + median nerve electrical stimulation + Ginkgo leaf dropping pill group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8112320', 'city': 'Ganzhou', 'state': 'Jiangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dong Wang', 'role': 'CONTACT', 'email': '2623693068@qq.com', 'phone': '18007076858'}, {'name': 'Dong Wang', 'role': 'CONTACT'}], 'facility': "The Ganzhou City People's Hospital", 'geoPoint': {'lat': 25.84664, 'lon': 114.9326}}], 'centralContacts': [{'name': 'Dong Wang', 'role': 'CONTACT', 'email': '2623693068@qq.com', 'phone': '18007076858'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wanbangde Pharmaceutical Group Co., LTD', 'class': 'INDUSTRY'}, 'collaborators': [{'name': "Ganzhou City People's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}