The Effect of Huperzine A Injection on Postoperative Cognitive Dysfunction in Patients With Aneurysmal Subarachnoid Hemorrhage: a Pilot Study

NCT ID: NCT05560373

Last Updated: 2022-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-30

Study Completion Date

2024-09-30

Brief Summary

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Under the premise of basic treatment, to explore the improvement effect of huperzine A injection on short-term and long-term neurocognitive dysfunction in patients with aneurysmal subarachnoid hemorrhage after interventional/surgical treatment.

Detailed Description

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Description: This is a randomized, controlled, single center, exploratory clinical trial. The subjects are divided into surgical treatment group and interventional treatment group. Each group is divided into test group and control group. The test group is given huperzine A injection (0.2mg/dose) every day, intramuscular injection, for a total of 8 days, and basic treatment is given at the same time; The control group was given basic treatment, and did not receive other neurotrophic drugs except basic drugs. This clinical trial is to evaluate the effect of huperzine A injection on the improvement of postoperative cognitive dysfunction in patients with aneurysmal subarachnoid hemorrhage.

Conditions

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Postoperative Cognitive Dysfunction in Patients With Aneurysmal Subarachnoid Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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The operation group-The treatment group

after operational treatment: ①the best basic treatment ②i.m. huperzine A injection (0.2mg), qd, 8d.

Group Type EXPERIMENTAL

Huperzine A injection, operational treatment, the best basic treatment

Intervention Type DRUG

intramuscular

The operation group-The control group

after operational treatment: ①the best basic treatment

Group Type OTHER

operational treatment, the best basic treatment

Intervention Type OTHER

other

The intervention group-The treatment group

after interventional treatment: ①the best basic treatment ②i.m. huperzine A injection (0.2mg), qd, 8d.

Group Type EXPERIMENTAL

Huperzine A injection, interventional treatment, the best basic treatment

Intervention Type DRUG

intramuscular

The intervention group-The control group

after interventional treatment: ①the best basic treatment

Group Type OTHER

Interventional treatment, the best basic treatment

Intervention Type OTHER

other

Interventions

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Huperzine A injection, operational treatment, the best basic treatment

intramuscular

Intervention Type DRUG

operational treatment, the best basic treatment

other

Intervention Type OTHER

Huperzine A injection, interventional treatment, the best basic treatment

intramuscular

Intervention Type DRUG

Interventional treatment, the best basic treatment

other

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age 18-70;

* The patients were proved to be aneurysmal subarachnoid hemorrhage by imaging examination (head CT, CT angiography (CTA), whole brain angiography (DSA));

* Hunt Hess was graded I-III at admission;

* The patients were treated with endovascular therapy or craniotomy and clipping surgery;

* The time from the onset of aSAH symptoms to admission ≤ 72 hours; ⑥ The subject himself or the guardian of the subject knew and voluntarily signed the informed consent form.

Exclusion Criteria

* Non aneurysmal subarachnoid hemorrhage;

* Cognitive dysfunction existed before onset;

* Patients with angina pectoris, bronchial asthma, mechanical intestinal obstruction, liver and kidney insufficiency, and urinary tract obstruction;

* Complicated with other nervous system diseases, including nervous system degenerative diseases (Alzheimer's disease, Parkinson's disease, Lewy body dementia, frontotemporal dementia, etc.), neuromyelitis optica, epilepsy, central nervous system infection (such as AIDS, syphilis, etc.), brain traumatic dementia, etc;

* Psychotic patients, according to DSM-IV-TR standards, including schizophrenia or other mental diseases, bipolar disorder, major depression or delirium;

* Other cholinesterase inhibitor drugs are being used; ⑦ There are uncorrectable visual and auditory disorders, and neuropsychological tests and scales cannot be completed;

* Have unstable or serious heart, lung, liver, kidney and hematopoietic system diseases;

* Pregnant or lactating women and women of childbearing age without reliable contraception, and there is no evidence of negative pregnancy; ⑩ Patients who cannot be followed up as required during the study period; ⑪ Those who are allergic to the test drug; ⑫ Those who have participated in other clinical trials in recent 3 months; ⑬ Patients who are not suitable to participate in the clinical trial.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role collaborator

Wanbangde Pharmaceutical Group Co., LTD

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Central Contacts

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Chen Jingsen

Role: CONTACT

13666669121

Facility Contacts

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Chen Jingsen

Role: primary

13666669121

Other Identifiers

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20220784

Identifier Type: -

Identifier Source: org_study_id

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