The Effect of Huperzine A Injection on Postoperative Cognitive Dysfunction in Patients With Aneurysmal Subarachnoid Hemorrhage: a Pilot Study
Huperzine A injection, operational treatment, the best basic treatment
+ operational treatment, the best basic treatment
+ Huperzine A injection, interventional treatment, the best basic treatment
Treatment Study
Summary
Study start date: September 30, 2022
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.60 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.4 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Group III
ExperimentalGroup IV
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, ChinaOpen Second Affiliated Hospital, School of Medicine, Zhejiang University in Google Maps