Back to resultsThe Effect of Huperzine A Injection on Postoperative Cognitive Dysfunction in Patients With Aneurysmal Subarachnoid Hemorrhage: a Pilot Study
Primary Purpose
Postoperative Cognitive Dysfunction in Patients With Aneurysmal Subarachnoid Hemorrhage
Status
Not yet recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Huperzine A injection, operational treatment, the best basic treatment
operational treatment, the best basic treatment
Huperzine A injection, interventional treatment, the best basic treatment
Interventional treatment, the best basic treatment
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Cognitive Dysfunction in Patients With Aneurysmal Subarachnoid Hemorrhage
Eligibility 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.
Sites / Locations
- Second Affiliated Hospital, School of Medicine, Zhejiang University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Other
Experimental
Other
Arm Label
The operation group-The treatment group
The operation group-The control group
The intervention group-The treatment group
The intervention group-The control group
Arm Description
after operational treatment: ①the best basic treatment ②i.m. huperzine A injection (0.2mg), qd, 8d.
after operational treatment: ①the best basic treatment
after interventional treatment: ①the best basic treatment ②i.m. huperzine A injection (0.2mg), qd, 8d.
after interventional treatment: ①the best basic treatment
Outcomes
Primary Outcome Measures
Mini Mental Status Examination（MMSE ）
The seven items in the scale were used for scoring, and the degree of intellectual status and cognitive impairment before treatment, during follow-up and after treatment were compared within and between groups. The higher the score, the better the intellectual state of the subjects.
Secondary Outcome Measures
Hospital anxiety and depression Scale（HADS）
The anxiety and depression subscales of the Hospital Anxiety and Depression Scale were used to screen the anxiety and depression of the subjects before treatment, at the end of medication and at the visit period after discharge, and the intra group and inter group comparisons were made. The higher the score, the more serious the anxiety or depression.
The Short Form-36 Health Survey
Calculate the eight items in the scale. Before and after treatment, the scores of each items and the total score of body and psychology were compared within and between groups.
Modified Rankin Score
The functional recovery outcomes before treatment, at the end of medication and at the visit period after discharge were evaluated by using the modified Rankin scale, and compared within and between groups. The higher the score, the worse the functional recovery.
Biological sample detection
Biological samples were tested during the screening period, during the medication period, and after the medication period to obtain drug metabolomics analysis data and disease biomarker data, and intra-group and inter-group comparisons were performed.
Mini Mental Status Examination（MMSE ）
The seven items in the scale were used for scoring, and the degree of intellectual status and cognitive impairment before treatment, during follow-up and after treatment were compared within and between groups. The higher the score, the better the intellectual state of the subjects.
Full Information
NCT ID
NCT05560373
First Posted
September 21, 2022
Last Updated
September 26, 2022
Sponsor
Wanbangde Pharmaceutical Group Co., LTD
Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT05560373
Brief Title
The Effect of Huperzine A Injection on Postoperative Cognitive Dysfunction in Patients With Aneurysmal Subarachnoid Hemorrhage: a Pilot Study
Official Title
The Effect of Huperzine A Injection on Postoperative Cognitive Dysfunction in Patients With Aneurysmal Subarachnoid Hemorrhage: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 30, 2022 (Anticipated)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wanbangde Pharmaceutical Group Co., LTD
Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Cognitive Dysfunction in Patients With Aneurysmal Subarachnoid Hemorrhage
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
The operation group-The treatment group
Arm Type
Experimental
Arm Description
after operational treatment: ①the best basic treatment ②i.m. huperzine A injection (0.2mg), qd, 8d.
Arm Title
The operation group-The control group
Arm Type
Other
Arm Description
after operational treatment: ①the best basic treatment
Arm Title
The intervention group-The treatment group
Arm Type
Experimental
Arm Description
after interventional treatment: ①the best basic treatment ②i.m. huperzine A injection (0.2mg), qd, 8d.
Arm Title
The intervention group-The control group
Arm Type
Other
Arm Description
after interventional treatment: ①the best basic treatment
Intervention Type
Drug
Intervention Name(s)
Huperzine A injection, operational treatment, the best basic treatment
Intervention Description
intramuscular
Intervention Type
Other
Intervention Name(s)
operational treatment, the best basic treatment
Intervention Description
other
Intervention Type
Drug
Intervention Name(s)
Huperzine A injection, interventional treatment, the best basic treatment
Intervention Description
intramuscular
Intervention Type
Other
Intervention Name(s)
Interventional treatment, the best basic treatment
Intervention Description
other
Primary Outcome Measure Information:
Title
Mini Mental Status Examination（MMSE ）
Description
The seven items in the scale were used for scoring, and the degree of intellectual status and cognitive impairment before treatment, during follow-up and after treatment were compared within and between groups. The higher the score, the better the intellectual state of the subjects.
Time Frame
90 days after discharge
Secondary Outcome Measure Information:
Title
Hospital anxiety and depression Scale（HADS）
Description
The anxiety and depression subscales of the Hospital Anxiety and Depression Scale were used to screen the anxiety and depression of the subjects before treatment, at the end of medication and at the visit period after discharge, and the intra group and inter group comparisons were made. The higher the score, the more serious the anxiety or depression.
Time Frame
Screening period (day -4 to day 0), day 8, 30 days after discharge, 90 days after discharge and 180 days after discharge
Title
The Short Form-36 Health Survey
Description
Calculate the eight items in the scale. Before and after treatment, the scores of each items and the total score of body and psychology were compared within and between groups.
Time Frame
Screening period (day -4 to day 0), 30 days after discharge, 90 days after discharge and 180 days after discharge
Title
Modified Rankin Score
Description
The functional recovery outcomes before treatment, at the end of medication and at the visit period after discharge were evaluated by using the modified Rankin scale, and compared within and between groups. The higher the score, the worse the functional recovery.
Time Frame
Screening period (day -4 to day 0), day 8, 30 days after discharge, 90 days after discharge and 180 days after discharge
Title
Biological sample detection
Description
Biological samples were tested during the screening period, during the medication period, and after the medication period to obtain drug metabolomics analysis data and disease biomarker data, and intra-group and inter-group comparisons were performed.
Time Frame
Screening period (day -4 to day 0), day 2, day 3, day 8
Title
Mini Mental Status Examination（MMSE ）
Description
The seven items in the scale were used for scoring, and the degree of intellectual status and cognitive impairment before treatment, during follow-up and after treatment were compared within and between groups. The higher the score, the better the intellectual state of the subjects.
Time Frame
Screening period (day -4 to day 0), day2, day 3, day 8, 30 days after discharge and 180 days after discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chen Jingsen
Phone
13666669121
Email
furycjs@126.com
Facility Information:
Facility Name
Second Affiliated Hospital, School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen Jingsen
Phone
13666669121
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Huperzine A Injection on Postoperative Cognitive Dysfunction in Patients With Aneurysmal Subarachnoid Hemorrhage: a Pilot Study
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