Back to resultsClinical Study of Huperzine A in the Treatment of Patients With Hypertensive Cerebral Hemorrhage
Primary Purpose
Neurosensory Disorder
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Huperzine A for Injection
Sponsored by
About this trial
This is an interventional treatment trial for Neurosensory Disorder
Eligibility Criteria
Inclusion Criteria:
- Aged from 18 to 75 years old(including 18 and 75 years old), males or females;
- First onset, clinical diagnosis of hypertensive intracerebral hemorrhage, and CT confirmed that the amount of hemorrhage is between 15ml-50ml, the bleeding site is the basal ganglia, the bleeding has not penetrated into the lateral ventricle, and non-surgical patients；
- Those with obvious neurological dysfunction after the onset, 5≤GCS≤15 or NIHSS≥6；
- Admission within 72 hours after the onset of the disease, and no significant enlargement of the hematoma within 24 hours after admission (hematoma enlargement ≤ 5ml)；
- The patient/family knows and signs the informed consent form voluntarily.
Exclusion Criteria:
- Cerebral hemorrhage caused by cerebral aneurysm, brain tumor, brain trauma, cerebral parasitic disease, cerebrovascular malformation, abnormal blood vessel network at the base of the brain, cerebral arteritis, blood disease, metabolic disorder and other diseases confirmed by examination;
- Patients with enlarged hematoma found within 24 hours after admission (the volume of enlarged hematoma> 5ml);
- Patients with simple transient ischemic attack, lacunar infarction, subarachnoid hemorrhage and ischemic cerebral infarction;
- Patients who use anticoagulant drugs for a long time;
- Patients with platelet count <100,000, INR>1.4 at admission and abnormal blood coagulation function;
- The measured value of homocysteine at admission is higher than 15μmol/L;
- Patients who need surgical treatment (including ventricular drainage);
- Patients with severe primary diseases such as cardiovascular, liver (ALT or AST>1.5 times the upper limit of normal), kidneys (BUN>1.5 times the upper limit of normal and Cr>upper limit of normal), endocrine system and hematopoietic system;
- Those who are allergic to protein and test drugs;
- People who are dependent on drugs or alcohol;
- Intended pregnancy or women of childbearing age with positive pregnancy test and lactating women;
- Participated in other clinical trials within the past 3 months;
- Patients considered by the investigator to be inappropriate to participate in clinical trials.
Sites / Locations
- The Fifth Affiliated Hospital of Zhengzhou University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental：Huperzine A for Injection+Basic treatment
Control：Basic treatment
Arm Description
Huperzine A for Injection: Dissolve each bottle with 2ml sterile water for injection and inject into muscle, the course of treatment is 14 days； Basic treatment：Control blood pressure; prevent continued bleeding; prevent and treat gastrointestinal bleeding; decide whether to perform dehydration treatment according to the condition to reduce cerebral edema; prevent infection, prevent various complications, etc.; routine rehabilitation training.
Basic treatment：Control blood pressure; prevent continued bleeding; prevent and treat gastrointestinal bleeding; decide whether to perform dehydration treatment according to the condition to reduce cerebral edema; prevent infection, prevent various complications, etc.; routine rehabilitation training.
Outcomes
Primary Outcome Measures
Extension of Glasgow Outcome Scale(GOSE) Scores at 90 days of treatment
At the 90-day follow-up of patients, the extended Glasgow Outcome Scale (GOSE) was used to assess and judge the difference in consciousness after stroke between the two groups. The scores of minimum values is 1, the maximum values is 8, whether higher scores mean a better outcome.
Secondary Outcome Measures
Extension of Glasgow Outcome Scale(GOSE) Scores at 30 days of treatment
At the 30-day follow-up of patients, the extended Glasgow Outcome Scale (GOSE) was used to assess and judge the difference in consciousness after stroke between the two groups. The scores of minimum values is 1, the maximum values is 8, whether higher scores mean a better outcome.
Scores of Modified Rankin Scale(mRS) at 14 days of treatment
At 14 days of treatment, the two groups of patients were scored with scores of Modified Rankin Scale(mRS). The mRS score of the two groups were compared whether there were statistical differences. The scores of minimum values is 0, the maximum values is 5, whether higher scores mean a worse outcome.
Scores of Modified Rankin Scale(mRS) at 30 days of treatment
At 30 days of treatment, the two groups of patients were scored with scores of Modified Rankin Scale(mRS). The mRS score of the two groups were compared whether there were statistical differences.The scores of minimum values is 0, the maximum values is 5, whether higher scores mean a worse outcome.
Scores of Modified Rankin Scale(mRS) at 90 days of treatment
At 90 days of treatment, the two groups of patients were scored with scores of Modified Rankin Scale(mRS). The mRS score of the two groups were compared whether there were statistical differences.The scores of minimum values is 0, the maximum values is 5, whether higher scores mean a worse outcome.
Scores of National Institute of Health stroke scale(NIHSS) at 14 days of treatment
At 14 days of treatment, the two groups of patients were scored with scores of National Institute of Health stroke scale(NIHSS). The NIHSS score of the two groups were compared whether there were statistical differences. The scores of minimum values is 0, the maximum values is 42, whether higher scores mean a worse outcome.
Scores of National Institute of Health stroke scale(NIHSS) at 30 days of treatment
At 30 days of treatment, the two groups of patients were scored with scores of National Institute of Health stroke scale(NIHSS). The NIHSS score of the two groups were compared whether there were statistical differences. The scores of minimum values is 0, the maximum values is 42, whether higher scores mean a worse outcome.
Scores of National Institute of Health stroke scale(NIHSS) at 90 days of treatment
At 90 days of treatment, the two groups of patients were scored with scores of National Institute of Health stroke scale(NIHSS). The NIHSS score of the two groups were compared whether there were statistical differences. The scores of minimum values is 0, the maximum values is 42, whether higher scores mean a worse outcome.
Scores of the Barthelindex of ADL at 14 days of treatment
At 14 days of treatment, the two groups of patients were scored with scores of Barthelindex of ADL. The Barthelindex of ADL scores of the two groups were compared whether there were statistical differences. The scores of minimum values is 0, the maximum values is 100, whether higher scores mean a better outcome.
Scores of the Barthelindex of ADL at 30 days of treatment
At 30 days of treatment, the two groups of patients were scored with scores of Barthelindex of ADL. The Barthelindex of ADL scores of the two groups were compared whether there were statistical differences. The scores of minimum values is 0, the maximum values is 100, whether higher scores mean a better outcome.
Scores of the Barthelindex of ADL at 90 days of treatment
At 90 days of treatment, the two groups of patients were scored with scores of Barthelindex of ADL. The Barthelindex of ADL scores of the two groups were compared whether there were statistical differences. The scores of minimum values is 0, the maximum values is 100, whether higher scores mean a better outcome.
Complication rate
After 90 days of treatment, compare whether the incidence of complications (including epilepsy, hydrocephalus, infarction, rebleeding, pneumonia, gastrointestinal hemorrhage) between the two groups is statistically different
Full Information
NCT ID
NCT04509323
First Posted
July 22, 2020
Last Updated
August 9, 2020
Sponsor
Jiangsu Famous Medical Technology Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04509323
Brief Title
Clinical Study of Huperzine A in the Treatment of Patients With Hypertensive Cerebral Hemorrhage
Official Title
A Randomized, Controlled, Single-center Clinical Study of Huperzine A in the Treatment of Brain Injury in Patients With Hypertensive Cerebral Hemorrhage
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 3, 2020 (Anticipated)
Primary Completion Date
February 28, 2021 (Anticipated)
Study Completion Date
May 28, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Famous Medical Technology Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the effectiveness of Huperzine A injection in the treatment of brain injury in patients with hypertensive cerebral hemorrhage；
To evaluate the safety of Huperzine A injection in the treatment of brain injury in patients with hypertensive cerebral hemorrhage。
Detailed Description
A randomized, controlled, single-center, exploratory clinical research method was used. In the treatment plan, the experimental group used basic treatment + Huperzine A, and the control group only used basic treatment, with a total of 20 cases. To evaluate the effectiveness and safety of Huperzine A injection in the treatment of brain injury in patients with hypertensive cerebral hemorrhage.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurosensory Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Patients with hypertensive basal ganglia cerebral hemorrhage
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental：Huperzine A for Injection+Basic treatment
Arm Type
Experimental
Arm Description
Huperzine A for Injection: Dissolve each bottle with 2ml sterile water for injection and inject into muscle, the course of treatment is 14 days； Basic treatment：Control blood pressure; prevent continued bleeding; prevent and treat gastrointestinal bleeding; decide whether to perform dehydration treatment according to the condition to reduce cerebral edema; prevent infection, prevent various complications, etc.; routine rehabilitation training.
Arm Title
Control：Basic treatment
Arm Type
No Intervention
Arm Description
Basic treatment：Control blood pressure; prevent continued bleeding; prevent and treat gastrointestinal bleeding; decide whether to perform dehydration treatment according to the condition to reduce cerebral edema; prevent infection, prevent various complications, etc.; routine rehabilitation training.
Intervention Type
Drug
Intervention Name(s)
Huperzine A for Injection
Intervention Description
Give the patient one intramuscular injection (0.2mg) of Huperzine A of injection once a day for 14 days
Primary Outcome Measure Information:
Title
Extension of Glasgow Outcome Scale(GOSE) Scores at 90 days of treatment
Description
At the 90-day follow-up of patients, the extended Glasgow Outcome Scale (GOSE) was used to assess and judge the difference in consciousness after stroke between the two groups. The scores of minimum values is 1, the maximum values is 8, whether higher scores mean a better outcome.
Time Frame
At the 90-day
Secondary Outcome Measure Information:
Title
Extension of Glasgow Outcome Scale(GOSE) Scores at 30 days of treatment
Description
At the 30-day follow-up of patients, the extended Glasgow Outcome Scale (GOSE) was used to assess and judge the difference in consciousness after stroke between the two groups. The scores of minimum values is 1, the maximum values is 8, whether higher scores mean a better outcome.
Time Frame
At the 30-day
Title
Scores of Modified Rankin Scale(mRS) at 14 days of treatment
Description
At 14 days of treatment, the two groups of patients were scored with scores of Modified Rankin Scale(mRS). The mRS score of the two groups were compared whether there were statistical differences. The scores of minimum values is 0, the maximum values is 5, whether higher scores mean a worse outcome.
Time Frame
At the 14-day
Title
Scores of Modified Rankin Scale(mRS) at 30 days of treatment
Description
At 30 days of treatment, the two groups of patients were scored with scores of Modified Rankin Scale(mRS). The mRS score of the two groups were compared whether there were statistical differences.The scores of minimum values is 0, the maximum values is 5, whether higher scores mean a worse outcome.
Time Frame
At the 30-day
Title
Scores of Modified Rankin Scale(mRS) at 90 days of treatment
Description
At 90 days of treatment, the two groups of patients were scored with scores of Modified Rankin Scale(mRS). The mRS score of the two groups were compared whether there were statistical differences.The scores of minimum values is 0, the maximum values is 5, whether higher scores mean a worse outcome.
Time Frame
At the 90-day
Title
Scores of National Institute of Health stroke scale(NIHSS) at 14 days of treatment
Description
At 14 days of treatment, the two groups of patients were scored with scores of National Institute of Health stroke scale(NIHSS). The NIHSS score of the two groups were compared whether there were statistical differences. The scores of minimum values is 0, the maximum values is 42, whether higher scores mean a worse outcome.
Time Frame
At the 14-day
Title
Scores of National Institute of Health stroke scale(NIHSS) at 30 days of treatment
Description
At 30 days of treatment, the two groups of patients were scored with scores of National Institute of Health stroke scale(NIHSS). The NIHSS score of the two groups were compared whether there were statistical differences. The scores of minimum values is 0, the maximum values is 42, whether higher scores mean a worse outcome.
Time Frame
At the 30-day
Title
Scores of National Institute of Health stroke scale(NIHSS) at 90 days of treatment
Description
At 90 days of treatment, the two groups of patients were scored with scores of National Institute of Health stroke scale(NIHSS). The NIHSS score of the two groups were compared whether there were statistical differences. The scores of minimum values is 0, the maximum values is 42, whether higher scores mean a worse outcome.
Time Frame
At the 90-day
Title
Scores of the Barthelindex of ADL at 14 days of treatment
Description
At 14 days of treatment, the two groups of patients were scored with scores of Barthelindex of ADL. The Barthelindex of ADL scores of the two groups were compared whether there were statistical differences. The scores of minimum values is 0, the maximum values is 100, whether higher scores mean a better outcome.
Time Frame
At the 14-day
Title
Scores of the Barthelindex of ADL at 30 days of treatment
Description
At 30 days of treatment, the two groups of patients were scored with scores of Barthelindex of ADL. The Barthelindex of ADL scores of the two groups were compared whether there were statistical differences. The scores of minimum values is 0, the maximum values is 100, whether higher scores mean a better outcome.
Time Frame
At the 30-day
Title
Scores of the Barthelindex of ADL at 90 days of treatment
Description
At 90 days of treatment, the two groups of patients were scored with scores of Barthelindex of ADL. The Barthelindex of ADL scores of the two groups were compared whether there were statistical differences. The scores of minimum values is 0, the maximum values is 100, whether higher scores mean a better outcome.
Time Frame
At the 90-day
Title
Complication rate
Description
After 90 days of treatment, compare whether the incidence of complications (including epilepsy, hydrocephalus, infarction, rebleeding, pneumonia, gastrointestinal hemorrhage) between the two groups is statistically different
Time Frame
At the 90-day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged from 18 to 75 years old(including 18 and 75 years old), males or females;
First onset, clinical diagnosis of hypertensive intracerebral hemorrhage, and CT confirmed that the amount of hemorrhage is between 15ml-50ml, the bleeding site is the basal ganglia, the bleeding has not penetrated into the lateral ventricle, and non-surgical patients；
Those with obvious neurological dysfunction after the onset, 5≤GCS≤15 or NIHSS≥6；
Admission within 72 hours after the onset of the disease, and no significant enlargement of the hematoma within 24 hours after admission (hematoma enlargement ≤ 5ml)；
The patient/family knows and signs the informed consent form voluntarily.
Exclusion Criteria:
Cerebral hemorrhage caused by cerebral aneurysm, brain tumor, brain trauma, cerebral parasitic disease, cerebrovascular malformation, abnormal blood vessel network at the base of the brain, cerebral arteritis, blood disease, metabolic disorder and other diseases confirmed by examination;
Patients with enlarged hematoma found within 24 hours after admission (the volume of enlarged hematoma> 5ml);
Patients with simple transient ischemic attack, lacunar infarction, subarachnoid hemorrhage and ischemic cerebral infarction;
Patients who use anticoagulant drugs for a long time;
Patients with platelet count <100,000, INR>1.4 at admission and abnormal blood coagulation function;
The measured value of homocysteine at admission is higher than 15μmol/L;
Patients who need surgical treatment (including ventricular drainage);
Patients with severe primary diseases such as cardiovascular, liver (ALT or AST>1.5 times the upper limit of normal), kidneys (BUN>1.5 times the upper limit of normal and Cr>upper limit of normal), endocrine system and hematopoietic system;
Those who are allergic to protein and test drugs;
People who are dependent on drugs or alcohol;
Intended pregnancy or women of childbearing age with positive pregnancy test and lactating women;
Participated in other clinical trials within the past 3 months;
Patients considered by the investigator to be inappropriate to participate in clinical trials.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fu Xudong, PhD
Phone
13733167393
Email
fxd1064@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhou Shaolong, PhD
Phone
13838182963
Email
13838182963@163.com
Facility Information:
Facility Name
The Fifth Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
410103
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fu Xudong, PhD
Phone
13733167393
Email
fxd1064@126.com
First Name & Middle Initial & Last Name & Degree
Zhou Shaolong, PhD
Phone
13838182963
Email
13838182963@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Clinical Study of Huperzine A in the Treatment of Patients With Hypertensive Cerebral Hemorrhage
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