Status:
UNKNOWN
Clinical Study of Huperzine A in the Treatment of Patients With Hypertensive Cerebral Hemorrhage
Lead Sponsor:
Jiangsu Famous Medical Technology Co., Ltd.
Conditions:
Neurosensory Disorder
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
1. To evaluate the effectiveness of Huperzine A injection in the treatment of brain injury in patients with hypertensive cerebral hemorrhage； 2. To evaluate the safety of Huperzine A injection in the ...
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 use...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 28 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04509323
Start Date
August 3 2020
End Date
May 28 2021
Last Update
August 12 2020
Active Locations (1)
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1
The Fifth Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 410103