Clinical Study of Huperzine A in the Treatment of Patients With Hypertensive Cerebral Hemorrhage

Jiangsu Famous Medical Technology

Status and phase: Unknown; Phase 4

Conditions: Neurosensory Disorder

Treatments: Drug: Huperzine A for Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT04509323

FM-P5-2020020501

Details and patient eligibility

About

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 treatment of brain injury in patients with hypertensive cerebral hemorrhage。

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged from 18 to 75 years old(including 18 and 75 years old), males or females;
2. 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；
3. Those with obvious neurological dysfunction after the onset, 5≤GCS≤15 or NIHSS≥6；
4. 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)；
5. The patient/family knows and signs the informed consent form voluntarily.

Exclusion criteria

1. 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;
2. Patients with enlarged hematoma found within 24 hours after admission (the volume of enlarged hematoma> 5ml);
3. Patients with simple transient ischemic attack, lacunar infarction, subarachnoid hemorrhage and ischemic cerebral infarction;
4. Patients who use anticoagulant drugs for a long time;
5. Patients with platelet count <100,000, INR>1.4 at admission and abnormal blood coagulation function;
6. The measured value of homocysteine at admission is higher than 15μmol/L;
7. Patients who need surgical treatment (including ventricular drainage);
8. 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;
9. Those who are allergic to protein and test drugs;
10. People who are dependent on drugs or alcohol;
11. Intended pregnancy or women of childbearing age with positive pregnancy test and lactating women;
12. Participated in other clinical trials within the past 3 months;
13. Patients considered by the investigator to be inappropriate to participate in clinical trials.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Experimental：Huperzine A for Injection+Basic treatment

Experimental group

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.

Treatment:

Drug: Huperzine A for Injection

Control：Basic treatment

No Intervention group

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.