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

Neurosensory Disorder Clinical Trial

Official title:

A Randomized, Controlled, Single-center Clinical Study of Huperzine A in the Treatment of Brain Injury in Patients With Hypertensive Cerebral Hemorrhage

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04509323
• Other study ID #: FM-P5-2020020501
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: August 3, 2020
• Est. completion date: May 28, 2021

Study information

• Verified date: August 2020
• Source: Jiangsu Famous Medical Technology Co., Ltd.
• Contact: Fu Xudong, PhD
• Phone: 13733167393
• Email: fxd1064[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 treatment of brain injury in patients with hypertensive cerebral hemorrhage。

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: May 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracranial Hemorrhage, Hypertensive
• Neurosensory Disorder

Intervention

Drug:
• Huperzine A for Injection
Give the patient one intramuscular injection (0.2mg) of Huperzine A of injection once a day for 14 days

Locations

Country	Name	City	State
China	The Fifth Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Famous Medical Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At the 90-day
Secondary	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.	At the 30-day
Secondary	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.	At the 14-day
Secondary	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.	At the 30-day
Secondary	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.	At the 90-day
Secondary	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.	At the 14-day
Secondary	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.	At the 30-day
Secondary	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.	At the 90-day
Secondary	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.	At the 14-day
Secondary	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.	At the 30-day
Secondary	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.	At the 90-day
Secondary	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	At the 90-day