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

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

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。

Study Overview

• Status: Unknown
• Conditions: Neurosensory Disorder
• Intervention / Treatment: Drug: Huperzine A for Injection

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Fu Xudong, PhD; Phone Number: 13733167393; Email: fxd1064@126.com
• Study Contact Backup: Name: Zhou Shaolong, PhD; Phone Number: 13838182963; Email: 13838182963@163.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 410103
      • The fifth Affiliated Hospital of Zhengzhou University
      • Contact: Fu Xudong, PhD; Phone Number: 13733167393; Email: fxd1064@126.com
      • Contact: Zhou Shaolong, PhD; Phone Number: 13838182963; Email: 13838182963@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental：Huperzine A for Injection+Basic treatment; 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.	Drug: Huperzine A for Injection; Give the patient one intramuscular injection (0.2mg) of Huperzine A of injection once a day for 14 days
NO_INTERVENTION: Control：Basic treatment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Jiangsu Famous Medical Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 3, 2020
• Primary Completion (ANTICIPATED): February 28, 2021
• Study Completion (ANTICIPATED): May 28, 2021

Study Registration Dates

• First Submitted: July 22, 2020
• First Submitted That Met QC Criteria: August 9, 2020
• First Posted (ACTUAL): August 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 12, 2020
• Last Update Submitted That Met QC Criteria: August 9, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage; Intracranial Hemorrhage, Hypertensive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Enzyme Inhibitors; Neuroprotective Agents; Protective Agents; Cholinesterase Inhibitors; Huperzine A
• Other Study ID Numbers: FM-P5-2020020501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No