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

NCT04509323 | Unknown Phase 4

• 1 other identifier: FM-P5-2020020501
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To evaluate the effectiveness of Huperzine A injection in the treatment of brain injury in patients with hypertensive cerebral hemorrhage；
2. 2.To evaluate the safety of Huperzine A injection in the treatment of brain injury in patients with hypertensive cerebral hemorrhage。

Conditions

Neurosensory Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Extension of Glasgow Outcome Scale(GOSE) Scores at 30 days of treatment

  At the 30-day

• Scores of Modified Rankin Scale(mRS) at 14 days of treatment

  At the 14-day

• Scores of Modified Rankin Scale(mRS) at 30 days of treatment

  At the 30-day

• Scores of Modified Rankin Scale(mRS) at 90 days of treatment

  At the 90-day

• Scores of National Institute of Health stroke scale(NIHSS) at 14 days of treatment

  At the 14-day

Study Arms (2)

Experimental：Huperzine A for Injection+Basic treatment

EXPERIMENTAL

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

Control：Basic treatment

NO INTERVENTION

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.

Interventions

Huperzine A for Injection DRUG

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

Experimental：Huperzine A for Injection+Basic treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

The Fifth Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 410103, China

Location

MeSH Terms

Conditions

Sensation Disorders

Interventions

huperzine A; Injections

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Fu Xudong, PhD

CONTACT

13733167393; fxd1064@126.com

Zhou Shaolong, PhD

CONTACT

13838182963; 13838182963@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients with hypertensive basal ganglia cerebral hemorrhage

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: August 12, 2020
• Study Start: August 3, 2020
• Primary Completion: February 28, 2021
• Study Completion: May 28, 2021
• Last Updated: August 12, 2020

Record last verified: 2020-08

Locations

CN (1)