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

August 9, 2020 updated by: Jiangsu Famous Medical Technology Co., Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 410103
        • The Fifth Affiliated Hospital of Zhengzhou University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Extension of Glasgow Outcome Scale(GOSE) Scores at 90 days of treatment
Time Frame: At the 90-day
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Extension of Glasgow Outcome Scale(GOSE) Scores at 30 days of treatment
Time Frame: At the 30-day
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
Time Frame: At the 14-day
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
Time Frame: At the 30-day
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
Time Frame: At the 90-day
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
Time Frame: At the 14-day
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
Time Frame: At the 30-day
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
Time Frame: At the 90-day
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
Time Frame: At the 14-day
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
Time Frame: At the 30-day
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
Time Frame: At the 90-day
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
Time Frame: At the 90-day
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiangsu Famous Medical Technology Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 3, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 28, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 12, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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