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The Effect of Erigeron Injection on Acute Cerebral Infarction Serum VEGF, MMP-9 and EPC Levels

Primary Purpose

Cerebral Infarction

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Erigeron Injection
placebo
Sponsored by
Guangzhou University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Infarction focused on measuring promoting angiogenesis in multiple targets, herbal medicine, traditional chinese medicine, random clinical trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • patients aged no younger than 18yrs
  • attack within 72 hours
  • NIHSS score in the 2-25 points
  • Ischemic Stroke occurred for the first time, or with a history of stroke disease but without sequelae
  • Signed the informed consents

Exclusion Criteria:

  • patients aged younger than 18yrs
  • Patients with tumor, coronary heart disease, valvular heart disease, psoriasis, rheumatism, hematologic diseases, infertility, varieties of acute inflammation
  • Patients with severe cognitive impairment
  • Refused to cooperate or been unable to cooperation for neurological disorders
  • Cerebral hemorrhage or hemorrhagic cerebral infarction
  • Unstable vital signs dued to massive cerebral infarction
  • Patients with serious heart, liver and renal insufficiency

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Placebo Comparator

    No Intervention

    Arm Label

    Erigeron Injection

    placebo

    health volunteers

    Arm Description

    Erigeron Injection, 30ml,qd,i.v., for 7 days

    normal saline, 500ml,i.v.,qd, for 7 days

    health volunteers, no drug to be given.

    Outcomes

    Primary Outcome Measures

    the serum level of VEGF,MMP-9 and EPC

    Secondary Outcome Measures

    National Institute of Health of stroke scale

    Full Information

    First Posted
    August 19, 2013
    Last Updated
    August 19, 2013
    Sponsor
    Guangzhou University of Traditional Chinese Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01926834
    Brief Title
    The Effect of Erigeron Injection on Acute Cerebral Infarction Serum VEGF, MMP-9 and EPC Levels
    Official Title
    The Effect of Erigeron Injection on Acute Cerebral Infarction Serum VEGF, MMP-9 and EPC Levels
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2013
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2013 (undefined)
    Primary Completion Date
    August 2013 (Anticipated)
    Study Completion Date
    March 2014 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Guangzhou University of Traditional Chinese Medicine

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To study the effects of Erigeron Injection on human serum VEGF, MMP-9 and EPC levels after acute cerebral infarction,test is made by random double-blind controlled.patients with acute cerebral infarction were divided randomly into erigeron injection+aspirin group,aspirin group,and health people. The main indexes are the serum level of VEGF, MMP-9 and EPC.The review is made by the reference to NIHSS and so on. So, Erigeron Injection have the function of promoting angiogenesis in multiple targets through this test.
    Detailed Description
    OBJECTIVE: To study the effects of Erigeron Injection on human serum VEGF, MMP-9 and EPC levels after acute cerebral infarction. METHOD: 40 patients with acute cerebral infarction(in accordance with the inclusion criteria) were divided randomly into erigeron injection+aspirin group,aspirin group,and 20 health people. Erigeron injection+aspirin group and aspirin group drew peripheral blood on the prior treatment,the posttreatment 1th, 3th and 7th day,and tested the level of VEGF, MMP-9 and EPC.Tested the health people one time.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebral Infarction
    Keywords
    promoting angiogenesis in multiple targets, herbal medicine, traditional chinese medicine, random clinical trial

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Erigeron Injection
    Arm Type
    Experimental
    Arm Description
    Erigeron Injection, 30ml,qd,i.v., for 7 days
    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Arm Description
    normal saline, 500ml,i.v.,qd, for 7 days
    Arm Title
    health volunteers
    Arm Type
    No Intervention
    Arm Description
    health volunteers, no drug to be given.
    Intervention Type
    Drug
    Intervention Name(s)
    Erigeron Injection
    Intervention Description
    Erigeron Injection, 30ml, iv, qd, for 7days
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Other Intervention Name(s)
    normal saline, 500ml,i.v.,qd, for 7 days
    Intervention Description
    normal saline, 500ml,i.v.,qd, for 7 days
    Primary Outcome Measure Information:
    Title
    the serum level of VEGF,MMP-9 and EPC
    Time Frame
    0-7days
    Secondary Outcome Measure Information:
    Title
    National Institute of Health of stroke scale
    Time Frame
    0-7days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: patients aged no younger than 18yrs attack within 72 hours NIHSS score in the 2-25 points Ischemic Stroke occurred for the first time, or with a history of stroke disease but without sequelae Signed the informed consents Exclusion Criteria: patients aged younger than 18yrs Patients with tumor, coronary heart disease, valvular heart disease, psoriasis, rheumatism, hematologic diseases, infertility, varieties of acute inflammation Patients with severe cognitive impairment Refused to cooperate or been unable to cooperation for neurological disorders Cerebral hemorrhage or hemorrhagic cerebral infarction Unstable vital signs dued to massive cerebral infarction Patients with serious heart, liver and renal insufficiency
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jianwen Guo, doctor
    Phone
    0086-13724899379
    Email
    jianwen_guo@msn.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yefeng Cai, master
    Phone
    (08620)81887233
    Ext
    34530
    Email
    caiyefeng@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jianwen m Guo, doctor
    Organizational Affiliation
    Guangdong Province Hospital of Tradtional Chinese Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    The Effect of Erigeron Injection on Acute Cerebral Infarction Serum VEGF, MMP-9 and EPC Levels

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