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

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ClinicalTrials.gov Identifier: NCT01926834
Recruitment Status : Unknown
Verified August 2013 by Guangzhou University of Traditional Chinese Medicine.
Recruitment status was:  Not yet recruiting
First Posted : August 21, 2013
Last Update Posted : August 21, 2013
Sponsor:
Information provided by (Responsible Party):
Guangzhou University of Traditional Chinese Medicine

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.

Condition or disease Intervention/treatment Phase
Cerebral Infarction Drug: Erigeron Injection Drug: placebo Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Erigeron Injection on Acute Cerebral Infarction Serum VEGF, MMP-9 and EPC Levels
Study Start Date : August 2013
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : March 2014

Arm Intervention/treatment
Experimental: Erigeron Injection
Erigeron Injection, 30ml,qd,i.v., for 7 days
Drug: Erigeron Injection
Erigeron Injection, 30ml, iv, qd, for 7days

Placebo Comparator: placebo
normal saline, 500ml,i.v.,qd, for 7 days
Drug: placebo
normal saline, 500ml,i.v.,qd, for 7 days
Other Name: normal saline, 500ml,i.v.,qd, for 7 days

No Intervention: health volunteers
health volunteers, no drug to be given.



Primary Outcome Measures :
  1. the serum level of VEGF,MMP-9 and EPC [ Time Frame: 0-7days ]

Secondary Outcome Measures :
  1. National Institute of Health of stroke scale [ Time Frame: 0-7days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01926834


Contacts
Contact: Jianwen Guo, doctor 0086-13724899379 jianwen_guo@msn.com
Contact: Yefeng Cai, master (08620)81887233 ext 34530 caiyefeng@126.com

Sponsors and Collaborators
Guangzhou University of Traditional Chinese Medicine
Investigators
Principal Investigator: Jianwen m Guo, doctor Guangdong Province Hospital of Tradtional Chinese Medicine

Responsible Party: Guangzhou University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT01926834     History of Changes
Other Study ID Numbers: 1201/01/006284
First Posted: August 21, 2013    Key Record Dates
Last Update Posted: August 21, 2013
Last Verified: August 2013

Keywords provided by Guangzhou University of Traditional Chinese Medicine:
promoting angiogenesis in multiple targets
herbal medicine
traditional chinese medicine
random clinical trial

Additional relevant MeSH terms:
Infarction
Cerebral Infarction
Ischemia
Pathologic Processes
Necrosis
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Stroke
Vascular Diseases
Cardiovascular Diseases