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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01926834
Other study ID # 1201/01/006284
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received August 19, 2013
Last updated August 19, 2013
Start date August 2013
Est. completion date March 2014

Study information

Verified date August 2013
Source Guangzhou University of Traditional Chinese Medicine
Contact Jianwen Guo, doctor
Phone 0086-13724899379
Email jianwen_guo@msn.com
Is FDA regulated No
Health authority China: State Administration of Traditional Chinese Medicine of the People's Republic of China
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date March 2014
Est. primary completion date August 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Erigeron Injection
Erigeron Injection, 30ml, iv, qd, for 7days
placebo
normal saline, 500ml,i.v.,qd, for 7 days

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Guangzhou University of Traditional Chinese Medicine

Outcome

Type Measure Description Time frame Safety issue
Primary the serum level of VEGF,MMP-9 and EPC 0-7days No
Secondary National Institute of Health of stroke scale 0-7days No
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