NCT01926834

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2013

Shorter than P25 for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

August 19, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

August 21, 2013

Status Verified

August 1, 2013

Enrollment Period

Same day

First QC Date

August 19, 2013

Last Update Submit

August 19, 2013

Conditions

Keywords

promoting angiogenesis in multiple targetsherbal medicinetraditional chinese medicinerandom clinical trial

Outcome Measures

Primary Outcomes (1)

  • the serum level of VEGF,MMP-9 and EPC

    0-7days

Secondary Outcomes (1)

  • National Institute of Health of stroke scale

    0-7days

Study Arms (3)

Erigeron Injection

EXPERIMENTAL

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

Drug: Erigeron Injection

placebo

PLACEBO COMPARATOR

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

Drug: placebo

health volunteers

NO INTERVENTION

health volunteers, no drug to be given.

Interventions

Erigeron Injection, 30ml, iv, qd, for 7days

Erigeron Injection

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

Also known as: normal saline, 500ml,i.v.,qd, for 7 days
placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cerebral Infarction

Interventions

Saline SolutionWW Domain-Containing Oxidoreductase

Condition Hierarchy (Ancestors)

Brain InfarctionBrain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesStrokeVascular DiseasesCardiovascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsShort Chain Dehydrogenase-ReductasesNAD (+) and NADP (+) Dependent Alcohol OxidoreductasesAlcohol OxidoreductasesOxidoreductasesEnzymesEnzymes and CoenzymesTumor Suppressor ProteinsNeoplasm ProteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Jianwen m Guo, doctor

    Guangdong Province Hospital of Tradtional Chinese Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianwen Guo, doctor

CONTACT

Yefeng Cai, master

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2013

First Posted

August 21, 2013

Study Start

August 1, 2013

Primary Completion

August 1, 2013

Study Completion

March 1, 2014

Last Updated

August 21, 2013

Record last verified: 2013-08