Cerebral InfarctionPhase 4NCT01926834
The Effect of Erigeron Injection on Acute Cerebral Infarction Serum VEGF, MMP-9 and EPC Levels
A Phase 4 study testing Erigeron Injection in people with Cerebral Infarction, run by Guangzhou University of Traditional Chinese Medicine.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cerebral Infarction
- What is being tested?
- Erigeron Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2013to Mar 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Cerebral Infarction
- Being tested
- Erigeron Injection, placebo
- Keywords
- promoting angiogenesis in multiple targets, herbal medicine, traditional chinese medicine, random clinical trial
- Medical subject headings
- Cerebral Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erigeron InjectionDrug
Erigeron Injection, 30ml, iv, qd, for 7days
placeboDrug
Also called normal saline, 500ml,i.v.,qd, for 7 days
normal saline, 500ml,i.v.,qd, for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Erigeron Injection | Experimental | Erigeron Injection, 30ml,qd,i.v., for 7 days Receives: Drug: Erigeron Injection |
| placebo | Placebo comparator | normal saline, 500ml,i.v.,qd, for 7 days Receives: Drug: placebo |
| health volunteers | No intervention | health volunteers, no drug to be given. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the serum level of VEGF,MMP-9 and EPC
Measured: 0-7days
Secondary outcomes (1)
National Institute of Health of stroke scale
Measured: 0-7days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2013 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianwen m Guo, doctor, Principal investigator, Guangdong Province Hospital of Tradtional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01926834
- Sponsor's protocol ID
- 1201/01/006284
- Status last verified
- Aug 2013
- First submitted
- 19 Aug 2013
- Last updated
- 21 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Erigeron Injection on Acute Cerebral Infarction Serum VEGF, MMP-9 and EPC Levels
- ClinicalTrials.gov ID
- NCT01926834
- Acronym / sponsor ID
- 1201/01/006284
- Conditions
- Cerebral Infarction
- Keywords
- promoting angiogenesis in multiple targets, herbal medicine, traditional chinese medicine, random clinical trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Guangzhou University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 21 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Erigeron Injection | Experimental | Drug: Erigeron InjectionErigeron Injection, 30ml,qd,i.v., for 7 days |
| placebo | Placebo comparator | Drug: placebonormal saline, 500ml,i.v.,qd, for 7 days |
| health volunteers | No intervention | –health volunteers, no drug to be given. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erigeron InjectionErigeron Injection, 30ml, iv, qd, for 7days | Drug | Erigeron Injection |
| placeboAlso: normal saline, 500ml,i.v.,qd, for 7 daysnormal saline, 500ml,i.v.,qd, for 7 days | Drug | placebo |
Primary outcome
the serum level of VEGF,MMP-9 and EPC
Time frame: 0-7days
1 secondary outcome
National Institute of Health of stroke scale
Time frame: 0-7days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianwen m Guo, doctor principal investigator
Guangdong Province Hospital of Tradtional Chinese Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Erigeron Injection in people with Cerebral Infarction, run by Guangzhou University of Traditional Chinese Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianwen Guo, doctor (0086-13724899379, jianwen_guo@msn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the serum level of VEGF,MMP-9 and EPC (time frame: 0-7days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2013.