Ischemic StrokeNCT00547950
A Multiple-Centered, Prospective Cohort Study: the Second Prevention Trial for Ischemic Stroke With Deng Zhan Sheng Mai Capsule（SPIRIT-DZSM-2）
A study testing :Deng Zhan Sheng Mai Capsule in people with Ischemic Stroke, run by Guangzhou University of Traditional Chinese Medicine at 1 site in China.
Trial summary
In order to observe the influence of the Dengzhan Shengmai Capsule on the endpoint of patients with ischemic stroke, we hold the multi-centered prospective cohort study. From November 2007 to December 2009, 12000 subjects are included in 200 clinical research centers all over China. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- :Deng Zhan Sheng Mai Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,000 participants
- Where
- 1 siteChina
- Study dates
- Nov 2007to Oct 2009
- Phase
- Interventional
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40-75 years old
- Ischemic stroke diagnosed by CT/MRI scan
- Patient presenting from 14 days to 6 months of first onset of Ischemic stroke.
- Presence of at least one risk factor of stroke (such as hypertension, Diabetes mellitus, coronary heart disease, hyperlipidemia, and smoking, etc.)that can be interfered in.
- Informed consent.
Who cannot join
- Silent cerebral infarction;
- Patients after vasculoplasty with Intracranial Artery Stenosis.
- Watian drinking test≥grade 4.
- MRS=grade 5.
- Cerebral infarction due to other causes except arterial Sclerosis(i.e. cardiogenic embolism, arteritis, polycythemia vera, primary thrombocythemia, sickle-cell anemia,, thrombotic thrombocytopenia purpura, DIC, cerebral amyloid angiopathy, Moyamoya disease, intracranial vascular malformations etc);
- Presence of serious heart disease, heart, liver, lung, and kidney functional failure; malignancy; alimentary tract hemorrhage;
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- Patients with mental disorder.
- Patients that cannot take medicine due to other causes
- Females during pregnancy or lactation.
- Already attend other clinical trial.
- That unsuitable for clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Guangdong Province Hospital of Tradtional Chinese Medicine
Guangzhou, Guangdong, 510120
Lixin Wang, Doctor, (08620)81887233 ext. 34530, plawlx@126.com
Yan Huang, Doctor
About this study
Official title: A Model Study on the Comprehensive Treating Protocol of Secondary Prevention and Effect Evaluation of Ischemic Stroke With Traditional Chinese Medicine
In order to observe the influence of the Dengzhan Shengmai Capsule on the endpoint of patients with ischemic stroke, we hold the multi-centered prospective cohort study. From November 2007 to December 2009, 12000 subjects are included in 200 clinical research centers all over China. The subjects naturally formed two cohorts based on taking Dengzhan Shengmai capsule or not. The basic therapy included antiplatelet aggregation , stroke health education, management of blood pressure, blood lipid and blood glucose, etc. Then all of the subjects are visited on the 360th day after inclusion. The recurrence of stroke, cardiovascular events, and peripheral arterial events are observed.
- Conditions
- Ischemic Stroke
- Being tested
- :Deng Zhan Sheng Mai Capsule
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
:Deng Zhan Sheng Mai CapsuleDrug
capsule，0.18g，2＃，po，Bid*1year.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | drug Receives: Drug: :Deng Zhan Sheng Mai Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence of stroke
Measured: 1 year
Secondary outcomes (1)
Cardiovascular events and other peripheral vascular events Modified Rankin Scale (mRS)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2007 (estimated)
- Study startNov 2007
- Study completionOct 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Yan Huang, Bachelor, Principal investigator, Guangdong Province Hospital of Tradtional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00547950
- Sponsor's protocol ID
- 2006BAI04A02-2
- Status last verified
- Oct 2007
- First submitted
- 22 Oct 2007
- Last updated
- 30 Oct 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Model Study on the Comprehensive Treating Protocol of Secondary Prevention and Effect Evaluation of Ischemic Stroke With Traditional Chinese Medicine
- ClinicalTrials.gov ID
- NCT00547950
- Acronym / sponsor ID
- 2006BAI04A02-2
- Conditions
- Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12,000 participants (estimated)
- Lead sponsor
- Guangzhou University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Nov 2007
- Study completion
- Oct 2009 (estimated)
- First posted
- 23 Oct 2007 (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.
In order to observe the influence of the Dengzhan Shengmai Capsule on the endpoint of patients with ischemic stroke, we hold the multi-centered prospective cohort study. From November 2007 to December 2009, 12000 subjects are included in 200 clinical research centers all over China. The subjects naturally formed two cohorts based on taking Dengzhan Shengmai capsule or not. The basic therapy included antiplatelet aggregation , stroke health education, management of blood pressure, blood lipid and blood glucose, etc. Then all of the subjects are visited on the 360th day after inclusion. The recurrence of stroke, cardiovascular events, and peripheral arterial events are observed.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: :Deng Zhan Sheng Mai Capsuledrug |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 40-75 years old
- Ischemic stroke diagnosed by CT/MRI scan
- Patient presenting from 14 days to 6 months of first onset of Ischemic stroke.
- Presence of at least one risk factor of stroke (such as hypertension, Diabetes mellitus, coronary heart disease, hyperlipidemia, and smoking, etc.)that can be interfered in.
- Informed consent.
Key exclusion criteria (11 listed)
- Silent cerebral infarction;
- Patients after vasculoplasty with Intracranial Artery Stenosis.
- Watian drinking test≥grade 4.
- MRS=grade 5.
- Cerebral infarction due to other causes except arterial Sclerosis(i.e. cardiogenic embolism, arteritis, polycythemia vera, primary thrombocythemia, sickle-cell anemia,, thrombotic thrombocytopenia purpura, DIC, cerebral amyloid angiopathy, Moyamoya disease, intracranial vascular malformations etc);
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 |
|---|---|---|
| :Deng Zhan Sheng Mai Capsulecapsule，0.18g，2＃，po，Bid*1year. | Drug | 1 |
Primary outcome
recurrence of stroke
Time frame: 1 year
1 secondary outcome
Cardiovascular events and other peripheral vascular events Modified Rankin Scale (mRS)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2007.
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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.
Yan Huang, Bachelor principal investigator
Guangdong Province Hospital of Tradtional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing :Deng Zhan Sheng Mai Capsule in people with Ischemic Stroke, run by Guangzhou University of Traditional Chinese Medicine at 1 site in China.
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 11 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 30 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Yan Huang, Bachelor ((08620) 81887233 ext. 34530, huang61@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence of stroke (time frame: 1 year). 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 30 Oct 2007.