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A Multiple-Centered, Prospective Cohort Study: the Second Prevention Trial for Ischemic Stroke With Deng Zhan Sheng Mai Capsule(SPIRIT-DZSM-2)

A Model Study on the Comprehensive Treating Protocol of Secondary Prevention and Effect Evaluation of Ischemic Stroke With Traditional Chinese Medicine

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00547950
Enrollment
12000
Registered
2007-10-23
Start date
2007-11-30
Completion date
2009-10-31
Last updated
2007-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

Brief 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. 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.

Interventions

DRUG:Deng Zhan Sheng Mai Capsule

capsule,0.18g,2#,po,Bid\*1year.

Sponsors

Guangzhou University of Traditional Chinese Medicine
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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; * 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.

Design outcomes

Primary

MeasureTime frame
recurrence of stroke1 year

Secondary

MeasureTime frame
Cardiovascular events and other peripheral vascular events Modified Rankin Scale (mRS)1 year

Countries

China

Contacts

Primary ContactYan Huang, Bachelor
huang61@medmail.com.cn(08620) 81887233
Backup ContactLIxin Wang, Doctor
plawlx@126.com(08620) 81887233

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026