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

NCT ID: NCT00547950

Last Updated: 2007-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ischemic Stroke

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

drug

Group Type EXPERIMENTAL

:Deng Zhan Sheng Mai Capsule

Intervention Type DRUG

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

Interventions

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:Deng Zhan Sheng Mai Capsule

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangzhou University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Principal Investigators

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Yan Huang, Bachelor

Role: PRINCIPAL_INVESTIGATOR

Guangdong Province Hospital of Tradtional Chinese Medicine

Locations

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Guangdong Province Hospital of Tradtional Chinese Medicine

Guangzhou, Guangdong, China

Site Status

Countries

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China

Central Contacts

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Yan Huang, Bachelor

Role: CONTACT

Phone: (08620) 81887233

Email: [email protected]

LIxin Wang, Doctor

Role: CONTACT

Phone: (08620) 81887233

Email: [email protected]

Facility Contacts

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Lixin Wang, Doctor

Role: primary

Other Identifiers

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2006BAI04A02-2

Identifier Type: -

Identifier Source: org_study_id