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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)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2007 by Guangzhou University of Traditional Chinese Medicine.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00547950
First Posted: October 23, 2007
Last Update Posted: October 30, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Guangzhou University of Traditional Chinese Medicine
  Purpose
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.

Condition Intervention
Ischemic Stroke Drug: :Deng Zhan Sheng Mai Capsule

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Model Study on the Comprehensive Treating Protocol of Secondary Prevention and Effect Evaluation of Ischemic Stroke With Traditional Chinese Medicine

Resource links provided by NLM:


Further study details as provided by Guangzhou University of Traditional Chinese Medicine:

Primary Outcome Measures:
  • recurrence of stroke [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Cardiovascular events and other peripheral vascular events Modified Rankin Scale (mRS) [ Time Frame: 1 year ]

Estimated Enrollment: 12000
Study Start Date: November 2007
Estimated Study Completion Date: October 2009
Arms Assigned Interventions
Experimental: 1
drug
Drug: :Deng Zhan Sheng Mai Capsule
capsule,0.18g,2#,po,Bid*1year.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00547950


Contacts
Contact: Yan Huang, Bachelor (08620) 81887233 ext 34530 huang61@medmail.com.cn
Contact: LIxin Wang, Doctor (08620) 81887233 ext 34530 plawlx@126.com

Locations
China, Guangdong
Guangdong Province Hospital of Tradtional Chinese Medicine Not yet recruiting
Guangzhou, Guangdong, China, 510120
Contact: Lixin Wang, Doctor    (08620)81887233 ext 34530    plawlx@126.com   
Principal Investigator: Yan Huang, Doctor         
Sponsors and Collaborators
Guangzhou University of Traditional Chinese Medicine
Investigators
Principal Investigator: Yan Huang, Bachelor Guangdong Province Hospital of Tradtional Chinese Medicine
  More Information

ClinicalTrials.gov Identifier: NCT00547950     History of Changes
Other Study ID Numbers: 2006BAI04A02-2
First Submitted: October 22, 2007
First Posted: October 23, 2007
Last Update Posted: October 30, 2007
Last Verified: October 2007

Additional relevant MeSH terms:
Stroke
Ischemia
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia