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 because the information has not been verified recently.
Verified October 2007 by Guangzhou University of Traditional Chinese Medicine.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Guangzhou University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT00547950
First received: October 22, 2007
Last updated: October 28, 2007
Last verified: October 2007
  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: 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

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00547950     History of Changes
Other Study ID Numbers: 2006BAI04A02-2
Study First Received: October 22, 2007
Last Updated: October 28, 2007
Health Authority: China: Ethics Committee
China: Ministry of Health
China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 01, 2014