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Status unknownNCT00547950Updated Oct 30, 2007

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

An interventional study of :Deng Zhan Sheng Mai Capsule in Ischemic Stroke, sponsored by Guangzhou University of Traditional Chinese Medicine. Status unknown at 1 site in China. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2007-10-30.

Sponsored by Guangzhou University of Traditional Chinese Medicine · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Oct 2007), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
12,000
Allocation
Non-randomized
Ages
40 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Ischemic Stroke
03

In context

Stroke

7,283 studies on the registry are indexed under Stroke; 2,013 are open to participants now.

This study's planned enrollment of 12,000 is above the median of 50 across 5,366 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Guangzhou University of Traditional Chinese Medicine is the lead sponsor of 57 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
12,000 participants (estimated)

Study arms

  • Experimental
    1

    drug

    Drug: :Deng Zhan Sheng Mai Capsule

Interventions

  • Drug:Deng Zhan Sheng Mai Capsule

    capsule，0.18g，2＃，po，Bid\*1year.

06

What researchers measure

Primary outcomes

  1. recurrence of stroke

    Time frame: 1 year

Secondary outcomes

  1. Cardiovascular events and other peripheral vascular events Modified Rankin Scale (mRS)

    Time frame: 1 year

07

Study locations

1 site
  • Guangdong Province Hospital of Tradtional Chinese Medicine
    Guangzhou, Guangdong 510120, China
    • Lixin Wang, Doctor · Contact · plawlx@126.com · (08620)81887233
    • Yan Huang, Doctor · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 30, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00547950
Lead sponsor
Guangzhou University of Traditional Chinese Medicine
First posted
Oct 23, 2007
Start date
Nov 2007
Completion
Oct 2009 (estimated)
Last update
Oct 30, 2007

Study contacts

Yan Huang, Bachelor
Contact
huang61@medmail.com.cn
(08620) 81887233 ext. 34530
LIxin Wang, Doctor
Contact
plawlx@126.com
(08620) 81887233 ext. 34530
Yan Huang, Bachelor
principal investigator · Guangdong Province Hospital of Tradtional Chinese Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2007. You cannot join it, but the record below documents what was studied.

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