The Secondary Prevention Trial for Ischemic Stroke With DengzhanShengmai Capsule (SPIRITDZSM1)
![]() |
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. |
ClinicalTrials.gov Identifier: NCT00548223 |
Recruitment Status :
Completed
First Posted : October 23, 2007
Last Update Posted : August 7, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Stroke | Drug: Dengzhan Shengmai capsule Drug: placebo | Phase 4 |
Objective:To observe the secondary clinical effect of the Deng Zhan Sheng Mai capsule on ischemic stroke patients.
Methods:3143 subjects suffering from acute ischemic stroke are included in 83 clinical research centers all over China. The subjects are randomly divided into two groups:The treating group and the placebo group.Both groups accept the basic therapy and test drug.The basic therapy included antiplatelet aggregation,stroke health education,management of blood pressure,blood lipid and blood glucose,etc.The patients in Dengzhan Shengmaigroup take Deng Zhan Sheng Mai capsule and the placebo group take the placebo drug for twelve months.Then all of the subjects are visited on the 30th,90th,180th,360th day after inclusion. Primary endpoints(cerebral infarction,intracerebral hemorrhage,subarachnoid hemorrhage) and secondary endpoints(cardiovascular events,peripheral arterial disease),functional disability are observed at each follow up.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 3143 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Model Study on the Comprehensive Treating Protocol and Effect Evaluation of Ischemic Stroke With Traditional Chinese Medicine |
Study Start Date : | December 2007 |
Actual Primary Completion Date : | January 2011 |
Actual Study Completion Date : | January 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: Dengzhan Shengmai capsule
Dengzhan Shengmai capsule 0.18g by mouth twice a day for 1year
|
Drug: Dengzhan Shengmai capsule
Capsule, 0.18g, 2#, Bid*1year
Other Name: DZSM |
Placebo Comparator: Placebo
Placebo 0.18g by mouth twice a day for 1year
|
Drug: placebo
Capsule, 0.18g, 2#, Bid*1year
Other Name: DZSMP |
- recurrence of stroke [ Time Frame: 1 year ]
- incidence rate of cardiovascular events, and peripheral arterial events [ Time Frame: 1 year ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 40 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | 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:
- Silent cerebral infarction
- Cerebral infarction due to other causes except artery scleroses (i.e. cardiogenic embolism, hypercoagulable state, endangium stripping, vasculitis)
- Presence of serious heart disease, heart, liver, lung, and kidney functional failure; malignancy; alimentary tract hemorrhage mental disorder and noncooperation with physician
- Females during pregnancy or lactation
- Already attend other clinical trial

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): NCT00548223

Principal Investigator: | Yan Huang, Bachelor | Guangdong Provincial Hospital of Tradtional Chinese Medicine |
Responsible Party: | jianwen guo, MD, Professor, Guangzhou University of Traditional Chinese Medicine |
ClinicalTrials.gov Identifier: | NCT00548223 |
Other Study ID Numbers: |
2006BAI04A02 2006BAI04A02 ( Other Grant/Funding Number: "Eleventh Five" program of China ) |
First Posted: | October 23, 2007 Key Record Dates |
Last Update Posted: | August 7, 2013 |
Last Verified: | August 2013 |
recurrence of stroke Dengzhan Shengmai Capsule Traditional Chinese Medicine |
Stroke Ischemic Stroke Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |