The Secondary Prevention Trial for Ischemic Stroke With DengzhanShengmai Capsule

Phase 4

Completed

• Conditions: Stroke
• Interventions: Drug: Dengzhan Shengmai capsule; Drug: placebo

• Registration Number: NCT00548223
• Lead Sponsor: Guangzhou University of Traditional Chinese Medicine

Brief Summary

In order to observe the secondary preventive effect of the Dengzhanshengmai capsule on ischemic stroke, the investigators hold the large randomized control trial (RCT). 3143 subjects are included in 83 clinical research centers all over China. The subjects are randomly grouped into two groups. The basic therapy included antiplatelet aggregation, stroke health education, management of blood pressure, blood lipid and blood glucose, etc. The treating group will take the compound Chinese Medicine Deng Zhan Sheng Mai capsule and the contrast group will take the placebo for twelve months. Then all of the subjects are visited on the 30th, 90th, 180th, 360th day after inclusion. The recurrence of stroke, cardiovascular events, and peripheral arterial events are observed.

Detailed Description

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 Timeline

• Study First Submitted: 2007-10-11
• Study First Submitted QC: 2007-10-22
• Study First Posted: 2007-10-23
• Study Start: 2007-12
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-05
• Last Update Posted: 2013-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3143

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dengzhan Shengmai capsule	Dengzhan Shengmai capsule	Dengzhan Shengmai capsule 0.18g by mouth twice a day for 1year
Placebo	placebo	Placebo 0.18g by mouth twice a day for 1year

Primary Outcome Measures

Name	Time	Method
recurrence of stroke	1 year

Secondary Outcome Measures

Name	Time	Method
incidence rate of cardiovascular events, and peripheral arterial events	1 year

Trial Locations

Locations (84)

Anhui College of Traditional Chinese Medicine First Affiliated Hospital; 🇨🇳 Hefei, Anhui, China

Xuanwu Hospital of Capital University of Medical Sciences; 🇨🇳 Beijing, Beijing, China

First Affiliated Hospital of Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China

Chinese medicine hospital Conghua City; 🇨🇳 Conghua, Guangdong, China

Dongguan City Chinese medicine hospital; 🇨🇳 Dongguan, Guangdong, China

Chinese medicine hospital in Foshan city; 🇨🇳 Foshan, Guangdong, China

Foshan First People's Hospital; 🇨🇳 Foshan, Guangdong, China

Integrated Hospital in Guangdong Province; 🇨🇳 Foshan, Guangdong, China

Foshan Shunde Area Integrated Hospital in Guangdong Province; 🇨🇳 Foshan, Guangdong, China

The second Chinese medicine hospital in Guangdong Province; 🇨🇳 Guangzhou, Guangdong, China

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