The Secondary Prevention Trial for Ischemic Stroke With DengzhanShengmai Capsule (SPIRITDZSM1)

This study has been completed.

Sponsor:

Collaborators:

Second Affiliated Hospital, School of Medicine, Zhejiang University

Nanhai hospital of TCM

People's hospital of Huizhou city

Taishan city hospital of TCM

Ruijin Hospital

First Affiliated Hospital of Fujian Medical University

Yangjiang City Hospital of TCM in Guangdong Province

Xinxing county hospital of TCM

Southern branch of yuexiu district hospital of TCM

Xinhui hospital of TCM of Jiangmen

Shanghai Pudong New Area People's Hospital

People's hospital of Jianyang city

Luzhou Medical College

Mianyang city hospital of TCM

Guangyuan city hospital of TCM of Sichuan Province

The Third Affiliated Hospital of Guangzhou Medical University

Shunde district hospital of TCM

Shenzhen People's Hospital

Anyue county hospital of TCM

Chengdu Integrated TCM&Western Medicine Hospital

Guagnzhou Red Cross Hospital

Jiangsu Provincial People's Hospital

Ankang hospital of traditional Chinese medicine

Qishan county hospital of shaanxi province

Zongrui hospital of Ningbo city

The First Teaching Hospital of Xinjiang Medical University

Lianyungang Chinese Medicine Hospital

Yufu City Hospital of TCM in Guangdong Province

169 Military Hospital of China

The affiliated hospital of Liaoning University of Traditional Chinese Medicine

The second affiliated hospital of shanxi college of TCM

URUMQI Hospital of Traditional Chinese Medicine

Hubei General Hospital

The People's Hospital of Leshan

Guagnzhou Liwan district Hospital of TCM

Longhua Hospital

Shanghai Jiao Tong University School of Medicine

Hangzhou City Hospital of TCM

Dongguan city hospital of TCM

Liuzhou City hospital of TCM

Maoming city hospital of TCM

Beijing Tiantan Hospital

Nantong University

Xi'an city hospital of TCM

Jiangsu province hospital of TCM

The Third People's Hospital of Chengdu

Huizhou Municipal Central Hospital

Zhejiang Provincial Hospital of TCM

The Second People's Hospital of Yibin

Shanxi provincial people's hospital

The First Affiliated Hospital of Guangzhou Medical University

Ruikang Hospital of Guangxi Traditional Chinese Medical University

Third Affiliated Hospital, Sun Yat-Sen University

First Teaching Hospital of Tianjin University of TCM

Afﬁliated Hospital of North Sichuan Medical College

NO.3 Affiliated Hospital of Henan University of Chinese Medicine

Zhuhai Affiliated Hospital of Guangdong Provincial Hospital of Chinese Medicine

Nanfang Hospital of Southern Medical University

West China School of Medicine West China Hospital,Sichuan University

Guangdong Second Provincial Traditional Chinese Medicine

The First Hospital of Handan City

Anhui Provincial Hospital of Traditional Chinese Medicine

Conghua city hospital of TCM

The First Affiliated Hospital of Guangxi University of Chinese Medicine

Hubei Provincial Hospital of TCM

Jinan city hospital of TCM

Affiliated Hospital of Shaanxi University of Chinese Medicine

Suining People's Hospital

Wuzhou city red cross hospital

Wuhan Interated ＆Western Hospital

Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an city central hospital

Zhengzhou City Hospital of TCM

Xiangya Hospital of Central South University

The Second Affiliated Hospital of Sun Yat-sen University

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

ShuGuang Hospital

Hospital of Traditional Chinese Medicine of Zhongshan

Foshan City Hospital of TCM

Teaching Hospital of Chengdu University of TCM

Jiangmen Wuyi Traditional Chinese Medicine Hospital

Guangdong Provincial Hospital of Traditional Chinese Medicine

Information provided by (Responsible Party):

jianwen guo, MD, Guangzhou University of Traditional Chinese Medicine

ClinicalTrials.gov Identifier:

NCT00548223

First received: October 11, 2007

Last updated: August 5, 2013

Last verified: August 2013

History of Changes

Purpose

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.

Condition	Intervention	Phase
Stroke	Drug: Dengzhan Shengmai capsule Drug: placebo	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

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

Primary Outcome Measures:

recurrence of stroke [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

incidence rate of cardiovascular events, and peripheral arterial events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]


Enrollment:	3143
Study Start Date:	December 2007
Study Completion Date:	January 2011
Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

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
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

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00548223

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Sponsors and Collaborators

Guangzhou University of Traditional Chinese Medicine