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 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
  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
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: NCT00548223

  Show 84 Study Locations
Sponsors and Collaborators
Guangzhou University of Traditional Chinese Medicine
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 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
Investigators
Principal Investigator: Yan Huang, Bachelor Guangdong Provincial Hospital of Tradtional Chinese Medicine
  More Information

No publications provided

Responsible Party: jianwen guo, MD, Professor, Guangzhou University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT00548223     History of Changes
Other Study ID Numbers: 2006BAI04A02, 2006BAI04A02
Study First Received: October 11, 2007
Last Updated: August 5, 2013
Health Authority: China: The China Academy of Chinese Medical Sciences
China: Food and Drug Administration

Keywords provided by Guangzhou University of Traditional Chinese Medicine:
recurrence of stroke
Dengzhan Shengmai Capsule
Traditional Chinese Medicine

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
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 September 18, 2014