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NCT Number: NCT00548223

The Secondary Prevention Trial for Ischemic Stroke With DengzhanShengmai Capsule

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dengzhan Shengmai capsule

Drug

Capsule, 0.18g, 2#, Bid*1year

Other names: DZSM

Placebo

Drug

Capsule, 0.18g, 2#, Bid*1year

Other names: DZSMP

Primary outcomes

  1. recurrence of stroke

    Time frame: 1 year

Secondary outcomes

  1. incidence rate of cardiovascular events, and peripheral arterial events

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Guangzhou University of Traditional Chinese Medicine

Other

Collaborators

  • 169 Military Hospital of China
  • Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
  • Affiliated Hospital of Nantong University
  • Affiliated Hospital of North Sichuan Medical College
  • Ankang Hospital of Traditional Chinese Medicine
  • Anyue County Hospital of Traditional Chinese
  • Beijing Tiantan Hospital
  • Chengdu Integrated TCM&Western Medicine Hospital
  • Conghua city hospital of TCM
  • Dongguan city hospital of TCM
  • First Affiliated Hospital of Fujian Medical University
  • First Affiliated Hospital of Guangxi Medical University
  • First Affiliated Hospital of Xinjiang Medical University
  • First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
  • Foshan Hospital of Traditional Chinese Medicine
  • Guagnzhou Liwan district Hospital of TCM
  • Guangdong Provincial Hospital of Traditional Chinese Medicine
  • Guangdong Second Provincial Traditional Chinese Medicine Hospital
  • Guangxi Ruikang Hospital
  • Guangyuan city hospital of TCM of Sichuan Province
  • Guangzhou Red Cross Hospital
  • Handan First Hospital
  • Hangzhou City Hospital of TCM
  • Hubei General Hospital
  • Hubei Hospital of Traditional Chinese Medicine
  • Huizhou Municipal Central Hospital
  • Jiangmen Wuyi Hospital of Traditional Chinese Medicine
  • Jiangsu Provincial People's Hospital
  • Jiangsu province hospital of TCM
  • Jinan city hospital of TCM
  • Lianyungang Chinese Medicine Hospital
  • Liuzhou City hospital of TCM
  • Longhua Hospital
  • Luzhou Medical College
  • Maoming city hospital of TCM
  • Mianyang city hospital of TCM
  • Nanfang Hospital, Southern Medical University
  • Nanhai Hospital of Traditional Chinese Medicine
  • People's hospital of Huizhou city
  • People's hospital of Jianyang city
  • Qishan county hospital of shaanxi province
  • Ruijin Hospital
  • Second Affiliated Hospital of Xi'an Jiaotong University
  • Second Affiliated Hospital, School of Medicine, Zhejiang University
  • Second Affiliated Hospital, Sun Yat-Sen University
  • Shaanxi Hospital of Traditional Chinese Medicine
  • Shanghai Jiao Tong University School of Medicine
  • Shanghai Pudong New Area People's Hospital
  • Shanxi Provincial People's Hospital
  • Shenzhen People's Hospital
  • ShuGuang Hospital
  • Shunde district hospital of TCM
  • Southern branch of yuexiu district hospital of TCM
  • Suining People's Hospital
  • Taishan city hospital of TCM
  • Teaching Hospital of Chengdu University of TCM
  • The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
  • The First Affiliated Hospital of Guangzhou Medical University
  • The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
  • The People's Hospital of Leshan
  • The Second People's Hospital of Yibin
  • The Third Affiliated Hospital of Guangzhou Medical University
  • The Third People's Hospital of Chengdu
  • The second affiliated hospital of shanxi college of TCM
  • Third Affiliated Hospital of Henan University of Traditional Chinese Medicine
  • Third Affiliated Hospital, Sun Yat-Sen University
  • URUMQI Hospital of Traditional Chinese Medicine
  • West China Hospital
  • Wuhan Interated ＆Western Hospital
  • Wuzhou Red Cross Hospital
  • Xi'an Central Hospital
  • Xi'an city hospital of TCM
  • Xiangya Hospital of Central South University
  • Xinhui hospital of TCM of Jiangmen
  • Xinxing county hospital of TCM
  • Yangjiang City Hospital of TCM in Guangdong Province
  • Yufu City Hospital of TCM in Guangdong Province
  • Zhejiang Provincial Hospital of TCM
  • Zhengzhou City Hospital of Traditional Chinese Medicine
  • Zhongshan Hospital Of Traditional Chinese Medicine
  • ZhuHai Hospital
  • Zongrui Hospital

Registry information

Official study title

Model Study on the Comprehensive Treating Protocol and Effect Evaluation of Ischemic Stroke With Traditional Chinese Medicine

Acronym: SPIRITDZSM1

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Oct 23, 2007
Registry last updated
Aug 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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