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StrokePhase 4SPIRITDZSM1NCT00548223

The Secondary Prevention Trial for Ischemic Stroke With DengzhanShengmai Capsule

A Phase 4 study testing Dengzhan Shengmai capsule in people with Stroke, run by Guangzhou University of Traditional Chinese Medicine at 84 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Stroke
What is being tested?
Dengzhan Shengmai capsule
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3,143 participants
Where
84 sitesChina
Study dates
Dec 2007to Jan 2011
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

84 sites in 1 country.

84 sites in 1 country

China84 sites

  • Ankang Hospital of TCM in Shanxi Province

    Ankang, Shanxi, 725000

  • Xuanwu Hospital of Capital University of Medical Sciences

    Beijing, Beijing Municipality, 10053

  • Tiantan Hospital Capital University of Medical Sciences

    Beijing, 100050

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410008

  • Chengdu Integrated Hospital

    Chengdu, Sichuan, 610016

  • The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

    Chengdu, Sichuan, 610036

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

  • People's Hospital of Sichuan Province

    Chengdu, Sichuan, 610072

  • The 2nd People Hospital of Chengdu City

    Chengdu, Sichuan, 621000

  • The Second Affiliated Hospital of Chongqing Third Military Medical University

    Chongqing, 400037

  • Dongguan City Chinese medicine hospital

    Dongguan, Guangdong, 523005

  • Chinese medicine hospital in Foshan city

    Foshan, Guangdong, 528000

  • Foshan First People's Hospital

    Foshan, Guangdong, 528000

  • Integrated Hospital in Guangdong Province

    Foshan, Guangdong, 528200

  • Foshan Shunde Area Integrated Hospital in Guangdong Province

    Foshan, Guangdong, 528333

  • First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350005

  • Guangyuan Hospital of TCM in Sichuan Province

    Guangyuan, Sichuan, 628000

  • The second Chinese medicine hospital in Guangdong Province

    Guangzhou, Guangdong, 510095

  • Guangdong Province Hospital of Tradtional Chinese Medicine

    Guangzhou, Guangdong, 510120

  • Second Affiliated Hospital of Zhongshan University

    Guangzhou, Guangdong, 510120

  • The First Affiliated Hospital of Guangzhou Medical College

    Guangzhou, Guangdong, 510120

  • Yuexiu area Hospital of TCM in Guangzhou

    Guangzhou, Guangdong, 510120

  • Chinese medicine hospital in Liwan District of Guangzhou City

    Guangzhou, Guangdong, 510140

  • Third Affiliated Hospital of Guangzhou Medical College

    Guangzhou, Guangdong, 510150

  • Guangzhou Red Cross Hospital

    Guangzhou, Guangdong, 510220

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong, 510515

  • Third Affiliated Hospital of Zhongshan University

    Guangzhou, Guangdong, 510630

  • First Hospital of Handan City, Hebei Province

    Handan, Hebei, 56002

  • The First Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine

    Hangzhou, Zhejiang, 310006

  • Zhejiang University School of Medicine Second Affiliated Hospital

    Hangzhou, Zhejiang, 313000

  • Chinese medicine hospital in Hangzhou

    Hangzhou, Zhejiang

  • Anhui College of Traditional Chinese Medicine First Affiliated Hospital

    Hefei, Anhui, 230031

  • Hengyang Central Hospital

    Hengyang, Hunan, 421001

  • The 169th Hospital of PLA

    Hengyang, Hunan, 421002

  • People's Hospital of Huizhou City Center

    Huizhou, Guangdong, 516001

  • Huizhou People Hospital in Guangdong Province

    Huizhou, Guangdong, 516002

  • Jianyang Hospital of TCM in Sichuang Province

    Jiancheng, Sichuan, 641400

  • Jiangmen Wuyi Chinese medicine hospital

    Jiangmen, Guangdong, 529000

  • Chinese medicine hospital Conghua City

    Jiekou, Guangdong, 5109000

  • Chinese Medicine Hospital of Jinan City

    Jinan, Shandong, 250011

  • Leshan City People's Hospital

    Leshan, Sichuan, 614000

  • Lianyungang Hospital of TCM in Jiangsu Province

    Lianyungang, Jiangsu, 222004

  • Liuzhou Hospital of TCM in Guangxi

    Liuzhou, Guangxi, 545001

  • Affiliated Hospital of Luzhou Medical College

    Luzhou, Sichuan, 646000

  • The Affiliated Hospital of TCM of Luzhou Medical School

    Luzhou, Sichuan, 646000

  • Chinese medicine hospital in Maoming City

    Maoming, Guangdong, 525000

  • Mianyang Hospital of TCM in Sichuan Province

    Mianyang, Sichuan, 621000

  • Affiliated Hospital of North Sichuan Medical College

    Nanchong, Sichuan, 637000

  • Chinese medicine hospital in Jiangsu Province

    Nanjing, Jiangsu, 210029

  • Jiangsu Provincial People's Hospital

    Nanjing, Jiangsu, 210029

  • Ruikang Hospital Guangxi College of Traditional Chinese Medicine

    Nanning, Guangxi, 530011

  • First Affiliated Hospital of Guangxi College of Traditional Chinese Medicine

    Nanning, Guangxi, 530023

  • Affiliated Hospital of Nantong University

    Nantong, Jiangxi, 226001

  • Ningbo City, Zhejiang Province zhongRui hospital

    Ningbo, Zhejiang, 315806

  • Qishan Hospital in Shanxi Province

    Qishan, Shanxi, 722400

  • Subsidiary of Shanghai University of Traditional Chinese Medicine, Longhua Hospital

    Shanghai, Shanghai Municipality, 200032

  • Pudong New Area People Hospital in Shanghai

    Shanghai, Shanghai Municipality, 201200

  • Medical College of Shanghai Jiaotong University Yan Chai Hospital

    Shanghai, 200001

  • Shanghai Jiaotong University Medical College Ruijin Hospital

    Shanghai, 200025

  • Subsidiary of Shanghai University of Traditional Chinese Medicine ,Shuguang Hospital

    Shanghai, 200032

  • Liaoning University of Traditional Chinese Medicine Affiliated Hospital

    Shenyang, Liaoning, 110032

  • Shenzhen City People's Hospital

    Shenzhen, Guangdong

  • Taishan Hospital of TCM in Guangdong Province

    Taishan, Guangdong, 529200

  • The 2nd affiliated Hospital fo Shanxi college of TCM

    Taiyuan, Shanxi, 030024

  • Wulumuqi Hospital of TCM

    Ürümqi, Xinjiang, 830000

  • Xinjiang Medical University Affiliated Hospital of First Clinical

    Ürümqi, Xinjiang, 830054

  • Chinese medicine hospital in Hubei Province

    Wuhan, Hubei, 430006

  • First Hospital of Wuhan City

    Wuhan, Hubei, 430022

  • Wuhan University People's Hospital

    Wuhan, Hubei, 430060

  • Guangxi Wuzhou Red Cross Hospital

    Wuzhou, Guangxi, 543002

  • Chinese medicine hospital in Xi'an

    Xi’an, Shanxi, 710001

  • Xi'an Central Hospital

    Xi’an, Shanxi, 710001

  • Shaanxi Provincial People's Hospital

    Xi’an, Shanxi, 710068

  • The Second Affiliated Hospital of Xi'an Jiaotong University Medical College

    Xi’an, Shanxi

  • Affiliated Hospital of Shaanxi College of Traditional Chinese Medicine

    Xianyang, Shanxi, 712000

  • Xinhui Hospital of TCM in Guangdong Province

    Xinhui District, Guangdong, 529100

  • Yangjiang Hospital of TCM in Guangdong Province

    Yangjiang, Guangdong, 529500

  • Anyue Hospital of TCM in Sichuan Province

    Yueyang, Sichuan, 642350

  • Xinxing Hospitla of TCM in Guangdong Province

    Yunfu, Guangdong, 527400

  • The First Affiliated Hospital of Henan College of Traditional Chinese Medicine

    Zhengzhou, Henan, 450000

  • Chinese medicine hospital in Zhengzhou City in Henan Province

    Zhengzhou, Henan, 450007

  • Henan Province, the Third Affiliated Hospital of College of Traditional Chinese Medicine

    Zhengzhou, Henan, 450008

  • Chinese medicine hospital in Zhongshan City, Guangdong Province

    Zhongshan, Guangdong, 528400

  • Chinese medicine hospital in Zhuhai, Guangdong Province Hospital

    Zhuhai, Guangdong, 519015

Other trials in China

About this study

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

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.

Read the 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.

Conditions
Stroke
Being tested
Dengzhan Shengmai capsule, placebo
Keywords
recurrence of stroke, Dengzhan Shengmai Capsule, Traditional Chinese Medicine
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dengzhan Shengmai capsuleDrug

    Also called DZSM

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

  • placeboDrug

    Also called DZSMP

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

Study groups in NCT00548223
Study groupRoleWhat they receive
Dengzhan Shengmai capsuleExperimentalDengzhan Shengmai capsule 0.18g by mouth twice a day for 1year
Receives: Drug: Dengzhan Shengmai capsule
PlaceboPlacebo comparatorPlacebo 0.18g by mouth twice a day for 1year
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. recurrence of stroke

    Measured: 1 year

Secondary outcomes (1)

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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2007 (estimated)
  2. Study startDec 2007
  3. Primary completionJan 2011
  4. Study completionJan 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
3,143 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00548223
Sponsor's protocol ID
2006BAI04A02
Other IDs
2006BAI04A02
Acronym
SPIRITDZSM1
Status last verified
Aug 2013
First submitted
11 Oct 2007
Last updated
7 Aug 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dengzhan Shengmai capsule in people with Stroke, run by Guangzhou University of Traditional Chinese Medicine at 84 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 84 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

recurrence of stroke (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00548223.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2013.

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