Register Now
Log In
中文/English
About ITMCTR|Search Trials|About Us|News
Follow up registration study on prevention and treatment of cerebrovascular diseases with traditional Chinese medicine in Beijing

Registration number：

ITMCTR2200006820

Date of Last Refreshed on：

2022-11-24

Date of Registration：

2022-11-24

Registration Status：

Prospective registration

Public title：

Follow up registration study on prevention and treatment of cerebrovascular diseases with traditional Chinese medicine in Beijing

English Acronym：

Scientific title：

Follow up registration study on prevention and treatment of cerebrovascular diseases with traditional Chinese medicine in Beijing

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

ChiCTR2200066107 ; ChiMCTR2200006820

Applicant：

Dong Xinglu

Study leader：

Gao ying

Applicant telephone：

13426215689

Study leader's telephone：

13366275793

Applicant Fax：

Study leader's fax：

Applicant E-mail：

arthasdxl@163.com

Study leader's E-mail：

gaoying973@126.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

5 Haiyangcang, Dongcheng District, Beijing

Study leader's address：

5 Haiyangcang, Dongcheng District, Beijing

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

2022DZMEC-275-02

Approved file of Ethical Committee：

View

Name of the ethic committee：

Medical Ethics Committee of Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine

Date of approved by ethic committee：

2022/10/10 0:00:00

Contact Name of the ethic committee：

Contact Address of the ethic committee：

Contact phone of the ethic committee：

Contact email of the ethic committee：

Primary sponsor：

Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine

Primary sponsor's address：

5 Haiyangcang, Dongcheng District, Beijing

Secondary sponsor：

Country：

China

Province：

Bei jing

City：

Institution
hospital：

Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine

Address：

5 Haiyangcang, Dongcheng District, Beijing

Source(s) of funding：

Gao Ying - Brain Disease Prevention Office Funding 4

Target disease：

Cerebrovascular disease

Target disease code：

Study type：

Observational study

Study design：

Cohort study

Study phase：

Others

Objectives of Study：

To study the impact of Chinese medicine intervention in cerebrovascular disease treatment in Beijing on the clinical outcome and health economics of stroke patients, in order to further optimize the academic model, service model and management model of Chinese medicine for cerebrovascular disease in Beijing, reform the medical service of Chinese medicine, and improve the level of prevention and treatment of cerebrovascular disease in Beijing.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

(1) Conform to the diagnostic criteria of western medicine for cerebrovascular disease (acute ischemic stroke or hemorrhagic stroke confirmed by imaging after admission within 14 days of onset); (2) This study is a follow-up registration study, with no special requirements on age and gender; (3) Obtain the consent of patients and their families, and sign the informed consent form;

Exclusion criteria：

Patients who cannot complete the follow-up work on time due to personal reasons of the subjects or have difficulties in telephone and outpatient follow-up due to conditional factors;

Study execute time：

From 2022-12-01

To      2025-12-01

Recruiting time：

From 2022-12-01

To      2023-12-01

Interventions：

600

Group：

NO

Sample size：

Intervention：

NO

Intervention code：

Total sample size ： 600

Countries of recruitment
and research settings：

Country：

China

Province：

beijing

City：

Institution/hospital：

Beijing Daxing District Integrated Traditional Chinese and Western Medicine Hospital

Level of the institution：

Tertiary A

Country：

China

Province：

beijing

City：

Institution/hospital：

Beijing Hepingli Hospital

Level of the institution：

Tertiary A

Country：

China

Province：

beijing

City：

Institution/hospital：

Beijing Longfu Hospital

Level of the institution：

Tertiary A

Country：

China

Province：

beijing

City：

Institution/hospital：

Beijing Xuanwu Hospital of Traditional Chinese Medicine

Level of the institution：

Grade III hospital

Country：

China

Province：

beijing

City：

Institution/hospital：

Changping District Integrated Traditional Chinese and Western Medicine Hospital

Level of the institution：

Tertiary A

Country：

China

Province：

beijing

City：

Institution/hospital：

Beijing First Integrated Hospital of Traditional Chinese and Western Medicine

Level of the institution：

Tertiary A

Country：

China

Province：

beijing

City：

Institution/hospital：

Huguosi Hospital of Traditional Chinese Medicine affiliated to Beijing University of Traditional Chinese Medicine

Level of the institution：

Tertiary A

Country：

China

Province：

beijing

City：

Institution/hospital：

Beijing Traditional Chinese Medicine Hospital Affiliated to Capital Medical University

Level of the institution：

Tertiary A

Country：

China

Province：

beijing

City：

Institution/hospital：

Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine

Level of the institution：

Tertiary A

Country：

China

Province：

beijing

City：

Institution/hospital：

Beijing Chaoyang Integrated Traditional and Western Medicine Rescue Center

Level of the institution：

Grade III hospital

Country：

China

Province：

beijing

City：

Institution/hospital：

Fangshan Hospital of Beijing University of Traditional Chinese Medicine

Level of the institution：

Tertiary A

Country：

China

Province：

beijing

City：

Institution/hospital：

Guang'anmen Hospital, Chinese Academy of Traditional Chinese Medicine

Level of the institution：

Tertiary A

Country：

China

Province：

beijing

City：

Institution/hospital：

Oriental Hospital of Beijing University of Traditional Chinese Medicine

Level of the institution：

Tertiary A

Country：

China

Province：

beijing

City：

Institution/hospital：

Beijing Huairou District Hospital of Traditional Chinese Medicine

Level of the institution：

Tertiary A

Country：

China

Province：

beijing

City：

Institution/hospital：

Beijing Pinggu Hospital of Traditional Chinese Medicine

Level of the institution：

Tertiary A

Outcomes：

Outcome：

Whether to add cardiovascular events

Type：

Secondary indicator

Measure time point of outcome：

Baseline (at discharge), 3, 6, 12 months after onset, followed up once every six months until the end point event such as patient death or failure to cooperate

Measure method：

follow-up

Outcome：

Stroke-PRO

Type：

Primary indicator

Measure time point of outcome：

Baseline (at discharge), 3, 6, 12 months after onset, followed up once every six months until the end point event such as patient death or failure to cooperate

Measure method：

follow-up

Outcome：

Whether to return on time

Type：

Secondary indicator

Measure time point of outcome：

Baseline (at discharge), 3, 6, 12 months after onset, followed up once every six months until the end point event such as patient death or failure to cooperate

Measure method：

follow-up

Outcome：

Whether death occurs

Type：

Secondary indicator

Measure time point of outcome：

Baseline (at discharge), 3, 6, 12 months after onset, followed up once every six months until the end point event such as patient death or failure to cooperate

Measure method：

follow-up

Outcome：

Whether there is recurrence of cerebrovascular disease after discharge

Type：

Secondary indicator

Measure time point of outcome：

Baseline (at discharge), 3, 6, 12 months after onset, followed up once every six months until the end point event such as patient death or failure to cooperate

Measure method：

follow-up

Outcome：

Current medication

Type：

Secondary indicator

Measure time point of outcome：

Baseline (at discharge), 3, 6, 12 months after onset, followed up once every six months until the end point event such as patient death or failure to cooperate

Measure method：

follow-up

Outcome：

Modified Rankin Scale

Type：

Primary indicator

Measure time point of outcome：

Baseline (at discharge), 3, 6, 12 months after onset, followed up once every six months until the end point event such as patient death or failure to cooperate

Measure method：

follow-up

Outcome：

Barthel Index

Type：

Primary indicator

Measure time point of outcome：

Baseline (at discharge), 3, 6, 12 months after onset, followed up once every six months until the end point event such as patient death or failure to cooperate

Measure method：

follow-up

Outcome：

Whether to be hospitalized again

Type：

Secondary indicator

Measure time point of outcome：

Baseline (at discharge), 3, 6, 12 months after onset, followed up once every six months until the end point event such as patient death or failure to cooperate

Measure method：

follow-up

Collecting sample(s)
from participants：

Sample Name：

NO

Tissue：

Fate of sample 

Destruction after use

Note：

Not yet recruiting

Min age years
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

This study does not involve randomization. Information collection and follow-up work will be carried out according to the actual treatment and medication of patients, and the collected information will be further studied and analyzed.

Blinding：

IPD sharing：

Yes

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Upload the data to the Chinese clinical trial database within one year after the completion of this study

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

The data acquisition involved in this study adopts a follow-up platform composed of an electronic data acquisition system. The data management center is responsible for the summary, logical verification and analysis of the follow-up platform data

Data Managemen Committee：

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

back
Platform information
About ITMCTR
About Us
Register Trials
Frequently Asked Questions
Ethical Review
The public service
Search Trials
Join Us
ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above