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SouthErn China REgisTry for Stroke on Traditional Chinese Medicine

SouthErn China REgisTry for Stroke on Traditional Chinese Medicine

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03380481
Acronym
SECRETS-TCM
Enrollment
10000
Registered
2017-12-21
Start date
2018-01-15
Completion date
2020-12-31
Last updated
2018-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Hemorrhage, Cerebral Infarction, Stroke, Subarachnoid Hemorrhage, Transient Ischemic Attack

Brief summary

Stroke is the first most common cause of death in China and one of the major causes of functional disability in the adult population.The burden of stoke is significantly increased in China in recent years. In order to investigate the prognosis of stroke, with diagnostic and treatment information of traditional Chinese medicine (TCM), and assess the effectiveness and safety of TCM for stroke in southern China, the investigators will conduct this multicenter prospective registry study in southern China. This study will recruit 10,000 consecutive eligible patients with acute stroke from more than 50 hospitals. 24 months follow-up will be carried out on-site in hospitals and by telephone to track endpoint (including all-cause mortality, composite cerebrovascular and cardiovascular events at one and two year follow up, and neurological and functional assessments).

Interventions

OTHERobservational only-no intervention

Observational only and no predesigned interventions in this study.

Sponsors

Yefeng Cai
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. ≥18 years. 2. Patients within 14 days of onset of acute stroke (including acute cerebral infarction, transient ischemic attack, acute cerebral hemorrhage, acute subarachnoid hemorrhage). 3. The patient and/or guardian agree to participate in this study.

Exclusion criteria

1. Patients with silent cerebrovascular disease. 2. Patients with non-cerebrovascular disease events.

Design outcomes

Primary

MeasureTime frameDescription
All-cause mortality12 months follow-up
Composite cerebrovascular and cardiovascular events12 months follow-upIncluding stroke recurrence events,acute myocardial infarction and cardiac death

Secondary

MeasureTime frameDescription
Modified Rankin Scale(mRS)3 months follow-upRange:Grade 0 to Grade 6, higher grade represent a worse outcome
All-cause mortality24 months follow-up
Mini-Mental State Examination(MMSE)3 months follow-upRange:0 to 30 points, higher points represent a better outcome
Barthel Index(BI)3 months follow-upRange:0 to 100 points, higher points represent a better outcome
Composite cerebrovascular and cardiovascular events24 months follow-upIncluding stroke recurrence events,acute myocardial infarction and cardiac death

Countries

China

Contacts

Primary ContactYefeng Cai, M.D.,PhD
caiyefeng@126.com+86-13631333842
Backup ContactXinfeng Guo, PhD
guoxinfeng@gzucm.edu.cn+86-13678906862

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026