ClinicalTrials.gg
Status unknownNCT03380481SECRETS-TCMUpdated Mar 8, 2018

SouthErn China REgisTry for Stroke on Traditional Chinese Medicine

An observational study in Stroke, Cerebral Infarction and Transient Ischemic Attack, sponsored by Yefeng Cai. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-08.

Primary conditionCerebral InfarctionRegistry: StrokeReclassifiedWhy we changed it
Registry
Stroke — the first condition term the registry derived for this study.
ClinicalTrials.gg
Cerebral Infarction
Why
  1. The study's listed conditions name Cerebral Infarction, a narrower term within Stroke.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Yefeng Cai · Observational

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10,000
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Stroke
  • Cerebral Infarction
  • Transient Ischemic Attack
  • Cerebral Hemorrhage
  • Subarachnoid Hemorrhage
03

In context

Cerebral Infarction Reclassified

219 studies on the registry are indexed under Cerebral Infarction; 46 are open to participants now.

This study's planned enrollment of 10,000 is above the median of 335 across 72 observational studies indexed under Cerebral Infarction.

Browse Cerebral Infarction studies →

Lead sponsor

This is the only study on the registry with Yefeng Cai as lead sponsor.

Compared within Cerebral Infarction, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Stroke. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population will be comprised of those who meet all inclusion criteria and no exclusion criteria. Study personnel will continuously screen eligible patients presenting to the hospitals until the sample size of 10000 is reached. This study will be conducted in more than 50 hopitals in southern China.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Patients with silent cerebrovascular disease.
  2. Patients with non-cerebrovascular disease events.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10,000 participants (estimated)
Target follow-up
24 Months
Patient registry
Yes

Groups and cohorts

  • SECRETS-TCM

    Stroke patients who treated by western medicine and/or traditional Chinese medicine in southern China

    Other: observational only-no intervention

Interventions

  • Otherobservational only-no intervention

    Observational only and no predesigned interventions in this study.

06

What researchers measure

Primary outcomes

  1. All-cause mortality

    Time frame: 12 months follow-up

  2. Composite cerebrovascular and cardiovascular events

    Including stroke recurrence events,acute myocardial infarction and cardiac death

    Time frame: 12 months follow-up

Secondary outcomes

  1. All-cause mortality

    Time frame: 24 months follow-up

  2. Composite cerebrovascular and cardiovascular events

    Including stroke recurrence events,acute myocardial infarction and cardiac death

    Time frame: 24 months follow-up

  3. Modified Rankin Scale(mRS)

    Range:Grade 0 to Grade 6, higher grade represent a worse outcome

    Time frame: 3 months follow-up

  4. Barthel Index(BI)

    Range:0 to 100 points, higher points represent a better outcome

    Time frame: 3 months follow-up

  5. Mini-Mental State Examination(MMSE)

    Range:0 to 30 points, higher points represent a better outcome

    Time frame: 3 months follow-up

  6. Modified Rankin Scale(mRS)

    Range:Grade 0 to Grade 6, higher grade represent a worse outcome

    Time frame: 12 months follow-up

  7. Barthel Index(BI)

    Range:0 to 100 points, higher points represent a better outcome

    Time frame: 12 months follow-up

  8. Mini-Mental State Examination(MMSE)

    Range:0 to 30 points, higher points represent a better outcome

    Time frame: 12 months follow-up

  9. Modified Rankin Scale(mRS)

    Range:Grade 0 to Grade 6, higher grade represent a worse outcome

    Time frame: 24 months follow-up

  10. Barthel Index(BI)

    Range:0 to 100 points, higher points represent a better outcome

    Time frame: 24 months follow-up

  11. Mini-Mental State Examination(MMSE)

    Range:0 to 30 points, higher points represent a better outcome

    Time frame: 24 months follow-up

07

Study locations

1 of 1 sites recruiting
  • Wuyi Traditional Chinese Medicine Hospital of Jiangmen
    Jiangmen, Guangdong 529000, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03380481
Lead sponsor
Yefeng Cai
Responsible party
Yefeng Cai (Director of Encephalopathy Center of Guangdong Provincial Hospital of Chinese Medcicine, Guangzhou University of Traditional Chinese Medicine) — Sponsor-investigator
First posted
Dec 21, 2017
Start date
Jan 15, 2018
Primary completion
Dec 31, 2020 (estimated)
Completion
Dec 31, 2020 (estimated)
Last update
Mar 8, 2018

Study contacts

Yefeng Cai, M.D.,PhD
Contact
caiyefeng@126.com
+86-13631333842
Xinfeng Guo, PhD
Contact
guoxinfeng@gzucm.edu.cn
+86-13678906862
Yefeng Cai, M.D.,Ph D
principal investigator · Guangdong Provincial Hospital of Traditional Chinese Medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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