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Study on the clinical efficacy of "Xingnao Kaiqiao Formula" in patients with post-stroke cognitive impairment (wind phlegm blood stasis type) based on EEG micro state exploration

Study on the clinical efficacy of "Xingnao Kaiqiao Formula" in patients with post-stroke cognitive impairment (wind phlegm blood stasis type) based on EEG micro state exploration

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000277
Enrollment
Unknown
Registered
2026-02-03
Start date
2025-10-20
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

stroke

Interventions

experimental group:Xingnaolaiqiao Fang

Sponsors

The First Affiliated Hospital of Henan University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Meets the diagnostic criteria for stroke; (2) After evaluation with MMSE and/or MoCA scales, it was determined that there was cognitive impairment; (3) Complies with the wind phlegm blood stasis syndrome type; (4) Cognitive impairment occurs after stroke and other causes are ruled out; (5) The course of the disease ranges from 2 weeks to 6 months, with clear consciousness and stable condition; (6) Age range: 18 to 75 years old; (7) With the consent of the patient or their legal guardian and the signing of an informed consent form.

Exclusion criteria

Exclusion criteria: (1) During the treatment period, if a stroke occurs again, or if the condition develops and vital signs are unstable; (2) Acute phase of cerebrovascular disease, such as acute phase of subarachnoid hemorrhage or brain edema not yet absorbed after cerebral hemorrhage; (3) Individuals with severe aphasia, severe hearing comprehension or expression disorders that affect cognitive function tests; (4) Patients who are currently taking or have used drugs that affect the central nervous system (such as sedatives, hypnotics, epilepsy, antipsychotics) within 7 days prior to EEG monitoring; (5) Those who are unable to cooperate in completing information collection or have data quality issues due to electrode detachment or other reasons; (6) Patients with severe digestive disorders, active ulcers, or other gastrointestinal diseases that affect drug absorption; (7) Do not use for individuals allergic to the "Awakening Brain and Opening up the Mind Formula"; (8) Patients who are currently participating in other studies.

Design outcomes

Primary

MeasureTime frame
Montreal Cognitive Assessment Scale;Mini-Mental State Examination;

Secondary

MeasureTime frame
Modified Barthel Index;Traditional Chinese Medicine Syndrome Scale for Stroke;

Countries

China

Contacts

Public Contactzhangming

Department of Rehabilitation Center, the First Affiliated Hospital of Henan University of Traditional Chinese Medicine

fengyachen2024@163.com15937160996

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Mar 14, 2026