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Study on the improvement of clinical phenotype of cerebral small-vessel disease by resolving phlegm and expelling blood stasis formula based on cerebral-like lymphatic-dependent cerebrospinal fluid-tissue interstitial fluid exchange disorder

Study on the improvement of clinical phenotype of cerebral small-vessel disease by resolving phlegm and expelling blood stasis formula based on cerebral-like lymphatic-dependent cerebrospinal fluid-tissue interstitial fluid exchange disorder

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083165
Enrollment
Unknown
Registered
2024-04-17
Start date
2024-04-20
Completion date
Unknown
Last updated
2024-04-22

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

Conditions

Cerebral small vessel disease

Interventions

Test group:Resolving Phlegm and Dispelling Blood Stasis formula (Semen xia 10g, Atractylodes macrocephala 10g, Tianma 10g, Poria)12g, Radix Codonopsis pilosulae 15g, Pericarpium Citri Reticulatae 12g,
Control group:Basic treatment (appropriate symptomatic treatment for blood pressure control, blood glucose, lipid lowering and anti-platelet aggregation)

Sponsors

Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Clinical manifestations related to CSVD, motor impairment, cognitive impairment, autonomic dysfunction symptoms, fulfillment of one of them is sufficient. (2) Cranial MRI examination with clear CSVD imaging manifestations, such as recent subcortical small infarcts, high signal in the white matter of the brain, cerebral microhemorrhage and so on. (3) Age =50 years, =80 years; (4) Voluntary participation in the trial and signing the informed consent form.

Exclusion criteria

Exclusion criteria: (1) The presence of tremor, claustrophobia, etc. leads to poor MRI image quality and affects the CSVD evaluation; (2) History of traumatic brain injury, serious psychiatric disorders, serious heart diseases, malignant tumors, etc. (3) History of multiple sclerosis, craniocerebral tumor, central nervous system demyelination, severe stenosis of intracranial and extracranial arteries, and so on. (4) Serious hearing, speaking, reading and writing disorders.

Design outcomes

Primary

MeasureTime frame
Tinetti Performance Oriented Mobility Assessment, POMA;

Secondary

MeasureTime frame
Montreal Cognitive Assessment, MoCA;Autonomic Symptom Profile, ASP;

Countries

China

Contacts

Public ContactZHANG HUI

Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine

13991057086@163.com+86 139 9105 7086

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026