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A Real World Study on Modified Danzhu Fuyuan Granule for Treatment of Vascular Dementia with Phlegm and Blood Stasis

Innovative research on the etiology, pathogenesis and diagnosis and treatment of vascular dementia

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100042122
Enrollment
Unknown
Registered
2021-01-14
Start date
2021-01-01
Completion date
Unknown
Last updated
2021-04-12

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

Conditions

Vascular Dementia

Interventions

Sponsors

Hubei University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. The age of the subjects was 35-85 years old; 2. It was in accordance with the diagnostic standard of Western medicine for vascular dementia; 3. It is in accordance with the diagnostic standard of TCM phlegm and blood stasis syndrome of vascular dementia; 4. They signed informed consent and volunteered to participate in the study; 5. The patients are expected to follow up within half a year.

Exclusion criteria

Exclusion criteria: 1. Early memory impairment with progressive deterioration, early prominent features of Parkinson's disease, and primary nervous system diseases (such as multiple sclerosis, encephalitis, etc.); 2. There was no vascular lesion in neuroimaging examination; 3. Other diseases that can explain cognitive impairment, such as brain tumor, multiple sclerosis,encephalitis, depression, poisoning, and systemic diseases and metabolic abnormalities that significantly affect cognitive function; 4. Severe heart, brain, liver and hematopoiesis diseases, or other serious diseases affecting their survival; 5. Drug or alcohol abuse / dependence within 3 months before participating in the trial; 6. Pregnant and lactating women; 7. Patients with severe mental disorders (perception disorders, thinking disorders); 8. For known renal insufficiency, serum creatinine (CR) was higher than 221 umol/L in male and 177 umol/L in female; 9. Patients with known liver dysfunction, alanine aminotransferase (ALT) > times of normal value or with cirrhosis; 10. The researchers believe that there are other situations that are not suitable for participating in this study.

Design outcomes

Primary

MeasureTime frame
The Mini Mental State Examination, MMSE;Activity of Daily Living, ADL;Integral Scale for Phlegm Turbidity and Blood Stasis Syndrome in Vascular Dementia;

Secondary

MeasureTime frame
transcranial Doppler, TCD;Blood lipids;Inflammatory factors;Oxidative stress;

Countries

China

Contacts

Public ContactHeyuan Shi

Hubei University of Chinese Medicine

shy79@hbtcm.edu.cn+86 13971278693

Outcome results

None listed

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