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

Phase 1

Recruiting

• Conditions: Vascular Dementia

• Registration Number: ITMCTR2100004261
• Lead Sponsor: Hubei University of Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Observational study
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Blood lipids;Oxidative stress;Inflammatory factors;transcranial Doppler, TCD;