Clinical Study on the Treatment of mild - moderate Vascular Dementia of Phlegm Heat Stasis syndrome with Qinzhi zhudan decoction

Study on the new drug development of Shuangdanqinzhi tablet in the treatment of Vascular Dementia

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100043806

Enrollment

Unknown

Registered

2021-03-03

Start date

2021-03-01

Completion date

Unknown

Last updated

2021-06-28

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

Conditions

Mild - moderate Vascular Dementia

Interventions

1:Take Chinese medicine Qinzhi zhudan decoction

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Subjects who met the diagnostic criteria of vascular dementia, the course of disease lasted more than 3 months; TCM syndrome differentiation belongs to phlegm heat stasis syndrome; 2. According to mini mental state examination (MMSE), the subjects met the criteria of mild and moderate dementia (MMSE >= 10 points); 3. Subjects with his score >= 7 (Appendix 3); 4. Male subjects weighing 50-90kg and female subjects weighing 40-80kg; 5. The subjects aged between 45-80 years old should be infertile postmenopausal women (menopause for at least one year); 6. The subjects with a certain level of education can read simple newspapers and write simple sentences; 7. Patients or guardians voluntarily participate in the clinical trial and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. For patients with Alzheimer's disease or dementia of other reasons, his score was less than 7; 2. Patients with cognitive impairment caused by head injury; 3. Patients with certain diseases that can interfere with the evaluation of cognitive function, such as severe hand hemiplegia, aphasia, visual and auditory impairment, including alcoholics, drug abusers or other psychotropic drug abusers; 4. Patients with transient organic psychosis (such as exogenous depression, schizophrenia), depression or other mental disorders meeting DSM - ? criteria; 5. Patients with epilepsy, encephalitis, Parkinson's disease or other dementia causing dementia; 6. Patients with liver, kidney or heart failure, such as those whose ALT or ast are more than 3 times the normal value, or whose serum creatinine is more than 177umol / L, or whose heart function is 2-4 grade; 7. Patients with other diseases that can cause cognitive impairment, such as malignant tumor, thyroid dysfunction, syphilis, and severe anemia; 8. Subjects allergic to the product.

Design outcomes

Primary

Measure	Time frame
Clinical Dementia Rating,CDR-SD;Alzheimer’s Disease Assessment Scale-Cognitive section,ADAS-cog;	—

Secondary

Measure	Time frame
activity of daily living;TCM syndrome scores;	—

Countries

China

Contacts

Public ContactFafeng Cheng

Beijing University of Traditional Chinese Medicine

ch5328373@sohu.com+86 13810419194

Outcome results

None listed

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