Alzheimer's disease
Conditions
Interventions
Test group:Shenxiong Huanglian detoxification granules (1 sachet in the morning and evening, orally) + Donepezil tablets (5mg/ tablet, oral, 1 tablet a time, before going to bed at night, the dose mai
Control group:Donepezil tablets (5mg/ tablet, oral, 1 tablet a time, before going to bed at night, the dose maintained for 4 weeks and increased to 2 tablets before going to bed at night), the course
Sponsors
The Third Affiliated Hospital of Guangzhou University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
55 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Compliant with the 2011 diagnostic criteria of the National Institute of Aging and Alzheimer's Association (NIA-AA) for dementia likely caused by Alzheimer's disease in the United States; 2. Traditional Chinese medicine diagnosis encompasses deficiency, damage, stasis, and toxin syndrome; 3. Mild to moderate AD patients: Total MMSE scores range from 10-26 points; Clinical Dementia Rating Scale (CDR) scores range between 1-2 points; 4. Age ranges from 55 to 85 years old; 5. The minimum course of the disease is >= 6 months; 6. Subjects are capable of completing neuropsychological tests; And able to cooperate with cranial MRI examination (resting for more than 20 minutes), if unable to cooperate with cranial MRI examination, at least complete cranial CT examination; 7. The subjects have reliable caregivers; 8. Both the participant and their legal guardian or authorized principal agree to voluntary participation in the experiment and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Dementia caused by other factors such as vascular dementia, Lewy body dementia, frontotemporal dementia, brain tumors, hydrocephalus, or alcoholism; 2. Individuals with severe circulatory, respiratory, digestive, and other diseases; 3. Severe liver or kidney dysfunction; 4. Those who have taken medication that affects cognitive function, other than the study medication, within one month; 5. Individuals with known allergies to the ingredients of the drug used in this study or with an allergic constitution.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alzheimer's Disease Rating Scale-Cognition (ADAS-cog); | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Dementia Rating Scale (CDR);mini-mental state examination (MMSE);Tradition Chinese Medicine syndrome differentiation and score system;activities of daily living (ADL); | — |
Countries
China
Contacts
Public ContactLin Xingdong
The Third Affiliated Hospital of Guangzhou University of Chinese Medicine
Outcome results
None listed