Alzheimers disease
Conditions
Interventions
Group of the PingXinYiZhi Formula:Standard treatment + the PingXinYiZhi Formula
placebo group:Standard treatment + placebo
Sponsors
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
50 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1) Meets the diagnostic criteria for AD and BPSD; (2) Aged 50–85 years, regardless of gender; (3) Clinical stage 3–4 (MCI, mild dementia), with a CDR score of 0.5 = CDR = 1; (4) NPI score = 4; (5) Sufficient visual and hearing acuity to undergo neuropsychological assessment; (6) No impairment of consciousness or delirium; (7) The patient and their family consent to participate in this trial and have signed an informed consent form
Exclusion criteria
Exclusion criteria: (1) Mental disorders or mental retardation, or other types of dementia; (2) Diseases causing cognitive impairment and neuropsychiatric symptoms due to other causes; (3) Severe internal medical conditions affecting the heart, liver, lungs, kidneys, etc., or malignant tumours; (4) Traumatic brain injury; (5) A history of specific medication use that may affect cognitive function; (6) Individuals with a history of allergy, contraindications, or intolerance to the main ingredients of Pingxin Yizhi Formula (Coptis, Huaimai, Bupleurum, Paeonia alba, Platycodon, Curcuma, Polygala, Achyranthes, Astragalus, Rehmannia glutinosa, Cistanche, and raw Glycyrrhiza).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neuropsychiatric Inventory, NPI; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mini-Mental State Examination, MMSE;Montreal Cognitive Assessment, MoCA;Auditory Verbal Learning Test, AVLT;Clock Drawing Test, CDT;Digit Span Test, DST;Boston Naming Test, BNT;Hamilton Anxiety Scale, HAMA;Hamilton Depression Scale, HAMD;Pattern Element Scale for Dementia, PES-D;Pittsburgh sleep quality index, PSQI;Fatigue Severity Scale, FSS;Activity of Daily Living Scale, ADL;Red Cell Distribution Width to Platelet Ratio, RPR; Monocyte-to-Lymphocyte Ratio, MLR; Neutrophil-to-Lymphocyte Ratio, NLR; Platelet-to-Lymphocyte Ratio, PLR; Systemic Immune-Inflammation Index, SII; Systemic Inflammation Response Index, SIRI;Aggregate Index of Systemic Inflammation, AISI; | — |
Countries
China
Contacts
Public ContactZhang Yunyun
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Outcome results
None listed