Cognitive impairment
Conditions
Interventions
Drug group:Jiannao Bushen Wan
Placebo group:Jiannao Bushen Wan placebo
Chinese medicine control group:Ginkgo tablet
Western medicine control group:Donepezil
Sponsors
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
50 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Age > 50 years, years of formal education >= 6, Normal vision and hearing; ability to complete neuropsychological assessments; 2. Cognitive impairment: includes patients or their informants reporting cognitive decline with objective evidence of cognitive impairment (including global cognition, memory, executive function, visuospatial ability, or language, as evidenced by scores on at least one cognitive domain test that is less than 1.5 standard deviations below the mean for the average elderly population); 3. TCM syndrome differentiation is kidney essence deficiency and (or) spleen and kidney deficiency.
Exclusion criteria
Exclusion criteria: 1.The patients were clinically diagnosed with moderate to severe dementia (by DSM-IV and NINCDS-ADRDA diagnostic criteria); 2.Confirmed diagnosis of a significant neuropsychiatric disorder with unstable or severe cardiac, pulmonary, hepatic, renal, or haematopoietic disorders; 3.Unable to complete neuropsychological tests and scale assessment due to other physical and mental diseases; 4.Have participated in or are participating in other drug trials within three months before enrollment; 5.Poor compliance, severe disease or life-threatening, and the expected survival time is less than one year, so the treatment cannot be completed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Auditory Verbal Learning Test;Mini-mental State Examination; | — |
Secondary
| Measure | Time frame |
|---|---|
| TCM syndrome score;Activity of Daily Living Scale;Rey-Osterrieth Complex Figure Test;Trail Making Test;Stroop Color Word Test;Clock Drawing Test;Symbol Digit Modalities Test;Verbal Fluency Test;Boston Naming Test;Self-Rating Anxiety Scale;Geriatric Depression Scale;Pittsburgh sleep quality index;Magnetic resonance imaging (Structural MRI and diffusion tensor imaging DTI); | — |
Countries
China
Contacts
Public ContactDao junxie
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Outcome results
None listed