Randomized double-blind controlled prospective study on the efficacy of Yizhi Decoction in the treatment of Alzheimer's disease
- Conditions
- Alzheimer's disease
- Registration Number
- ITMCTR2100005157
- Lead Sponsor
- Wuhan University of Science and Technology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1. Residents of the community, those who participate in the community elderly physical examination;
2. The age is 65-85 years old;
3. Expected survival period > 1 year;
4. No tumor, congenital or acquired immunodeficiency disease, congestive heart failure, angina pectoris, myocardial infarction, uncontrolled hypertension or arrhythmia and other serious heart diseases, active hepatitis, liver cirrhosis and other serious liver diseases , Any serious kidney disease such as glomerulonephritis, nephrotic syndrome, uremia, etc., without chronic diarrhea;
5. Blood routine and electrocardiogram were in the normal range when entering the group, the upper limit of liver and kidney function measurements was <=1.5 times the normal value, blood pressure systolic blood pressure <160mmHg, diastolic blood pressure <100mmHg;
6. Patients with mild to moderate AD, patients with mild cognitive impairment;
7. Elderly patients with depression;
8. Informed consent of patients or their guardians.
1. Patients with suicidal tendencies, that is, those with a score of >= 2 on the third item of the Hamilton Depression Scale;
2. Those with a history of drug allergy;
3. Alcoholism and/or psychoactive substances, drug abusers and dependents (including sleeping pills);
4. Those who do not use the prescribed medication, cannot judge the efficacy or incomplete data, etc., which affect the judgment of efficacy and safety;
5. Those who are unable to understand the contents of the scale due to insufficient awareness, language barriers, intelligence and education level (below primary school education);
6. Visual or hearing impairment prevents the test or assessor.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Biochemical detection index;Psychoaffective assessment;General cognitive tests;Proteomic detection;Cognitive domain test;Imaging Characteristics;Genetic detection;
- Secondary Outcome Measures
Name Time Method Anthropometric indexes;Family histories;Demographics and socioeconomic position;TCM Constitution Classification;Coating on the tongue;Behavior characteristics;Previous histories;Activities of daily living and basic activities of daily living;