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Randomized double-blind controlled prospective study on the efficacy of Yizhi Decoction in the treatment of Alzheimer's disease

Not Applicable
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
Inclusion Criteria

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.

Exclusion Criteria

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
NameTimeMethod
Biochemical detection index;Psychoaffective assessment;General cognitive tests;Proteomic detection;Cognitive domain test;Imaging Characteristics;Genetic detection;
Secondary Outcome Measures
NameTimeMethod
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;
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