Bushen Kaiqiao recipe in the treatment of Alzheimer's disease (medullary sea deficiency): a real-world study

Phase 1

Recruiting

Conditions: Alzheimer's disease

Registration Number: ITMCTR2100004415

Lead Sponsor: Shanghai Municipal Hospital of Traditional Chinese Medicine

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. They signed informed consent (subjects and caregivers) and were willing to carry out various examinations and assessments according to the visiting time specified in the trial;
2. Aged >= 50 and <= 80, regardless of gender;
3. According to the diagnostic criteria of Alzheimer's disease association (nia-aa) proposed by the National Institute on aging in 2011 (see Appendix 1), the patients with probable AD and probable AD were diagnosed;
4. According to the oral statement of the subjects or caregivers, the memory loss of the subjects was at least 6 months, and it was gradually aggravated;
5. For patients with mild or moderate illness, the diagnostic cut-off value was adjusted according to the education level. For subjects with university education level, 11 points <= MMSE total score <= 26 points, middle school education level subjects, 11 points <= MMSE total score <= 24 points, and primary school education level subjects, 11 points <= MMSE total score <= 23 points.
6. The syndrome differentiation of ad is marrow sea deficiency;
1) The expression is dull, the language does not express the meaning,
2) Dizziness, tinnitus, withered teeth and scorched hair
3) The tongue is thin and light, and the pulse is deep and weak
One of the above three symptoms can be diagnosed as medullary sea deficiency,
7. The subjects had primary school education and were able to complete the cognitive ability test and other tests specified in the program
8. Subjects should have stable caregivers or at least be able to contact caregivers frequently (at least 4 days a week, at least 2 hours a day). Caregivers will help patients to participate in the whole process of the study. They must accompany the subjects to participate in the study visit, and have sufficient interaction and communication with the subjects, so that the scale scores can provide valuable information.

Exclusion Criteria

1. Non ad induced memory and cognitive impairment, such as the diagnosis of other types of dementia, including mixed dementia (ad-vad), vascular dementia (VD), Parkinson's disease dementia (PDD), Lewy body dementia (PLB), Huntington's disease-related dementia, frontotemporal lobe dementia (FTD), and the presence of disturbance of consciousness, delirium, etc.;
2. Patients with severe neurological impairment who cannot complete the examination;
3. There are uncorrectable audiovisual impairment, unable to complete the cognitive ability test and other tests specified in the program;
4. At least 4 weeks before taking antidepressant drugs, the central nervous system function was not affected by anti hypnotic drugs;
5. Patients with impaired liver and kidney function and coagulation disorders;
6. There are other clinical diseases that are difficult to control (such as tumor, HIV infection, hepatitis C virus infection, active hepatitis B or other serious chronic infection, serious mental, nervous, cardiovascular, respiratory and other system diseases, etc.);
7. Allergic to the experimental drug;
8. Those who are participating in clinical trials of other drugs or have participated in clinical trials of any drug (excluding vitamins and minerals) one month before screening;
9. Pregnant and lactating women;
10. The researchers believe that they need to be excluded.