Randomized controlled study of Liuwei Dihuang capsule in the treatment of yin deficiency syndrome of Alzheimer's disease

Phase 1

Recruiting

• Conditions: Alzheimer disease

• Registration Number: ITMCTR2100004335
• Lead Sponsor: Traditional Chinese Pharmacological Laboratory, School of Traditional Chinese Medicine, Southern Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(1) Aged 50-85 years;
(2) According to the core clinical diagnostic criteria of Alzheimer's disease dementia (2011) of National Institute on aging and Alzheimer's Association (nia-aa) or mild cognitive impairment caused by Alzheimer's disease (2011); according to the diagnostic scale of yin deficiency syndrome of Alzheimer's disease, it was judged as yin deficiency syndrome; the course of memory loss was more than 6 months and confirmed by others The possible manifestations of AD (asymmetric atrophy of medial temporal lobe or hippocampus, etc.) were found on MRI scan;
(3) Graduated from primary school or above, able to complete relevant tests and inspections;
(4) The patients with mild and moderate condition: the total score of mini mental state examination >= 11 and < 27; the total score of clinical dementia rating scale >= 0.5 and <= 2; the total score of haginsky ischemia scale <= 4;
(5) There are stable and reliable caregivers; voluntary and legal guardians agree to participate, and jointly sign the informed consent.

Exclusion Criteria

(1) Dementia caused by other reasons;
(2) severe cardiovascular system, respiratory system, digestive system, endocrine system, severe liver and kidney dysfunction;
(3) Those who are definitely diagnosed with depression, anxiety and other mental diseases or are taking anti anxiety and depression drugs; take other traditional Chinese medicine containing experimental traditional Chinese medicine ingredients within one month;
(4) Other situations that the researchers think are not suitable to participate in this study.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical dementia rating scale;Alzheimer disease assessment scale-Cognitive portion ;

Secondary Outcome Measures

Name	Time	Method
MRI;TCM Syndrome Scale;activity of daily living (ADL);Mini-Mental State Examinati;