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

Study on syndrome differentiation standard of yin deficiency syndrome in Alzheimer's disease

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2100004335

Enrollment

Unknown

Registered

2021-01-28

Start date

2021-02-01

Completion date

Unknown

Last updated

2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer disease

Interventions

Experimental group:Donepezil Hydrochloride

control group:Donepezil Hydrochloride

Experimental group:Liuwei Dihuang pill

control group:placebo

Eligibility

Sex/Gender

All

Age

50 Years to 85 Years

Inclusion criteria

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 = 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

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.

Design outcomes

Primary

Measure	Time frame
Clinical dementia rating scale;Alzheimer disease assessment scale-Cognitive portion ;	—

Secondary

Measure	Time frame
MRI;TCM Syndrome Scale;activity of daily living (ADL);Mini-Mental State Examinati;	—

Countries

China

Contacts

Public ContactCheng Weidong

Traditional Chinese Pharmacological Laboratory, School of Traditional Chinese Medicine, Southern Medical University

chengweidong888@sina.com+86 18665000116

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026