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The effect of modified Liuwei Dihuang Decoction combined with donepezil hydrochloride on cognitive ability and oxidative stress response in AD patients

The effect of modified Liuwei Dihuang Decoction combined with donepezil hydrochloride on cognitive ability and oxidative stress response in AD patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001146
Enrollment
Unknown
Registered
2026-05-07
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Alzheimers disease

Interventions

Control Group:Donepezil hydrochloride treatment
Observation group:Modified Liuwei Dihuang Decoction combined with donepezil hydrochloride treatment

Sponsors

First Affiliated Hospital of Nanyang Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1) Diagnosed with Alzheimer's Disease (AD) according to the "2018 Chinese Guidelines for the Diagnosis and Treatment of Dementia and Cognitive Disorders (II): Guidelines for the Diagnosis and Treatment of Alzheimer's Disease", and exhibiting mild to moderate dementia; 2) Aged between 50 and 80 years old; 3) Diagnosed as kidney yin deficiency type according to the "Consensus on the Diagnosis and Treatment of Alzheimer's Disease with Traditional Chinese Medicine": primary symptoms include decreased intelligence, soreness and weakness in the waist and knees, fatigue and a desire to sleep; secondary symptoms include dull expression, fearfulness and proneness to panic, brain whirring and tinnitus, heavy gait, urinary incontinence, and spontaneous fecal incontinence; tongue thin and pale with little coating, and pulse deep and weak; 4) Educational level of =5 years; 5) Patient's guardian has signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Secondary dementia caused by clear reversible factors such as hypothyroidism, vitamin B12 deficiency, and neurosyphilis; 2) Presence of severe hepatic and renal insufficiency, cerebrovascular disease, cardiac insufficiency, or uncontrolled severe hypertension and diabetes; 3) Long-term history of alcohol abuse or drug abuse; 4) Allergic constitution; 5) Severe communication barriers determined by the researcher, making it impossible to cooperate with cognitive assessment; 6) Presence of significant neuropsychiatric disorders affecting cognitive testing.

Design outcomes

Primary

MeasureTime frame
Overall efficacy rate;

Secondary

MeasureTime frame
TCM Syndrome Score;The average blood flow velocity of cerebral vessels;Breath-Holding Index;Glutathione peroxidase;superoxide dismutase;Alzheimer's Disease Assessment Scale;auditory verbal learning test;Activities of Daily Living Scale;

Countries

China

Contacts

Public ContactChen Min

The First Affiliated Hospital of Nanyang Medical College

1129431646@qq.com13781779178

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 11, 2026