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Multicenter, Randomized, Controlled Evidence-Based Clinical Study on the Efficacy and Safety of Yinao Huichun Formula in Treating Mild to Moderate Alzheimer's Disease

Multicenter, Randomized, Controlled Evidence-Based Clinical Study on the Efficacy and Safety of Yinao Huichun Formula in Treating Mild to Moderate Alzheimer's Disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000296
Enrollment
Unknown
Registered
2026-02-09
Start date
2026-02-28
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Alzheimer's Disease

Interventions

Research Group:Donepezil + Yinao Huichun Formula

Sponsors

Tongde Hospital of Zhejiang Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age 60-75 years; 2. Education level above junior high school; 3. Right-handed; 4. Meet the Revised Diagnostic and Staging Criteria for Alzheimer's Disease (2024 edition) by NIA-AA; 5. Plasma p-tau217 positive; 6. MMSE =15; 7. CDR=1-2; 8. HIS (Hachinski Ischemic Score) =4; 9. TCM diagnosis conforms to 'Chinese Expert Consensus on Integrated TCM-WM Diagnosis and Treatment of Alzheimer's Disease (2024)' Suihai Buzu syndrome; 10. Alzheimer's Disease Syndrome Element Scale (A-PES-11) Marrow Deficiency =6; 11. Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Unstable diabetes, obstructive pulmonary disease or asthma; 2. History of coagulation disorders or malignancies in past 2 years; 3. Hypothyroidism; 4. Vitamin B or folate deficiency; 5. Clinically confirmed active gastrointestinal, renal, hepatic, endocrine or cardiovascular diseases; 6. Bradycardia or sick sinus syndrome; 7. Other neuro/psychiatric disorders: Parkinson's disease, stroke, epilepsy, bipolar/unipolar depression, schizophrenia; 8. History of loss of consciousness from head trauma or modified Hachinski score =4; 9. Known or suspected alcohol/drug abuse in past decade; 10. Impaired vision/hearing unrectifiable by aids

Design outcomes

Primary

MeasureTime frame
Overall Cognitive Function;

Secondary

MeasureTime frame
Neuroaxonal Function;

Countries

China

Contacts

Public ContactZhongwei Guo

Tongde Hospital of Zhejiang Province

guozw1977@aliyun.com13588448304

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Mar 14, 2026