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Efficacy and safety of Yizhiqingxin decoction for the treatment of mild to moderate Alzheimer's disease(deficiency, blood-stasis and toxic syndrome): A Randomized Controlled Trial

Efficacy and safety of Yizhiqingxin decoction for the treatment of mild to moderate Alzheimer's disease(deficiency, blood-stasis and toxic syndrome): A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072250
Enrollment
Unknown
Registered
2023-06-07
Start date
2023-07-01
Completion date
Unknown
Last updated
2023-06-18

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

Conditions

Alzheimer's disease

Interventions

The YZQXD group:Yizhiqingxin decoction(YZQXD) granules (1 bag, twice daily),take 3 months continuously.
The control group:donepezil hydrochloride tablets(5mg/tablet),1 tablet orally at bedtime daily,increasing to 2 tablets at bedtime after 4 weeks of dose maintenance for 3 months.

Sponsors

Xiyuan Hospital of China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 85 Years

Inclusion criteria

Inclusion criteria: (1) Age = 50 years, = 85 years, male or female. (2) Meet the diagnostic criteria of the National Institute of Neurological Disorders, Speech Disorders, and Stroke Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA). (3) Meet the diagnostic criteria for dementia with evidence of deficiency, blood-stasis and toxic. (4) Patients with mild to moderate disease: total score of 10-26 on the Simple Mental State Examination; score of 1-2 on the Clinical Dementia Rating Scale; total score of =4 on the Harkinski Ischemia Index. (5) Patients for whom there had been head scans (CT or MRI) imaging evidence supporting the diagnosis of AD, and these head scans were performed in the past one year or before enrollment. (6) Sufficient visual and auditory discrimination to undergo neuropsychological testing. (7) A certain level of literacy, with the ability to read simple texts and write simple sentences in the past. (8) have a stable caregiver; voluntary and legal guardian consent to participate, and jointly sign an informed.

Exclusion criteria

Exclusion criteria: (1) Other causes of dementia such as vascular dementia, Lewy body dementia or frontotemporal dementia, etc. Dementia symptoms caused by other diseases such as vitamin B12 or folate deficiency, hypothyroidism, etc. (2) Other neurological or psychiatric diseases that cause dementia such as Parkinson's disease, Huntington's disease, hydrocephalus, severe traumatic brain injury, alcoholic encephalopathy, depression, schizophrenia, or epilepsy, etc. (3) Patients with liver or kidney abnormalities. (4) Those who have taken other Chinese medicines containing the herbal ingredients of this test within 1 month. (5) Those who have taken cholinergic drugs, anticholinergic drugs or drugs that affect cognitive function during the same period. (6) Allergic persons or those who are allergic to the ingredients of the study drugs.

Design outcomes

Primary

MeasureTime frame
score of the Alzheimer’s Disease Assessment Scale–Cognitive Subscale (ADAS-Cog);

Secondary

MeasureTime frame
score of the Mini-mental State Examination(MMSE);score of the Activity of Daily Living Scale(ADL);score of the Chinese Medicine syndrome Score Scale(deficiency,blood-stasis and toxic syndrome);

Countries

China

Contacts

Public ContactPei Hui

Xiyuan Hospital of China Academy of Chinese Medical Sciences

phxydoctor@126.com+86 10 6283 5631

Outcome results

None listed

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