The effects and safety of Shen zhi ling oral liquid for the treatment of amnestic mild cognitive impairment (aMCI) and mild Alzheimer's disease (AD) (heart qi deficiency syndrome),: randomized, double-blind, placebo-controlled, multi-center clinical trial study

The effects and safety of Shen zhi ling oral liquid for the treatment of amnestic mild cognitive impairment (aMCI) and mild Alzheimer's disease (AD) (heart qi deficiency syndrome): randomized, double-blind, placebo-controlled, multi-center clinical trial study

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IPR-15007499

Enrollment

Unknown

Registered

2015-11-13

Start date

2015-11-01

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

Amnestic mild cognitive impairment (aMCI) and mild Alzheimer's disease (AD) (heart qi deficiency syndrome)

Interventions

aMCI treatment group:Shen zhi ling oral liquid

aMCI control group:Shen zhi ling oral liquid Mimetics

AD treatment group:Donepezil hydrochloride+Shen zhi ling oral liquid

AD control group:Donepezil hydrochloride+Shen zhi ling oral liquid Mimetics

Eligibility

Sex/Gender

All

Age

50 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Aged 50 to 85; 2. Memory loss >=6 months duration, confirmed by others; 3. MMSE score 22-26; 4. Meet the amnestic mild cognitive impairment (MCI) or Alzheimer's disease (AD) diagnostic criteria; 5. TCM syndrome differentiation is qi deficiency Syndrome 6. MRI findings in line with the requirements of the subject; 7. sufficient visual and auditory resolution acceptable neuropsychological tests; 8. There is a certain level of education, read simple texts and write simple sentences; 9. A stable caregiver; 10. Signed the inform consent.

Exclusion criteria

Exclusion criteria: 1. suffering from vascular dementia or other causes of dementia, including VaD, Parkinson's disease, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, epilepsy, chronic subdural hematoma and multiple sclerosis, severe head trauma with persistent neurological deficits or abnormal brain structure known; 2. cerebrovascular disease, thyroid disease, vitamin B12 or folate deficiency, anemia or severe malnutrition, severe heart, liver, lung, kidney and other organ disease affecting the central nervous system dysfunction; cerebral vascular disease where the evidence in single or multiple vascular territories, and cognitive decline associated with brain infarction important parts, including the angular gyrus, thalamus, basal forebrain, the anterior cerebral artery territory back to the brain, multiple basal ganglia infarcts, white matter ischemic changes involving extensive white matter region least a full 25% or more; 3. allergies ,Aricept or hydrochloric acid piperidine derivatives allergy; 4. taking cholinergic or anticholinergic drugs and drugs that affect cognitive function at the same period; 5. depression, schizophrenia and other mental illness; 6. alcohol, long-term use of antipsychotics; 7. can not coordinate with cognitive function tests.

Design outcomes

Primary

Measure	Time frame
MMSE;ADAS-Cog;	—

Secondary

Measure	Time frame
Alzheimer's disease (AD) conversions;CIBIC-Plus;TCM symptom score;MRI;	—

Countries

China

Contacts

Public ContactYingzi Zeng

zengyingziwh@126.com+86 13505360589

Outcome results

None listed

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