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A randomized double-blind placebo-controlled trial of Shenghui decoction for the intervention of Alzheimer's disease-derived mild cognitive impairment

A randomized double-blind placebo-controlled trial of Shenghui decoction for the intervention of Alzheimer's disease-derived mild cognitive impairment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000043
Enrollment
Unknown
Registered
2025-01-07
Start date
2025-03-01
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Mild cognitive impairment due to Alzheimer's disease

Interventions

Control group:Basic treatment + Shenghui decoction placebo
Treatment group:Basic treatment + Shenghui decoction granules

Sponsors

The First Affiliated Hospital of Henan University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
55 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Age 55-80 years old (including 55 and 80 years old) gender is not limited; (2) meet the diagnostic criteria of MCI Western medicine; (3) Cranial MRI showed atrophy of the hippocampus entorhinal cortex and other parts; (4) Meet the TCM syndrome type diagnostic criteria for MCI with heart and kidney deficiency; (5) 18 points= MoCA scale score<26 points; (6) Hachinski Ischemia Scale (HIS) score= 4 points; (7) Hamilton Depression Rating Scale (HAMD-17 items) score = 24 points; (8) Have the ability to read write and communicate at the time of screening and be able to cooperate with the completion of the neuropsychological assessment specified in the program; (9) Have a stable caregiver who can accompany the subject to the study visit. (10) The subject voluntarily participates in the clinical trial and signs the informed consent form. Those who meet the above conditions at the same time can be selected.

Exclusion criteria

Exclusion criteria: (1) Dementia caused by any cause other than AD including but not limited to: (1) Subjects suffering from other organic diseases such as: vascular dementia Huntington's disease Parkinson's disease frontotemporal dementia Creutzfeldt-Jakob disease amyotrophic lateral sclerosis dementia with Lewy bodies subdural hematoma hydrocephalus cerebral contusion cerebral malacia central nervous system infection (syphilis AIDS encephalitis meningitis) neuromyelitis optica intracranial space-occupying lesions (subdural hematoma brain tumor etc.); (2) Have suffered from major physical diseases in the past such as: hepatic encephalopathy pulmonary encephalopathy dialysis encephalopathy hypoxic encephalopathy etc.; (3) Dementia caused by other physical and chemical factors such as drug poisoning alcohol poisoning carbon monoxide poisoning etc.; (4) As judged by the investigator the subject suffers from mental illness such as major depression (Hamilton Depression Rating Scale score = 25 points) epilepsy schizophrenia etc.; (5)

Design outcomes

Primary

MeasureTime frame
ADAS-cog;

Secondary

MeasureTime frame
Montreal Cognitive Assessment;TCM Syndrome Scale;Activities of Daily Living Scale;Mini-Mental State Examination;Digital Breadth Test;

Countries

China

Contacts

Public ContactZhangJie

The First Affiliated Hospital of Henan University of Chinese Medicine

jie830@163.com13939026891

Outcome results

None listed

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