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Evidence research based evaluation of zhinaoshen in the treatment of mild cognitive impairment

Evidence research based evaluation of zhinaoshen in the treatment of mild cognitive impairment

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200057884
Enrollment
Unknown
Registered
2022-03-20
Start date
2022-03-31
Completion date
Unknown
Last updated
2023-11-21

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

Conditions

mild cognitive impairment

Interventions

Control group:basic disease treatment + placebo
Placebo twice a day, 3 tablets after meal
Treatment group:basic disease treatment + zhinaoshen (tablet)
Zhinaoshen tablet twice a day, 3 tablets after meal

Sponsors

Xiyuan Hospital of China Academy of Chinese Medical Science
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age = 40 years and = 80 years; 2. The ability of daily living is normal, that is, the ADL score is = 18 points; 3. Impaired objective cognitive function: the cut-off value of the Montreal cognitive assessment basic (MoCA-B) is: education background less than 6 years, = 19 points; Education background: 7-12 years, = 22 points; Education background of more than 12 years, = 24 points; 4. No dementia, that is, the overall decline scale (GDS) is rated as 2-3; 5. TCM syndrome differentiation is Qi deficiency and blood stasis syndrome; 6. The Chinese and western medicine therapy was not regularly applied to cognitive function in recent 2 months; 7. Informed consent and voluntary participation.

Exclusion criteria

Exclusion criteria: 1. Hypertension patients with uncontrollable blood pressure (systolic blood pressure greater than 160mmHg or diastolic blood pressure greater than 100mmHg); 2. Have a history of alcohol and drug abuse; 3. Have a history of mental illness (such as personality disorder, schizophrenia, etc.), or suffer from severe aphasia and audio-visual disorder, or severe organ failure, myocardial infarction, coronary heart disease, musculoskeletal system disease, and other sports contraindications; 4. Cognitive impairment caused by depression, namely, the Elderly Depression Scale (ODS) = 11 points; 5. People with cognitive impairment caused by drugs or poisoning; 6. Oral antibiotics, probiotics and/or prebiotics within 1 months; 7. Other clinical trials who are participating in the evaluation of the research results; 8. Pregnant women.

Design outcomes

Primary

MeasureTime frame
(Montreal Cognitive Assessment;Alzheimer's disease rating scale;

Secondary

MeasureTime frame
Activity of daily living rating scale;

Countries

China

Contacts

Public ContactLinjuan Sun

Xiyuan Hospital of China Academy of Chinese Medical Science

sunlinjuan888@163.com+86 13699279549

Outcome results

None listed

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