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Construction and promotion of a digital therapy + TCM brain health intervention platform: cohort study of Yizhi Qingzhuo Yin intervention for mild congnitive impairment in multimorbid elderly patients

Construction and promotion of a digital therapy + TCM brain health intervention platform: cohort study of Yizhi Qingzhuo Yin intervention for mild congnitive impairment in multimorbid elderly patients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2025001629
Enrollment
Unknown
Registered
2025-09-01
Start date
2025-09-18
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

mild cognitive impairment

Interventions

Exposure Group:Patients for whom Yizhi Qingzhuo Yin (composed of: Polygonati Rhizoma [Huangjing] 5g, Mori Fructus [Sangshen] 5g, Lycii Fructus [Gouqi] 5g, Citri Reticulatae Pericarpium [Chenpi] 3g, Pu
Non-Exposure Group:Patients who did not receive Yizhi Qingzhuo Yin during the same period. Their chronic disease management plans-which could include other Chinese herbal medicines, Western pharmaceut
other Chinese herbal infusions for daily drinking (e.g., Jianpi Zishen Fang [Spleen-Fortifying Kidney-Nourishing Formula])
non-pharmacological interventions (e.g., dietary counseling, exercise guidance).

Sponsors

Medicine affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 100 Years

Inclusion criteria

Inclusion criteria: (1) Age = 50 years, regardless of gender; (2) Concurrent diagnosis of = 2 of the following chronic conditions: Hypertension, Diabetes mellitus, Hyperlipidemia, Coronary heart disease, Obesity (BMI = 28 kg/m²), Hyperuricemia, History of cerebral infarction or intracerebral hemorrhage (current modified Rankin Scale [mRS] score = 2), Non-advanced malignancy (non-stage IV, clinically stable, not requiring active chemotherapy/radiotherapy); (3) Meet the core clinical criteria for Mild Cognitive Impairment (MCI) as defined in the 2018 Chinese Guidelines for the Diagnosis and Treatment of Dementia and Cognitive Disorders (V): Diagnosis and Treatment of Mild Cognitive Impairment; (4) Self-reported and/or informant-reported cognitive decline within the past 6-12 months, with preserved or largely preserved independence in basic activities of daily living (e.g., assessed by the Activities of Daily Living [ADL] scale); (5) Neuropsychological assessment confirming: Montreal Cognitive Assessment (MoCA) score = 26; (6) Education level = 6 years; (7) Able to communicate effectively in Mandarin Chinese; (8) Willing to participate in the study, provide written informed consent, and able to comply with scheduled follow-up assessments.

Exclusion criteria

Exclusion criteria: (1) Cognitive impairment attributed to a clearly identified cause other than MCI (e.g., dementia, Parkinson's disease dementia, brain tumor, sequelae of encephalitis, etc.); (2) Severe systemic illness: End-stage organ failure; Active malignancy; (3) Acute exacerbation of psychiatric disorders (e.g., major depressive episode, unremitted schizophrenia); (4) Severe sensory/motor impairment precluding participation in assessments (e.g., blindness, deafness, aphasia, hemiplegia); (5) Chronic use of medications known to impair cognition (e.g., benzodiazepines, potent anticholinergics) that cannot be adjusted.

Design outcomes

Primary

MeasureTime frame
Total and domain-specific scores of the Montreal Cognitive Assessment;

Secondary

MeasureTime frame
Mini-Mental State Examination Total Score;Short Form 36 Health Survey Summary Scores;Physical/Mental Domain Score;Blood Pressure Value;Glycated Hemoglobin, HbA1c;Low-Density Lipoprotein Cholesterol, LDL-C;Body Mass Index, BMI;Serum Uric Acid, SUA;

Countries

China

Contacts

Public ContactYizhan Wang

Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University

wangyizhancn@126.com+86 153 1136 8116

Outcome results

None listed

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