Skip to content

Construction and promotion of digital therapy TCM brain health intervention platform: A prospective, multicenter, double-blind, double-analog, randomized controlled trial of "Yizhi Tongluo Fang" combined with cognitive digital therapy in the treatment of mild cognitive impairment (renal deficiency and blood stasis syndrome)

Construction and promotion of digital therapy TCM brain health intervention platform: A prospective, multicenter, double-blind, double-analog, randomized controlled trial of "Yizhi Tongluo Fang" combined with cognitive digital therapy in the treatment of mild cognitive impairment (renal deficiency and blood stasis syndrome)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112388
Enrollment
Unknown
Registered
2025-11-13
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

mild cognitive impairment

Interventions

Treatment group of Yizhi Tongluo combined with cognitive digital therapy:Yizhi Tongluo prescription treatment with cognitive digital therapy
YiZhiTongLuoFang treatment group:Yizhi Tongluo prescription treatment with fake cognitive digital therapy
Cognitive digital therapy treatment group:Cognitive digital therapy with placebo
Placebo control group:Placebo combined with false cognitive training

Sponsors

Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged between 40 and 80 years; 2. Reported cognitive decline in memory or other cognitive domains by the patient or caregiver lasting at least 3 months; 3. Mental status examination (MMSE) score >=20 (primary school) or >=24 (junior high school or above), Montreal Cognitive Assessment (MoCA) score =6 years; 5. Normal or mildly impaired activities of daily living.

Exclusion criteria

Exclusion criteria: 1. Diagnosed with any type of dementia; 2. Individuals with severe mental illness or neurodevelopmental delays; 3. Suffering from other neurological diseases that may impair brain function (such as epilepsy, intracranial tumors, Parkinson's disease, metabolic disorders, encephalitis, multiple sclerosis, traumatic brain injury, normal pressure hydrocephalus, etc.); 4. Cognitive impairment caused by other systemic diseases: such as liver dysfunction, renal dysfunction, thyroid disorders, severe anemia, folic acid and vitamin B12 deficiency, carbon monoxide poisoning, specific infections (such as syphilis, HIV), alcohol and drug abuse, etc.; 5. Severe kidney or liver disease, cancer, or serious illnesses; 6. Use of anti-dementia medications (such as cholinesterase inhibitors, NMDA receptor antagonists, etc.) and anti-vascular cognitive impairment drugs within the past month; 7. Unable to cooperate with completing digital therapy.

Design outcomes

Primary

MeasureTime frame
Montreal Cognitive Assessment ;

Secondary

MeasureTime frame
Minimum Mental State Examination;Auditory Verbal Learning Test;Boston Naming Test;Trail Making Test-B;36-Item Short Form Survey;Patient Health Questionnaire-9;Symptom scoring in traditional Chinese medicine;

Countries

China

Contacts

Public ContactLi Qianqian

Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University

hydgwxy@126.com+86 185 0022 5944

Outcome results

None listed

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