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The curative effect, mechanism and macro-micro-meso standard establishment of the precise treatment "Reyu Duju, Maizhi Luobi" of cerebral small vessel disease

The curative effect, mechanism and macro-micro-meso standard establishment of the precise treatment "Reyu Duju, Maizhi Luobi" of cerebral small vessel disease

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003912
Enrollment
Unknown
Registered
2020-09-08
Start date
2020-10-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

cerebral small vessel disease

Interventions

Sponsors

Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) The imaging performance on MRI includes one of the following manifestations: recent small subcortical infarcts, lacuna, white matter hyperintensity, microhemorrhage,brain atrophy and enlarged perivascular spaces. (2) Meet the "heat depression poison gathering" "Pulse stagnation" syndrome of traditional Chinese medicine diagnostic standards in the early stage of cerebral small vessel disease. (3) Aged 18-80 years, male or female. (4) Understand, agree to participate in this study and sign an informed consent.

Exclusion criteria

Exclusion criteria: (1) Large cerebral artery stenosis >= 50%. (2) Any hearing or visual impairment that can disturb efficient cognitive evaluation of the patient. (3) Massive cerebral infartion from cardioembolic source. (4) Any other white matter disease (i.e., multiple sclerosis, metabolic encephalopathy,toxic encephalopathy or multiple intracranial vasculitis). (5) Severe osteoarthritis and severe joint and muscle pain that may limit the patient's movement. Complicated with severe heart, liver, kidney, blood system and other diseases, or other serious primary diseases, mental illness. (6) Allergy to drugs in treatment programmes. (7) Pregnant or lactating women. (8) Patients who had participated in or were participating in other clinical trial the month before entering the group, or patients who had taken or were taking other medications for cerebral small vessel disease or Chinese herbal medicine with the same composition or the same effect as the tested Chinese herbal compound the month before entering the group.

Design outcomes

Primary

MeasureTime frame
TCM Syndrome Integr;ADL;tests for cognitive function;

Secondary

MeasureTime frame
glycometabolism;lipid metabolism;Microinflammation indicators;

Countries

China

Contacts

Public ContactYan Han

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

hanyan.2006@aliyun.com+86 18917510069

Outcome results

None listed

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