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

Phase 1

Recruiting

• Conditions: cerebral small vessel disease

• Registration Number: ITMCTR2000003912
• Lead Sponsor: Fudan University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

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

(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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TCM Syndrome Integr;ADL;tests for cognitive function;

Secondary Outcome Measures

Name	Time	Method
glycometabolism;lipid metabolism;Microinflammation indicators;