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Clinical Trial of Yizhi Annao Granule treatment in Vascular Cognitive Impairment based on Disease-collaterals theory

Clinical Trial of Yizhi Annao Granule treatment in Vascular Cognitive Impairment based on Disease-collaterals theory

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IIR-17012422
Enrollment
Unknown
Registered
2017-08-19
Start date
2017-08-22
Completion date
Unknown
Last updated
2017-08-21

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

Conditions

vascular cognitive impairment

Interventions

Yizhi Annao Granule treatment group:Yizhiannao Granule

Sponsors

The First Affiliated Hospital of Anhui University of traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 80 Years

Inclusion criteria

Inclusion criteria: Consistent with DSM-V or NINDS-AIREN established may be the diagnosis of VaD and vascular cognitive impairment in patients; (1) Hachinski ischemic scale (HIS) score> 4; (2) MRI examination of acute stage of cerebral infarction, recovery period evidence; (3) study into the patient must be within six months of stroke; (4) MMSE baseline score between 11-26 points, in line with light to moderate; (5) weight between 45-90kg; (6) aged 45 to 80 years, men and women; (7) voluntary participation in this trial and signed informed consent; (8) have a certain degree of education, previously able to read simple articles and write simple sentences.

Exclusion criteria

Exclusion criteria: (1) primary dementia, early manifestations of memory impairment, progressive increase, accompanied by other cognitive impairment such as aphasia, loss, loss of consciousness, and the lack of relevant brain imaging of focal lesions; (2) there was no focal neurological signs except for cognitive impairment; (3) No autosomal dominant arterial disease (CADASIL) of hippocampal volume or medial temporal lobe atrophy, or cerebral hemorrhagic dementia and subcortical arteriosclerotic encephalopathy or subcortical infarct and leukoencephalopathy were detected by CT or MRI; (4) Hachinski ischemic scale (HIS) score=4; (5) Hamilton Depression Rating Scale (HAMD) score> 17 points, or depression patients, or patients with other psychiatric or mental disorders; (6) Other patients with secondary dementia, depressive dementia, psychomotor excitation, psychotic episodes, epilepsy, and patients with acute or poorly controlled disease are excluded from the income spectrum; (7) suffering from certain diseases that interfere with cognitive function assessment, including alcohol consumption, or drug abuse or other psychotropic substance abuse in the past five years; (8) with severe neurological deficits that can not complete the examination, such as hand hemiplegia, a variety of aphasia, audio-visual disorders; (9) in the past 30 days have been treated with similar drugs, such as taking related or antagonistic drugs, the efficacy of drugs is difficult to judge. With other research medication, psychotropic drugs, psychotropic side effects of drugs, oral anticoagulant and medication history of patients with blood circulation, short-acting diazepam application; (10) patients undergoing cardiac pacemaker surgery, coronary intervention and coronary artery bypass surgery, with intra-articular magnetic implants, who can not undergo magnetic resonance imaging; (11) of the test drug allergy; (12) to participate in other clinical drug trial.

Design outcomes

Primary

MeasureTime frame
Alzheimer's disease assessment scale, ADAS-cog;Verbal Fluency Test;Trail Making Test;Stroop Color-word Test;Clock Drawing Test;HVLT-R;Symbol Digit Modalities Test;rs-fMRI;white matter structural integrity;

Secondary

MeasureTime frame
Mini-Mental Status Examination;activity of daily living;NIH Stroke Scale;

Countries

China

Contacts

Public ContactDaojun Xie

The First Affiliated Hospital of Anhui University of traditional Chinese Medicine

daojunxie81@163.com+86 0551-62838661

Outcome results

None listed

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