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Vascular dementia treatment with Hengqing I formula: A multicenter randomized double-blind parallel place-controlled trial

Vascular dementia treatment with Hengqing?formula: A multicenter randomized double-blind parallel place-controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023170
Enrollment
Unknown
Registered
2019-05-15
Start date
2019-07-01
Completion date
Unknown
Last updated
2019-05-20

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

Conditions

vascular dementia

Interventions

Experimental group:Hengqing I formula
Nimodipine group:Nimodipine tablet

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: The diagnosis of vascular dementia by American psychiatric diagnostic and statistical manual (DSM-IV- R, 1994) diagnostic criteria of vascular dementia. Eligible participants should meet both the following items: Dementia: Firstly, pass through clinical examination and neuropsychological evaluation means, to determine the cognitive level of patients with a significant decline in the previous, including: (1) memory defects (unable to learn new information, or unable to recall previously mastered information); (2) cognitive field of two or more disorders: aphasia, apraxia (can not perform action, even if the patient does not have motor dysfunction), loss Recognize (cannot recognize or recognize objects, even if the patient does not have sensory dysfunction), executive management dysfunction (that is, planning, organization, abstraction, order, etc.); (3) the above two kinds of defects are not caused by cerebrovascular disease itself, but also has been very serious, affecting the patient's daily life, activity ability. Cerebrovascular disease: (1) confirmed by the nervous system examination, the patient has focal signs caused by cerebrovascular disease, including hemiplegia, blindness, sensory disorders, central facial paralysis, pathological signs; (2) no focal signs, but there is imaging examination (head CT or MRI) confirmed evidence of cerebrovascular disease, such as multiple large blood vessel infarction or a single key location of the infarction, as well as multiple base Basal ganglia and lacunar white matter infarcts, or extensive periventricular white matter damage, or coexistence of these lesions. The above two kinds of damage have causal relationship, that is, the existence of the following relationship:(2) or a sudden decline in cognitive function, or its cognitive impairment shows fluctuations like, ladder like damage. (1) meet the above criteria for diagnosis of dementia and mild to moderate clinical diagnosis; (2) the onset time of cerebrovascular disease was clear, imaging supported the diagnosis of infarction and hemorrhage, and dementia appeared within 3 months and lasted for 3 months; (3) Hachinski ischemia score (HDS score standard (3)) >=7; (4) except for dementia caused by other reasons.

Exclusion criteria

Exclusion criteria: (1) patients with alzheimer's disease (AD) or other types of dementia and severe VD; (2) patients with severe cardiac, pulmonary and renal dysfunction, severe diabetes mellitus and a history of mental illness; (3) those who have received systematic treatment of Chinese and western medicine in near past.

Design outcomes

Primary

MeasureTime frame
MoCA scale;Hasegawa dementia scale, HDS;HIS;Minimum Mental State Examination, MMSE;ADAS-Cog scale;Activity of Daily Living Scale, ADL;

Secondary

MeasureTime frame
serum total cholesterol;triglyceride;high density lipoprotein cholesterol;low density lipoprotein cholesterin;SDSVD;

Countries

China

Contacts

Public ContactShengxi Meng

Shanghai Sixth People's Hospital

mengsx163@163.com+86 18930170565

Outcome results

None listed

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