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A randomized, double-blind, multicenter clinical study on the treatment of vascular dementia with Shenxiong Qingnao Yizhi Formula

A randomized, double-blind, multicenter clinical study on the treatment of vascular dementia with Shenxiong Qingnao Yizhi Formula

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074164
Enrollment
Unknown
Registered
2023-08-01
Start date
2023-08-01
Completion date
Unknown
Last updated
2023-08-07

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

Conditions

vascular dementia

Interventions

test group:Take Shenxiong Qingnao Yizhi Formula and Donepezil
control group:Take placebo and Donepezil
healthy control group:No intervention

Sponsors

Shenzhen Traditional Chinese Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 74 Years

Inclusion criteria

Inclusion criteria: ? Complies with DSM-IV diagnostic criteria; Possible vascular dementia according to NINDS-AIREN critieria; ? Conforming to the diagnostic criteria of traditional Chinese medicine for dementia of qi deficiency, blood stasis, phlegm turbidity type, with symptom scores greater than 7 points; ? Conforming to the Folstein Mini Mental State Examination (MMSE-R) scoring criteria and the diagnostic criteria for vascular dementia: Hachinski Ischemia Scale (HIS score = 7 points); ? The age boundary is based on the standards established by the Geriatrics Professional Committee of the Chinese Medical Association in 1982: pre elderly and elderly patients = 45 years old and = 74 years old are included in the trial cases; ? Voluntary and signed informed consent form, with good compliance; ? No medication for treating dementia been taken within 2 weeks. Inclusion criteria for the healthy control group ? Match with demographic data such as gender, age, and education level in the vascular dementia group; ? Having good physical health and no previous serious physical illness; ? Mental examination, no previous psychiatric diagnosis or related family history; ? No contraindications for other MRI examinations such as claustrophobia;

Exclusion criteria

Exclusion criteria: ? Alzheimer's disease or dementia of other causes, or patients diagnosed with dementia from other causes according to DSM-IV criteria; ? Patients with HIS score177 µ Mol/L; Patients with diseases that can cause cognitive impairment such as tumors, AIDS, hyperthyroidism, and those with severe anemia; Patients with unstable metabolic disease control; Basic diseases include asthma or chronic lung disease Or patients with polyneuritis, Myasthenia gravis, muscular atrophy and other possible sudden asphyxia; Serious gastrointestinal diseases or diseases that affect drug absorption, such as severe indigestion, gastrointestinal obstruction, duodenal ulcer, etc; Patients with glaucoma or other conditions that affect visual function evaluation; Have a history of epilepsy, encephalitis, and related diseases that can lead to dementia, such as Huntington's disease and Parkinson's disease; Patients with cognitive disorders that interfere with evaluation, such as alcoholism, past drug abuse, and drug users; Patients with severe neurological deficits accompanied by impact assessment; Those whose heart rate is not between 50-110 beats per minute and have experienced heart diseases such as myocardial infarction and arrhythmia within 4 months; Patients with systolic blood pressure not within the range of 100-180 mm Hg in both sitting and lying positions; ? Patients aged less than 45 years old or with insufficient course of disease; ? Have a history of Drug allergy. Those who do not meet the inclusion criteria, do not use drugs according to regulations, cannot determine the efficacy, or have incomplete information that affects the efficacy or safety evaluation; ? Traditional Chinese Medicine Syndrome Differentiation SDSVD: Qi Deficiency, Blood Stasis, Phlegm Turbidity Syndrome Score < 7 points.

Design outcomes

Primary

MeasureTime frame
Montreal Cognitive Assesement, MoCA;adrenaline;dopamine;5-HT;

Secondary

MeasureTime frame
ADAS-cog;CDR;ADL;SDSVD;

Countries

China

Contacts

Public ContactQin Xiude

Shenzhen Traditional Chinese Medicine Hospital/The Fourth Clinical Medical College of Guangzhou University of Chinese Medicine

qinxiude@foxmail.com+86 135 3096 7138

Outcome results

None listed

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