Exploratory Study on the Safety and Effectiveness of Yizhi Qingxin Decoction (Capsules) in the Treatment of Hypertension in the Elderly With Mild Cognitive Impairment (Deficiency of Kidney Essence Syndrome)
- Conditions
- Elderly hypertension with mild cognitive impairment
- Registration Number
- ITMCTR2000003062
- Lead Sponsor
- Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
(1) Meet the diagnostic criteria for elderly hypertension.
(2) Meet the MCI diagnostic criteria.
(3) Comply with the dialectical standard of kidney essence deficiency deficiency of traditional Chinese medicine.
(4) Aged 65-75 years;
(5) Adequate vision and hearing department to undergo neuropsychological tests;
(6) Have a certain level of education and can read and write simple sentences;
(7) Sign the informed consent
(1) Dementia of various causes, including AD, VaD, or other types of dementia, that have met the DSM-IV diagnostic criteria for dementia, such as Parkinson's disease, Huntington's disease, normal pressure hydrocephalus, brain tumors, progressive supranuclear palsy, epilepsy, chronic hard sub-membrane hematoma and multiple sclerosis, with a history of severe head trauma with persistent neurological deficits or known brain structural abnormalities;
(2) Sleep disorders that may affect cognitive performance, drug or alcohol abuse or dependence in the previous 5 years, and other can interfere with factors that affect cognitive performance such as depression (HAMD> 12 points) or mental disorders;
(3) CT or MRI scans in the past 12 months show central nervous system infection, infarction, and other focal damage;
Heikinski Ischemic Scale (HIS)> 4 points;
(4) Other conditions that should not be participated in this study, such as hypertension emergency, hypertension crisis, and drug taking controlled hypertension, severe arrhythmia, or cardiac function grade 3-4, or myocardial infarction occurred within 3 months before participating in the trial, etc .;
(5) Chinese medicine, anticholinergic, anticonvulsant, antiparkinsonian, excitatory, cholinergic, antipsychotic, or anticholinergic or cholinergic antidepressant or anxiolytic of patients, known to be allergic to this medicine;
(6) Severe liver and kidney dysfunction, such as ALT or AST above 1.5 times the normal value, or the upper limit of serum Cr normal value;
(7) Severe asthma and chronic obstructive pulmonary disease;
(8) Patients with severe indigestion, gastrointestinal obstruction, gastric or duodenal ulcers;
(9) Those who are participating in other clinical trials;
(10) Subjects that the investigator believes cannot follow the study procedure.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Conversion rate of dementia;
- Secondary Outcome Measures
Name Time Method 24h ambulatory pressure;Montreal cognitive assessment scale;mini-mental state examination;Syndrome change overall impression scale;ADCS-MCI-ADL-24;