ITMCTR2100004618已完成1 期
Clinical study on Prevention and treatment of Vascular dementia by invigorating spleen and Kidney, resolving phlegm and dredging collaterals
Shenzhen TCM Hospital0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 45 至 85（—）
- 性别
- All
入选标准
- •1.Age >= 50 years old and <= 85 years old.
- •2.Accorded with the diagnostic criteria of DSM-5 vascular neurocognitive impairment in western medicine, and conformed to the TCM syndrome type of spleen and kidney deficiency, phlegm and blood stasis blocking collaterals, the score of SDSVD syndrome was >= 7 points.
- •3.Clinical dementia scale (CDR) score >= 0.5,Montreal Cognitive Assessment scale (MoCA) score < 26; Hachinski Ischemia scale (HIS) score >= 7;
- •4. He hasn't taken any drugs for dementia in 42 weeks.
- •5. Voluntarily and sign informed consent, with good compliance.
排除标准
- •1.Dementia caused by Alzheimer's disease or other causes diagnosed by DSM-5 standard.
- •2. Patients with 2HIS score < 7; or patients with SDSVD score < 7.
- •3.Patients with severe mental disorders, or patients with HAMD-17 > 17.
- •4.Patients with severe medical diseases or severe neurological impairment, such as malignant tumors, various aphasia, visual and auditory disorders, etc.; patients with liver, kidney or heart diseases, including those with ALT or AST more than 3 times normal, cardiac function grade 2-4, serum creatinine (Scr) > 177 umol / L; patients with cognitive impairment, such as tumors, AIDS, hyperthyroidism, and patients with severe anemia. Patients with unstable control of metabolic diseases; patients with underlying diseases such as asthma or chronic lung disease, or patients with polyneuritis, myasthenia gravis and muscular atrophy who may have sudden asphyxia; patients with severe gastrointestinal diseases or diseases that affect drug absorption, such as severe dyspepsia, gastrointestinal obstruction, duodenal ulcer, etc.; patients with glaucoma that affect visual function evaluation. Have a history of epilepsy and encephalitis, and related diseases that lead to dementia, such as Huntington's disease, Parkinson's disease, etc.; patients who interfere with the evaluation of cognitive diseases, such as alcoholism, previous drug abuse and drug abusers; patients with severe neurological deficiency with impact evaluation; patients whose heart rate is not in the range of 50-110 beats / min and have developed heart diseases such as myocardial infarction and arrhythmia within 4 months. The systolic blood pressure of patients in sitting position and supine position was not in the range of 100-180 mm Hg.
- •5. The age of the patients is less than 50 years old, or the course of disease is not enough.
- •6. Those who had a history of drug allergy or participated in other drug trials within 2 months.
研究者
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