ITMCTR2000003666招募中1 期
Multi-Center RCT study of Tengzhang Tongluo Decoction in precise treatment of cerebral small vessel disease
Shanghai Yueyang Integrated Traditional Chinese Medicine and Western Medicine Hospital0 个研究点开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 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
- 性别
- All
入选标准
- •1. Aged 18-80 years;
- •2. The imaging performance on 3.0T-MRI conforms to the definition of CSVD in the 2013 international STRIVE standard, including any of the new subcortical small infarcts, lacuna, white matter hyperintensity, microhemorrhage, and brain atrophy One kind.
- •3. The mRS score at the time of visit was 0-2.
- •4. Sign the informed consent form, willing and able to independently cooperate with the assessment of cognition and other related scales, gait assessment, collection of blood samples, follow-up imaging examination, and medication.
排除标准
- •1. Meet the diagnosis of lacunar syndrome but within 6 months of onset (to avoid the impact of acute phase).
- •2. Brain MRI SWI sequence indicated >=5 microbleeds.
- •3. Intracranial and external vascular examination confirmed vascular stenosis >=50%.
- •4. Imaging data revealed the presence of intracranial space-occupying lesions.
- •5. Other neurological diseases or psychiatric diseases that have been diagnosed with a clear cause in the past: mainly include stroke (except lacunar infarction), Parkinson's disease, Alzheimer's disease, autoimmunity, metabolism, poisoning-related intracranial diseases , Central nervous system infection, head trauma, hydrocephalus (except for brain atrophy), schizophrenia.
- •6. Previously diagnosed cardiovascular events (including myocardial infarction, angina pectoris, previous internal carotid endarterectomy or internal carotid artery stent placement, coronary stent placement, coronary artery bypass surgery)
- •7. Suffer from other serious diseases at the same time (such as malignant tumor, heart failure, respiratory failure, renal failure and severe liver damage, severe blood system disease or gastrointestinal bleeding).
- •8. There is severe impairment of vision, hearing, and language, or poor muscle strength and unable to cooperate with the completion of related examinations.
- •9. There are clear contraindications or adverse reactions to the drug components.
- •10. Are taking drugs that improve or affect cognitive function or taking other TCM drugs within 1 month.
- •11. Within 1 month or currently undergoing clinical trials of other drugs.
- •12. Surgery is planned within 1 year.
- •13. Pregnant or lactating women.
- •14. The collection of clinical data conforming to the analysis of this study cannot be completed for various other reasons.
研究者
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