ITMCTR2000003954招募中1 期
Efficacy and safety of Yi Shen Fang granules in elderly people with MCI: a multicentre, randomized, double-blind, parallel-group, controlled trial
Shanghai Municipal Hospital of Traditional Chinese Medicine,Shanghai University of TCM0 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
- 年龄范围
- 60 至 —（—）
- 性别
- All
入选标准
- •1. Male and female participants aged >= 60 years;
- •2. Clear consciousness, normal hearing and visual abilities are maintained, and have the ability to participate in the neuropsychological activity test;
- •3. Participants meet diagnostic criteria for MCI in ICD-10 and should meet the following items at the same time:
- •1) The patient or insider subjectively feels that there is a decline in cognitive function;
- •2) Impaired cognitive function in objective examination;
- •3) The daily life function is basically normal;
- •4. It does not meet the diagnostic criteria of Dementia; The total score of Clinical Dementia Rating Scale (CDR) Chinese version was 0.0 to 0.5;
- •5. The total score of Montreal Cognitive Assessment (MoCA) Beijing version is below 26 (years of education < 12 years, MOCA score < 25);
- •6. Participants agree to sign the informed consent form and volunteer for this study.
排除标准
- •(1) Participants with a history of mental disorders such as dissociative disorder, obsessive-compulsive disorder, personality disorder, schizophrenia, bipolar disorder, severe depression disorder, anxiety disorder are excluded;
- •(2) Participants with a history of drug or alcohol dependence or drug allergies are excluded in this study;
- •(3) Participants were taking antipsychotic medication or medications that affect cognition;
- •(4) Participants with a history of head trauma resulting in loss of consciousness;
- •(5) Any participant on treatment were withdrawn from other clinical drug trials before the first study-drug administration were less than 4 weeks.
- •(6) Participants with serious gastrointestinal diseases (such as indigestion, gastrointestinal obstruction, gastroduodenal ulceration) and serious secondary diseases that affect drug absorption;
- •(7) Participants comprised hepatic and renal dysfunctionsevere neurological diseasescardiovascular and cerebrovascular diseases complication as well as a history of other autoimmune diseases and any other contraindication;
- •(8) Participants with scores of the 30-item version of the Geriatric Depression Scale (GDS-30) higher than 20.
- •(9) The Hamilton Anxiety Rating Scale (HAMA14-item version) score of >= 21 points.
研究者
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