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临床试验/ITMCTR2100005393
ITMCTR2100005393招募中1 期

A randomized, blind and controlled study of tonifying kidney, invigorating spleen and reducing phlegm in the treatment of amnestic mild cognitive impairment

Beijing Friendship Hospital, Capital Medical University0 个研究点开始时间: 待定最近更新:
适应症

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研究概览

简要总结

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研究设计

研究类型
Interventional study

入排标准

年龄范围
18 至 85(—)
性别
All

入选标准

  • (1) Meet the diagnostic criteria of mild cognitive impairment in this study;
  • (2) The chief complaint was memory loss, which was confirmed by the surrounding people;
  • (3) Aged between 45 and 85;
  • (4) The MMSE ranged from 24 to 30 points;
  • (5) age-inconsistent objective memory decreased, and delayed recall score of logical story recall was 1.5 SD (SD) to 2SD (SD) smaller than that of age or education matched group.
  • (6) The ability of daily living is basically normal, and the severity of dementia is not up to the diagnostic criteria;
  • (7) Heginsky ischemia Scale (HIS) score was 7 or less;
  • (8) Hamilton Depression Scale (HAMD) score of 12 or below;
  • (9) The standard of TCM syndrome diagnosis is pES-11, namely, at least one of the three syndromes of kidney eficiency, spleen deficiency and phlegm turbidity =7 points;
  • (10) Have a certain degree of education, can read simple articles, write simple sentences;
  • (11) Adequate hearing and vision assessment;
  • (12) Subjects and caregivers are willing to sign informed consent.

排除标准

  • (1) The presence of any neurological disease causing dementia, such as Parkinson's disease, multisystem atrophy, progressive supranuclear palsy, Huntington's disease, vascular dementia, normal pressure hydrocephalus, brain tumors, epilepsy, cerebral edema after cerebral hemorrhage before absorption or subarachnoid hemorrhage in the acute phase, chronic subdural hematoma and multiple sclerosis, A history of severe head trauma with persistent neurological deficits or known brain structural abnormalities;
  • (2) The presence of clinically uncontrolled cardiovascular and cerebrovascular diseases, abnormal liver and kidney metabolism diseases, peptic ulcer active stage;
  • (3) Depressive state (HAMD>7), or other mental disorders;
  • (4) thyroid dysfunction, significant Vb12 or folic acid deficiency;
  • (5) had taken antipsychotic drugs within 72 hours before the neuropsychological assessment;
  • (6) Had taken sympathomimetic drugs, antihistamines, antianxiety drugs and diazepam within 48 hours before the neuropsychological assessment;
  • (7) History of alcohol addiction and abuse;
  • (8) Those who have serious neurological defects and cannot complete relevant examinations, such as convenient hand hemiplegia, various aphasia, audio-visual impairment, etc.

研究者

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