KCT0007039招募中未知
The Efficacy of Kami Guibi-tang for Improving Cognitive Function in Mild Cognitive Impairment Patients : A Randomized, Double-blind, Placebo-controlled Trial
Kyung Hee University Oriental Medicine Hospital at Gangdong0 个研究点目标入组 84 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 84
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
- 55?(Year) 至 90?(Year)（—）
- 性别
- All
入选标准
- •1. Those aged 55-90 who were diagnosed with amnestic mild cognitive impairment (aMCI) by a neurologist through the Seoul Neuropsychologic Screening Battery(SNSB) based on the diagnostic criteria for MCI suggested bt Albert et al.
- •- GDS(Global Deterioration Scale) = 3
- •- CDR (Clinical Dementia Rating) = 0.5
- •2. Those who have not received cognitive-related medication within the last 2 weeks
- •- cognitive-related medication : Cerebral blood flow improvement agents such as gliatirin and tanamine, and other brain nutrients, which may affect brain cognition.
- •- Also excludes taking dementia treatments such as donepezil, rivastigmine, and gallantamine.
- •3. Those who have been stable for the past 2 weeks or more without any change in the drug used for the underlying disease, and who are planned to be stable during this clinical trial.
- •4. Those who have no problem with communication
- •5. Those who do not qualify for disqualification related to MRI(magnetic resonance imaging).
排除标准
- •1. Those who diagnosed with dementia by NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke and Alzheimer's Disease and Related Disorders Association)
- •2. Those who diagnosed as vascular cognitive impairment by NINDS-AIREN
- •3. Those with brain disorders that cause other neurological symptoms other than cognitive dysfunction
- •4. Patients with degenerative brain disease such as Parkinson's disease, Huntington's chorea, Down syndrome, and Creutzfeldt-Jakob disease on history and neurological examination
- •5. Cerebral trauma due to hypoxia such as cerebral trauma and carbon monoxide poisoning, vitamin deficiency, infectious diseases such as neurosyphilis or encephalitis, brain tumor, endocrine metabolic disease, mental retardation
- •6. If there is evidence of clinically evident cerebrovascular disease, or if there is suspicion of a territorial infarct of cerebral blood vessels due to multiple strokes on MRI(magnetic resonance imaging)
- •7. Patients with a history of convulsive disease (except for febrile convulsions in childhood)
- •8. Those with a history of depression or who are currently suffering from depression
- •9. Those with mental illness or who have behavioral problems requiring psychotropic medication
- •10. Those who have substance abuse (drug addiction, alcoholism, etc.).
- •11. Persons with physical disabilities that cause life threatening and require immediate treatment.
- •12. Patients with uncontrolled hypertension
- •13. Patients with Heart or kidney disease
- •14. Patients with edema
- •15. Those with gastrointestinal symptoms (anorexia, stomach discomfort, nausea, abdominal pain, diarrhea, etc.)
- •16. Those who are taking medications that may cause hypokalemia or myopathy.
- •17. Persons with hypersensitivity to the components of clinical trial medicines
- •18. Those with possible pregnancy
- •19. Patients with clinically significant abnormalities in blood chemistry (SGPT/ SGOT : more than 2 times the normal upper limit, serum creatinine: 10% of the normal upper limit)
- •20. Those who participated in other clinical trials within 4 weeks(or Longer than 5 times the half-life of clinical trial drugs).
- •21. An illiterate participant
- •22. Other patients who were deemed inadequate by the tester
研究者
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