KCT0006787尚未招募未知
A 24-week randomized double-blind, placebo-controlled, single-center investigator initiated trial to evaluate the efficacy and safety of Cheonwangbosimdan(Soonsimhwan) on mild cognitive impairment
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 48
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 85(Year)（—）
- 性别
- All
入选标准
- •1. participants(males and females) aged 55 to 85
- •2. participants who meet the Peterson diagnostic criteria for MCI, with memory impairments for at least 3 months
- •3. Score in Global Deterioration scale(GDS) was 2 or 3
- •4. Score in K-MMSE was 20-23
- •5. Score in MoCA-K was 0-22
- •6. Score in Geriatric Depression scale(GDS) was 0-18
- •7. fluency in language sufficient to reliably complete all study assessment
- •8. voluntarily signed the informed consent form.
排除标准
- •1. diagnosed with Alzheimer's Disease according to the NINCDS-ADRDA or diagnosed with vascular dementia according to the NINDS-AIREN
- •2. history of brain structure lesions which may cause cognitive impairment(e.g., traumatic brain injury, stroke, intracranial space-occupying lesions, congenital mental retardation)
- •3. serious disease conditions (e.g., cancer, kidney, liver, cardiovascular , and central nervous system diseases, Parkinson's disease, Huntionton disease, and Multiple sclerosis) ; a history of brain lesions confirmed on Brain CT or MRI within 12 months
- •4. who had been treated with alcohol or drug dependency, mental diseases(e.g., schizophrenia, serious anxiety, and depression) in the past six months
- •5. current treatment for MCI, such as medication, cognitive training, or Koean medicine treatment within 4 weeks before screening
- •6. who have difficulties in assessment due to visual and hearing impairments
- •7. impaired hepatic function(ALT (GPT) or AST (GOT) is at least twice the normal upper limit of the performing center)
- •8. impaired renal function(creatinine is at least twice the normal upper limit of the performing center)
- •9. the hypertensive patient (170/100mmHg or greater) or the diabetic patient (over 180mg/dl of fasting blood glucose)
- •10. ineligibility for participation in the trial because of a history of gastrointestinal diseases, anorexia, nausea, and vomit that might affect the absorptionj of the trial medication, as judged by the principal investigator
- •11. Women who are pregnant or breastfeeding
- •12. a history of hypersensitivity to the components of the trial medication
- •13. participation in other clinical trials within 4 weeks of screening for the present study or concurrent participation in other clinical trials
研究者
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