Clinical Study on Safety and Effectiveness of Ukgansan ga jinpibanha for Insomnia : safety and effectiveness (A randomized controlled, double-blind, parallel study, pilot study)

Catholic Kwandong University0 个研究点目标入组 30 人开始时间: 待定最近更新: 2019年3月11日

适应症

试验速览

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•inclusion criteria
•?age >50yrs. have some difficulty in sleep quality
•?diagnosed by Alzheimer disease based on DSM-?
•?score of K-MMSE is over 12, under 26 on screening test
•?taking Choline esterase inhibitor - Donepezil 5-23mg, Galantamine 8-24mg, Rivastigmine 3mg-12mg (patch : 5-15mg)
•?who could undertaking cognition test
•?decided to pativipated and agreed on paper agreement
•?have caregiver

•? underlying diseases including stroke or other central nerve disease cause
•? intaking any other medicine for dementia in 3months
•? any abnormal findinng on screening test
•a) AST, ALT> 3 times of normal range
•b) Hb < 8mg/dl or platelet < 100000/mm3
•c) serum creatinine > 3times of normal range or acute and chronic renal failure
•d) abnormal findings on vitamine B12, TPPA, TSH (it could influence on dementia ) ? ??? ?? 2? ??? ???????, ?????, ????, ???????? ??? ??
•? a history of angina pectoris, cardiac infarction, TIA or CBAG in 6 months
•? a history of concussion on head with loose of consciousness in 6 months
•? a history of psychotic disorder such as severe depression, schizphrenia, alcholism, drug dependence.
•? a history of parkinsonism need drug treat
•? have hypersenstivities on this drug
•? sevre hearing impairment and visual impairment or literacy so that cant answer the questionaaire.
•? a history of taking other clinical trial drug in 3 months
•? any abnormal findings that might possibly have impacted the study results.

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