Clinical Study on Safety and Effectiveness of Ukgansan ga jinpibanha(herb medicine) for Insomnia
- Conditions
- Mental and behavioral disorders
- Registration Number
- KCT0002521
- Lead Sponsor
- Catholic Kwandong University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
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.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method sleep efficiency (WASO: Wake After Sleep Onset)
- Secondary Outcome Measures
Name Time Method PSQI (pittsburgh sleep quality index), ISI (Insomnia severity index), K-MMSE (Korean version of Mini Mental State Examination), K-IADL (Korean Instrumental Activities of Daily Living), ADAS-cog (Alzheimer`s Disease Assessment Scale-cognitive subscale), NPI(Neuropsychiatric inventory)