Clinical Study on Safety and Effectiveness of Ukgansan ga jinpibanha(herb medicine) for Insomnia

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0002521

Enrollment

Registered

2017-11-03

Start date

2017-09-29

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : I : Ukgansan ga Jinpibanha II : Ukgansan ga Jinpibanha placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: ? 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.

Design outcomes

Primary

Measure	Time frame
sleep efficiency (WASO: Wake After Sleep Onset)	—

Secondary

Measure	Time frame
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)	—

Countries

Korea, Republic of

Contacts

Public ContactNarae Yang

Catholic Kwandong University International St.Mary's Hospital

synthe222@gmail.com+82-32-290-3318

Outcome results