Evaluation of efficacy of yokukansan in patients with dementia with Lewy bodies using NPI-D as an indicator.
- Conditions
- Dementia with Lewy bodies
- Registration Number
- JPRN-UMIN000001832
- Lead Sponsor
- Department of Geriatric Medicine, Kyorin University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 20
Not provided
1) Patients with malignancy, severe disease of heart, liver, renal, blood, lung and other life-threatening diseases 2) Patients who fail to meet the DSM-IV diagnostic criteria for our study, but show symptoms of BPSD due to other concomitant neurodegenerative disease, schizophrenia, bipolar disorder, major depression or other psychiatric disorders 3) Patients with delirium due to alcohol or drug addictions, metabolic poisoning, or inflammatory disease 4) Patients who are unable to take oral medications 5) Patients initiated the therapy with donepezil hydrochloride or made change in dosage and administration of the drug within 8 weeks before the start of treatment 6) Patients received drugs prohibited for concomitant use or drugs restricted in concomitant use during wash-out period, 7) Patients who took long acting antipsychotic drugs (such as haloperidol decanoate) within 4 weeks before the start of treatment 8) Patients who are determined as unfit for the study by attending physicians for reasons other than those stated above
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method