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Effects of a traditional Japanse herbal medicine yokukansan (YKS) for BPSD in DLB

Effects of a traditional Japanse herbal medicine yokukansan (YKS) for BPSD in DLB - Yokukansan for DLB

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001511
Enrollment
60
Registered
2008-11-20
Start date
2006-08-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Dementia with Lewy bodies (DLB), Parkinson disease with dementia (PDD)

Interventions

Four weeks of conventional dose of YKS treatment

Sponsors

yokukansan-DLB research group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Probable DLB patients diagnosed according to the international consensus criteria for DLB. Parkinson's disease (PD) with dementia is also included. 2.Patients with 4 or more points at least one subscale of NPI 3.Serum potessium is within normal limit.

Exclusion criteria

Exclusion criteria: 1.Malignancy 2.Severe life-thretning disease such as heart, liver, renal, blood diseases. 3.Other type of dementia i.e. Alzheimer disease, vascular dementia, FTD. 4.Neurodegenerative disease other than DLB or PD. 5.Other mental disorders such as depression, bipolardisorder,schizophrenia. 6.Hallucination due to alcohol abuse, drug abuse and / or other reasons 7. Use of neuroleptics (i.e. fluphenazine, haloperidol) within rescent 4 weeks. 8.Diagnosed as inadequate by the physician in charge

Design outcomes

Primary

MeasureTime frame
Neuropsychiatric Inventry at baseline and after 2 and 4 weeks of YKS treatment.

Secondary

MeasureTime frame
MMSE, DAD, BEHAVE-AD, Zarit score, Fluctuation, biochemistry data at baseline and 4 weeks treatment

Countries

Japan

Contacts

Public ContactShinji Ioka

Tsumura & Co. Devision of medical research

ioka_shinji@mail.tsumura.co.jp03-6361-7185

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026