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The exploratory study of Yokukansankachimpihange on BPSD in patients with DLB.

Exploratory study for the efficacy and safety of Yokukansankachimpihange on behavioral and psychological symptoms of dementia (BPSD) in patients with dementia with Lewy bodies.

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1080222763
Enrollment
20
Registered
2015-02-20
Start date
2015-02-20
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

DLB patients with BPSD

Interventions

investigational material(s) Generic name etc : TSUMURA Yokukansankachimpihange Extract Granules for Ethical Use INN of investigational material : Therapeutic category code : 52- Chinese medicines Dos

Sponsors

Tsumura & Co.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Probable DLB or possible DLB 2) Within normal limit of serum potassium. 3) Have a study partner able to provide an independent evaluation of functioning. 4) Agreement to sign an informed consent.

Exclusion criteria

Exclusion criteria: 1) Patients with neurological disease to affect the cognitive function except DLB. 2) Patients who have local lesion which affected the cognitive function by CT or MRI. 3) Patients with serious diseases such as malignant tumors, or disorder which is not in stable condition. 4) Patient who has an allergy to Kampo medicine. 5) Patients considered inappropriate by the study investigator.

Design outcomes

Primary

MeasureTime frame
Neuropsychiatric inventory (NPI) total score Changes in NPI total score before and after Yokukansankachimpihange treatment—

Secondary

MeasureTime frame
NPI subscale score Changes in NPI subscale score before and after Yokukansankachimpihange treatment—

Outcome results

None listed

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