Post marketing clinical trial of TJ-54

Post marketing clinical trial of TJ-54 for patients who have neuropsychiatric symptoms of Parkinson`s disease

Status

Unknown

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1080220598

Enrollment

Registered

2008-08-27

Start date

2008-08-27

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

Neuropsychiatric symptoms of Parkinson`s disease

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients with NPI subscale score of 4 points or greater on more than one subscale 4 weeks prior to and at the start of treatment 2.Patients with MMSE (Mini-Mental State Examination) score of 24 points or greater 4 weeks prior to and at the start of treatment

Exclusion criteria

Exclusion criteria: 1.Patients who are diagnosed with dementia based on DSM-IV criteria [Diagnostics and Statistical Manual of Mental Disorders, 4th Edition] 2.Patients with serious complications(heart, liver, or kidney dysfunctions, hematopoietic disorders, malignant tumors, etc.) and other life-threatening diseases.

Design outcomes

Primary

Measure	Time frame
NPI(Neuropsychiatric Inventory) 4,8 and 12 weeks after the treatment	—

Secondary

Measure	Time frame
UPDRS subscale3,Hoehn-Yahr 4,8 and 12 weeks after the treatment	—

Outcome results

None listed

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