The exploratory study of Yokukansankachimpihange on BPSD in patients with DLB.
Not Applicable
- Conditions
- DLB patients with BPSD
- Registration Number
- JPRN-jRCT1080222763
- Lead Sponsor
- Tsumura & Co.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 20
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method europsychiatric inventory (NPI) total score <br>Changes in NPI total score before and after Yokukansankachimpihange treatment
- Secondary Outcome Measures
Name Time Method PI subscale score <br>Changes in NPI subscale score before and after Yokukansankachimpihange treatment