UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021562 |
|---|---|
| Receipt number | R000024863 |
| Scientific Title | Exploratory study for the efficacy and safety of Sansoninto on behavioral and psychological symptoms of dementia (BPSD) in patients with Dementia.: Multicenter trial |
| Date of disclosure of the study information | 2016/03/22 |
| Last modified on | 2021/09/25 11:37:27 |
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Basic information
Public title
Exploratory study for the efficacy and safety of Sansoninto on behavioral and psychological symptoms of dementia (BPSD) in patients with Dementia.: Multicenter trial
Acronym
The efficacy and safety of Sansoninto on behavioral and psychological symptoms of dementia (BPSD) in patients with Dementia
Scientific Title
Exploratory study for the efficacy and safety of Sansoninto on behavioral and psychological symptoms of dementia (BPSD) in patients with Dementia.: Multicenter trial
Scientific Title:Acronym
The efficacy and safety of Sansoninto on behavioral and psychological symptoms of dementia (BPSD) in patients with Dementia
Region
| Japan |
Condition
Condition
Dementia patients with BPSD
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate exploratively the efficacy and safety of Sansoninto on behavioral and psychological symptoms of Dementia in a single-armed, open-label study.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in neuropsychiatric inventory (NPI) score before and 4 weeks after sansonintotreatment
Key secondary outcomes
Changes in neuropsychiatric inventory (NPI) subscale before and 4 weeks after Sansoninto treatment
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
sansoninto for 4weeks
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Diagnosed to be dementia
2) Within normal limit of serum potassium.
3) HDS-R under 20
4) Agreement to sign an informed consent.
Key exclusion criteria
1) Patient who has an allergy to Sansoninto medicine.
2) Patients considered inappropriate by the study investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiko Ogawa |
Organization
Kanazawa University
Division name
Department of Kampo Medicine
Zip code
Address
13-1,Takara-machi, Kanazawa
TEL
076-265-2918
okeiko@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazumi Hirata |
Organization
Kanazawa University Hospital
Division name
Department of Kampo Medicine
Zip code
Address
13-1, Takara-machi, Kanazawa
TEL
076-265-2918
Homepage URL
tomato.j2364832@gmail.com
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Kanazawa University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
金沢大学附属病院、映寿会みらい病院、田中町温泉病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2016 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 25 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 22 | Day |
Last modified on
| 2021 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024863
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
