UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045650 |
|---|---|
| Receipt number | R000052113 |
| Scientific Title | Traditional Chinese medicine Jia Wei Gui Pi Tang for Behavioral and psychological symptoms of dementia (BPSD) and favorable positive emotions in demented patients. |
| Date of disclosure of the study information | 2021/10/22 |
| Last modified on | 2023/04/03 15:29:52 |
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Basic information
Public title
Traditional Chinese medicine Jia Wei Gui Pi Tang for Behavioral and psychological symptoms of dementia (BPSD) and favorable positive emotions in demented patients.
Acronym
Jia Wei Gui Pi Tang (JWGPT) trial
Scientific Title
Traditional Chinese medicine Jia Wei Gui Pi Tang for Behavioral and psychological symptoms of dementia (BPSD) and favorable positive emotions in demented patients.
Scientific Title:Acronym
Jia Wei Gui Pi Tang (JWGPT) trial
Region
| Japan |
Condition
Condition
dementia (AD, mixed type dementia) with BPSD (having insomnia, unsettled state of mind or neurosis)
Classification by specialty
| Geriatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Does Jia Wei Gui Pi Tang improves Behavioral and psychological symptoms of dementia (BPSD)?
Basic objectives2
Others
Basic objectives -Others
Does Jia Wei GuiPi Tang improve favorable positive emotions?
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
BPSD (NPI) change
Key secondary outcomes
positive emotions (DEI) change
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Jia Wei Gui Pi Tang 28days but rescue drug can be used.
Interventions/Control_2
No antipsychotic treatment but rescue drug can be used
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
| 65 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
AD or mixed type dementia patients who have BPSD
Key exclusion criteria
dementia not AD nor mixed type
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hidetada |
| Middle name | |
| Last name | Sasaki |
Organization
Sendai-tomizawa Hospital
Division name
President
Zip code
9820037
Address
Tomizawa Nishi 4-13-2, Taihaku Ward Sendai City
TEL
0223073375
hsasakihide@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Koh |
| Middle name | |
| Last name | Iwasaki |
Organization
Naatori-Kumaanodoh hospital
Division name
Vice President
Zip code
9811241
Address
68-1 TakadateKumanodoh Natori City
TEL
0223862131
Homepage URL
iwasaki.koh67@gmail.com
Sponsor or person
Institute
President, Sendai-Tomizawa Hospital
Institute
Department
Personal name
Funding Source
Organization
President, Sendai-Tomizawa Hosspital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Sendai-Tomizawa Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sendaai-Tomizawa Hospital
Address
114-Tomizawaterashiro, Taihaku ward, Sendaai city
Tel
022-307-3375
http://emg.or.jp/sthp/contact/
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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | 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
63
Results
We conformed that Traditional Chinese medicine Jia Wei Gui Pi Tang (JWGPT) significantly improved both BPSD and positive emotions in Delightful Emotional Index by the observer blinded randomized control study.
Results date posted
| 2022 | Year | 01 | Month | 28 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
This work was accepted by Psychogeriatrcs on 16 March 2023 as paper.
Date of the first journal publication of results
Baseline Characteristics
From October 2021 to January2021, 63 subjects (18 men and 45 women; mean age: 83.32 +/-5.96 years) at 4 institutions participated in the study.
Participant flow
From October 2021 to January 2022, 63 subjects (18 men and 45 women; mean age: 83.32 +/-5.96 years) at 4 institutions participated in the study. Participants were randomly assigned to 2 groups (control group or TCM group). Two
patients in the TCM group dropped out of the study due to aspiration pneumonia and wished to discontinue participation in the study, leaving 31 subjects in the TCM group and 30 subjects in the control group. These all completed the NPI score and DEI score before and after the observation period.
Adverse events
None
Outcome measures
NPI, EDI, MMSE
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 10 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 01 | Month | 25 | Day |
Date trial data considered complete
| 2022 | Year | 01 | Month | 25 | Day |
Date analysis concluded
| 2022 | Year | 02 | Month | 20 | Day |
Other
Other related information
Paper has been published in Psychogeriatrics online.
https://onlinelibrary.wiley.com/doi/10.1111/psyg.12962
Management information
Registered date
| 2021 | Year | 10 | Month | 04 | Day |
Last modified on
| 2023 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052113
