UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028701 |
|---|---|
| Receipt number | R000032857 |
| Scientific Title | Study on the therapeutic efficacy of conventional crude drug products 'Panaparl tablets' comprising of angelica root, cnidium rhizome, peony root, rehmannia root, etc. on cognitive impairment |
| Date of disclosure of the study information | 2017/10/01 |
| Last modified on | 2018/12/25 13:48:08 |
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Basic information
Public title
Study on the therapeutic efficacy of conventional crude drug products 'Panaparl tablets' comprising of angelica root, cnidium rhizome, peony root, rehmannia root, etc. on cognitive impairment
Acronym
Study on the therapeutic efficacy of conventional crude drug products 'Panaparl tablets' on cognitive impairment
Scientific Title
Study on the therapeutic efficacy of conventional crude drug products 'Panaparl tablets' comprising of angelica root, cnidium rhizome, peony root, rehmannia root, etc. on cognitive impairment
Scientific Title:Acronym
Study on the therapeutic efficacy of conventional crude drug products 'Panaparl tablets' on cognitive impairment
Region
| Japan |
Condition
Condition
Mild cognitive impairment and
early Alzheimer's disease
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
As there is no therapeutic strategy for Alzheimer's disease, the Japanese Kampo medicine improving the cerebral blood flow might show therapeutic effects. This study aims at investigating the therapeutic efficacy of the special Kampo 'Panaparl tablets' on mild cognitive impairment and early Alzheimer's disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Using RBANS neuropsychological test, the amnesic patients were classified into "forgetful group" with a total score of 30 to 45 and "pre-dementia group" less than 25. Before and after treatment with conventional crude drug products 'Panaparl tablets' for 3 months, the RBANS neuropsychological tests are done to elucidate its therapeutic effects on the cognitive function owing to its improvement of the cerebral blood flow.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 40 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Forgetfulness
Impairment of attention and/or concentration
Key exclusion criteria
Psychiatric disorders like visual and auditory hallucinations
Focal symptoms like hemiparesis and aphasia
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsumori Yamashima |
Organization
Arimatsu Medical and Dental Clinic
Division name
Neurosurgery and Neurology
Zip code
Address
Izumi 3-3-6, Kanazawa-City, Ishikawa, Japan
TEL
076-247-1336
yamashima215@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Ueda |
Organization
Zaiseido Pharmaceutical Co., Ltd.
Division name
Academic department
Zip code
Address
2-8-31 Oda, Wakayama-City Wakayama, Japan
TEL
073-472-3111
Homepage URL
t-ueda@zaiseido.co.jp
Sponsor or person
Institute
Arimatsu Medical and Dental Clinic
Institute
Department
Personal name
Funding Source
Organization
Zaiseido Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Senshoukai Inc. Minami-gaoka Hospital
Name of secondary funder(s)
MEXT: Ministry of Educations, Culture, Sports, Scinece and Technology - Japan
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
有松医科歯科クリニック（石川県）、扇翔会 南ヶ丘病院（石川県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
http://arimatu-clinic.com
Publication of results
Unpublished
Result
URL related to results and publications
http://arimatu-clinic.com
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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2021 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 17 | Day |
Last modified on
| 2018 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032857
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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