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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028701
Receipt No. 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

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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
Email 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
Email t-ueda@zaiseido.co.jp

Sponsor
Institute Arimatsu Medical and Dental Clinic
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032857

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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