UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Tetsumori Yamashima
Organization	Arimatsu Medical and Dental Clinic
Division name	Neurosurgery and Neurology
Address	Izumi 3-3-6, Kanazawa-City, Ishikawa, Japan
TEL	076-247-1336
Email	yamashima215@gmail.com

Public contact
Name of contact person	Takahiro Ueda
Organization	Zaiseido Pharmaceutical Co., Ltd.
Division name	Academic department
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

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 04 Month 01 Day
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

Related information
URL releasing protocol	http://arimatu-clinic.com
Publication of results	Unpublished
URL releasing results	http://arimatu-clinic.com
Results
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