UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter and open study of sugar pork liver decomposition (PLD) on cognitive function in mild cognitive impairment patients.
Title of the study (Brief title)	Clinical evaluation for improvement of cognitive function by PLD.
Region	Japan

Condition
Condition	Mild cognitive impairment patients
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Clinical evaluation of PLD on mild cognitive impairment patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Hasegawa dementia scale (revised edition)(HDS-R) Evaluation period : pre-administar PLD, 2 week after, 4 week after
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	The subjects eat 4 capsules/day(PLD) for 1 month.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1 The age of subject is over 20 years old. 2 Subject of the HDS-R score is between 15 and 23. 3 Subject with understanding of this study and obtained informed consent.
Key exclusion criteria	1 Dementia patient with drug therapy. 2 Patient influences HDS-R such as brain disease. 3 Subject with difficult swallowing. 4 Subject without understanding of this study. 5 Subject received unstable therapy. 6 Subject impossible to do HDS-R and questionnaire. 7 Subject with allergy to pork meets. 8 Subject with malignant tumors, sever respiratory and sever cardiovascular disease. 9 Subject obtained no inclusion judgment by medical doctor.
Target sample size	15

Research contact person
Name of lead principal investigator	Yoshikazu Matsuda
Organization	Nihon Pharmaceutical University
Division name	Clinical Pharmacology Educational Center
Address	10281 Komuro, Ina-machi, Kitaadachi-gun, Saitama, 362-0806
TEL	048-721-1155
Email	yomatsuda@nichiyaku.ac.jp

Public contact
Name of contact person	Hiromu Katsuta
Organization	Lelife Co., Ltd
Division name	Clinical personnel development Division
Address	1-47-1 Higashi-Ikebukuro, Toshima-ku, Tokyo, 170-0013
TEL	03-5928-2501
Homepage URL
Email	hkatsuta@relife-inc.com

Sponsor
Institute	Nihon Pharmaceutical University
Institute
Department

Funding Source
Organization	PureLady Cosmetics Co., LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	医療法人あづま会　大井戸診療所、医療法人　木暮医院

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 18 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 02 Month 12 Day
Anticipated trial start date	2016 Year 03 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 03 Month 18 Day
Last modified on	2019 Year 03 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024825