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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018849
Receipt No. R000021802
Scientific Title Multicenter, placebo-controlled, double-blind, randomized, parallel group trial for improvement of cognitive function by degradation of Sugar-pork liver digester (PLD)
Date of disclosure of the study information 2015/09/01
Last modified on 2019/03/02

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Basic information
Public title Multicenter, placebo-controlled, double-blind, randomized, parallel group trial for improvement of cognitive function by degradation of Sugar-pork liver digester (PLD)
Acronym Clinical study for improvement of cognitive function by PLD
Scientific Title Multicenter, placebo-controlled, double-blind, randomized, parallel group trial for improvement of cognitive function by degradation of Sugar-pork liver digester (PLD)
Scientific Title:Acronym Clinical study for improvement of cognitive function by PLD
Region
Japan

Condition
Condition Adults with decrease of cognitive function
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Study of 50 cases for cognitive function improvement of phosphatidylcholine-containing foods(PLD).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

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

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 The subjects eat 4 capsules/day (placebo) for 4 weeks
Interventions/Control_2 The subjects eat 4 capsules/day (PLD) for 4 weeks
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 over 20
(3) Subject with understanding of this study and obtain informed consent
Key exclusion criteria (1) Dementia patient
(2) Patient influences to HDS-R
(3) Subject with difficult in swallowing
(4) Subject not understanding of this study
(5) Subject received unstable therapy
(6) Subject impossible to do HDS-R and questionnaire
(7) Subject having allergy to pork meets
(8) Subject with malignant tumors, sever respiratory and sever cardiovascular disease
(9) Subject obtained no inclusion judgment
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshikazu Matsuda
Organization Nihon Pharmaceutical University
Division name Clinical Pharmacology Educational Center
Zip code
Address 10281 Komuro, Ina-machi, Kitaadachigun, Saitama, 362-0806
TEL 048-721-1155
Email yomatsuda@nichiyaku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiromu Katsuta
Organization Lelife Co., Ltd
Division name Clinical personnel development Division
Zip code
Address 1-47-1 Higashi-Ikebukuro, Toshimaku, Tokyo
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)

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 医療法人あづま会 大井戸診療所(群馬県)、医療法人 木暮医院(群馬県)、医療法人社団靜谷会 おおぞら内科・皮ふ科(東京都)

Other administrative information
Date of disclosure of the study information
2015 Year 09 Month 01 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
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 Completed
Date of protocol fixation
2015 Year 07 Month 23 Day
Date of IRB
Anticipated trial start date
2015 Year 09 Month 01 Day
Last follow-up date
2016 Year 01 Month 30 Day
Date of closure to data entry
2016 Year 01 Month 30 Day
Date trial data considered complete
2016 Year 03 Month 30 Day
Date analysis concluded
2016 Year 04 Month 28 Day

Other
Other related information

Management information
Registered date
2015 Year 08 Month 29 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/ctr_e/ctr_view.cgi?recptno=R000021802

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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