UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018849 |
|---|---|
| Receipt number | 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 09:51:37 |
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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
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
hkatsuta@relife-inc.com
Sponsor or person
Institute
Nihon Pharmaceutical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021802
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
