UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021530 |
|---|---|
| Receipt number | R000024825 |
| Scientific Title | Multicenter and open study of sugar pork liver decomposition (PLD) on cognitive function in mild cognitive impairment patients. |
| Date of disclosure of the study information | 2016/03/18 |
| Last modified on | 2019/03/02 10:06:20 |
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Basic information
Public title
Multicenter and open study of sugar pork liver decomposition (PLD) on cognitive function in mild cognitive impairment patients.
Acronym
Clinical evaluation for improvement of cognitive function by PLD.
Scientific Title
Multicenter and open study of sugar pork liver decomposition (PLD) on cognitive function in mild cognitive impairment patients.
Scientific Title:Acronym
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
| 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, Kitaadachi-gun, 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, Toshima-ku, Tokyo, 170-0013
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、医療法人 木暮医院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 18 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 02 | Month | 12 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024825
| 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 |
